OIVD News Archive
FDA invites the CEO of Lab. Corp. to discuss strategies for clinical validation of the OvaSure™ Test.
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration. August 7, 2008
The Food and Drug Administration (FDA) obtained information that Laboratory Corporation of America (LabCorp) is marketing OvaSure™ for Ovarian Cancer with unclear clinical validation status.
In a letter to the President and Chief Executive Officer of LabCorp the FDA stated that the review of LabCorp’s promotional material revealed that LabCorp is offering a high risk test that has not received adequate clinical validation, and may harm the public health. In this letter the FDA invited LabCorp to discuss validation strategies undertaken by LabCorp for marketing the OvaSure™ test.
FDA Reminds manufacturers of Class II or Class III in vitro diagnostic devices, that are currently inappropriately labeled and marketed as ASRs, to comply with the law by September 15, 2008
Source: Food and Drug Administration (FDA), Center for Device and Radiological Heath (CDRH), Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), June 6, 2008
On Friday, June 6, 2008, FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Device and Radiological Heath, issued a letter to manufacturers who have a listed Analyte Specific Reagents (ASRs) with the FDA, reminding them to ensure their Class II or Class III in vitro diagnostic devices, that are currently inappropriately labeled and marketed as ASRs, comply with the law by September 15, 2008.
In this letter the FDA states that in addition to premarket submissions, it is willing to also accept pre-IDE submissions before September 15, 2008. The FDA advises that the pre-IDE include a clear plan for each device with a premarket time line for submission and a detailed outline of the intended use and studies/data that are planned for the premarket submission(s). FDA intends to work interactively with manufacturers to reach agreement on a premarket submission plan and in those cases where agreement is reached in a timely manner; the FDA intends to notify the manufacturers that the premarket submission plan is acceptable.
The FDA warns that if agreement is not reached on an acceptable plan, or if manufacturers do not pursue the agreed up on plan in good faith, then the FDA may take enforcement action with respect to the affected products.
For more information see the Reminder Letter.
Towards an Artificial Pancreas: FDA, NIH, & JDRF Workshop on July 21-22, 2008
Source: The Office of In Vitro Diagnostic Devices at the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and National Institutes of Health (NIH) and the Juvenile Diabetes Research Foundation (JDRF), April 30, 2008
The Food and Drug Administration (FDA), in collaboration with the National Institutes of Health (NIH) and the Juvenile Diabetes Research Foundation (JDRF), is holding a public workshop focused upon the state of the art in the research and development of an artificial pancreas. The workshop “Towards an Artificial Pancreas: An FDA-NIH-JDRF Workshop” will provide a public forum for discussing the progress and remaining challenges in the development of closed-loop systems designed to regulate glycemic control, as an aid in the management of diabetes mellitus. It is intended to provide stakeholders with information that will accelerate the development of an artificial pancreas.
The workshop will be held on July 21, 2008 from 7:55 a.m. to 6:00 p.m., and on July 22, 2008 from 8:00 a.m. to 12:45 p.m. Registration is free and On-line registration is available at http://www.blsmeetings.net/h1368%2D4/reg.cfm until 5:00 p.m. on June 20, 2008
For more information see the Workshop’s Webpage and the Workshop’s Agenda.
FDA Reminds Healthcare Professionals About Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter
Source: Food and Drug Administration, Center for Biologics Evaluation and Research, April 17, 2008.
This notice is intended to alert physicians, nurses, medical technologists, pharmacists and other healthcare professionals, who perform glucose monitoring, of the potential for life-threatening falsely elevated glucose readings in patients who have received drug products containing maltose, galactose, icodextrin , or d-xylose, and subsequently tested using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems. The GDH-PQQ method of glucose determination is non-specific for glucose and in the presence of maltose, galactose, icodextrin, or d-xylose, may yield falsely elevated glucose readings.
For more detail see the FDA’s Article entitled Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product.
FDA Reminds Glucose Meter Users to Only Use Strips Recommended For Their Meter
Source: Food and Drug Administration, office of In Vitro Diagnostic Devices, March, 8, 2008
The purpose of this notice is to remind users of blood glucose meters to read the instructions for use carefully and to only use test strips recommended for their meter by the blood glucose meter’s manufacturer. While this problem has been identified recently as occurring with a unique meter-strip configuration, FDA recognizes that similar problems can also occur if other brands and models of meters and strips are not used in proper combination.
FDA Publishes a New Guidance Document on Detection and Differentiation of Influenza Viruses
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, February 15, 2008
FDA is issuing this draft guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of influenza viruses. These devices are used to aid in the diagnosis of influenza infection. They include devices that detect one specific type or subtype, as well as devices that detect more than one type or subtype of influenza virus and further differentiate among them, to indicate whether the specimen contains influenza A virus versus influenza B virus, or which subtype of influenza A is present. This guidance provides detailed information on the types of studies FDA recommends to support Class I and Class I1 premarket submissions for these devices. The guidance includes a list of influenza virus strains recommended for analytical sensitivity studies, a list of microorganisms recommended for analytical specificity studies, and an example of a suggested format for presenting data from cross-reactivity studies.
This document is limited to studies intended to establish the performance characteristics of devices that detect either influenza viral antigens or influenza viral genome (protein or nucleic acid). It includes rapid detection devices and nucleic acid-based devices. It does not address detection of serological response from the host to the viral antigen, nor does it address establishing performance of non-influenza components of multi-analyte or multiplex devices.
For more information see the Guidance Document.
FDA Publishes Final Guidance Document on CLIA’ 88 Waiver Applications
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, January 30, 2008
This guidance describes recommendations for device manufacturers seeking to submit information through a CLIA waiver application to FDA to support a determination whether the device meets CLIA statutory criteria for waiver. In this document, FDA recommends an approach to demonstrating that an in vitro diagnostic device is simple and has an insignificant risk of an erroneous result. As part of demonstrating the latter, FDA recommends studies to be conducted to demonstrate the test is "accurate."
This document does not address test systems cleared or approved by FDA for over-the-counter or prescription home use since these automatically qualify for CLIA waiver. 42 U.S.C. 263a(d)(3). This guidance document also does not address use of the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)’s replacement reagent and instrument family policy for waived devices; that policy does not currently apply to CLIA waiver applications.
The recommendations in this document is based on FDA’s interpretation of the law, experience with CLIA complexity determinations, and interactions with stakeholders.
Some of the changes reflected in this document (as well as in the 2005 draft guidance document) from the earlier 2001 draft guidance document entitled “Guidance for CLIA 1988 Criteria for Waiver,” include the following:
- Greater emphasis on scientifically-based flex studies 2 and validation and/or verification studies, linked to the risk assessment for each device.
- Recognition that reference methods may not be available for every device type. (However, devices should be traceable to true reference methods of known accuracy, when such methods are available.)
- Additional emphasis on use of quality control procedures.
- Greater emphasis on intended users (which may include medical assistants, nurses or doctors, and lay people, as appropriate) during studies testing the device.
- Updated study recommendations with emphasis on use of patient specimens, in an intended use environment, over time.
For more information see the Guidance Document.
FDA Joins NIH in Awareness Campaign for Hemoglobin A1c Testing
Source: FDA, January 29, 2008
FDA joins a new information campaign of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) that highlights the importance of using accurate methods to test hemoglobin A1c in people with diabetes who have sickle cell trait or other inherited forms of variant hemoglobin.
Intensive control of blood glucose reduces complications of diabetes. The hemoglobin A1c blood test (or simply the A1c test) is an essential tool in diabetes care because it shows a patient’s average level of blood glucose control in the previous 2 to 3 months. Physicians base their treatment decisions in large part on the A1c test results. Inaccurate A1c readings, whether falsely high or low, may lead to the over treatment or under treatment of diabetes.
It has become evident that some of the FDA cleared A1c assays do not accurately measure the hemoglobin A1c in African, Mediterranean, and southeast Asian patients with hemoglobin variant S (HgS), also known as sickle cell trait, and variant C (HgC), another common variant in the United States. For a list of test methods often used to measure hemoglobin A1c and whether the method is affected by either HgS or Hgb C trait go to the National Glycohemoglobin Standardization Program (NGSP) web page at the University of Missouri School of Medicine, that is working to improve and standardize the measurement of A1c in laboratories around the world.
Go to NIH and NIDDK web page for more information on this informational campaign.
OIVD’s Shortcuts on the Critical Path to the Market, February 19, 2008
Source: The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), Clinical Device Group (CDG), and the Food and Drug Law Institute (FDLI), January 24, 2008
The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Clinical Device Group (CDG), and the Biomedical Engineering Alliance and Consortium (BEACON), will co-sponsor the IVD eConference “OIVD’s Shortcuts on the Critical Path to the Market” on February 19, 2008. The objective of the eConference is to foster communication between the professional, manufacturing and regulatory community.This eConference provides an opportunity to hear about the shortcuts OIVD is taking on the IVD’s critical path to the market.
For eConference descriptions and Registration go to Clinical Device Group Inc. webpage.
OIVD Conducts the Annual 510(k) Workshop on April 22-23, 2008
Source: Source: The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM), January 15, 2008
The Office of In Vitro Diagnostic Devices (OIVD) at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM) will co-sponsor the OIVD’s Annual 510(k) Workshop on April 22-23, 2008 at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, N. Bethesda, Maryland. The objective of the Annual 510(k) Workshop is to foster communication between the professional, manufacturing and regulatory community. This interactive workshop provides an opportunity to hear about 510(k) submissions from the FDA people who actually review the submissions. Helpful tips and guidance from experienced industry regulatory affairs personnel will also be provided.
In an effort to encourage the industry to use the electronic 510(k) submission program (Turbo 510(k) program) OIVD has organized a half a day hands on training for the participants to complete and package for submission an electronic 510(k). To participate in this hands-on interactive training session participants must have a laptop; OIVD will provide CDs for loading the software onto the laptops.
For more information see the Agenda.
Click here to see Registration information.
FDA Encourages the In Vitro Diagnostic Community to Comment on the Draft Report to the Secretary of Health and Human Services (HHS) on the Oversight of Genetic Testing
Source: Office of Biotechnology Activities, National Institutes of Health, November 2007
The Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) is seeking public comment on a Draft Report to the Secretary of Health and Human Services (HHS) on the oversight of genetic testing. FDA encourages all the stockholders to submit comments on the draft report to SACGHS by December 21, 2007. Comments received by December 21, 2007 will be considered by SACGHS in preparing its final report. Please submit comments to SACGHS by emailing them to Cathy Fomous, Ph.D. at cfomous@od.nih.gov. Alternatively, comments may be mailed or faxed to:
Secretary’s Advisory Committee on Genetics, Health, and Society
Attn: Cathy Fomous, Ph.D.
NIH Office of Biotechnology Activities
6705 Rockledge Drive, Suite 700
Bethesda, MD, 20892 (20817 for non-US Postal Service mail)
Fax: 301-496-9839
In addition to submitting written comments, the FDA encourages the stakeholders to participate in a public meeting held by SACGHS on November 19-20, 2007 to provide testimony on this topic. The public meeting is being held at the Ronald Reagan Building, Washington, DC. For more information on the public meeting see the Agenda.
For more information about the SACGHS committee, please visit:
http://www4.od.nih.gov/oba/SACGHS.HTM
FDA Publishes a New Guidance Document entitled IVD Device Studies - Frequently Asked Questions
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, October 25, 2007
This guidance document, written in question and answer format, is intended to assist the manufacturer, sponsor, applicant, investigator and the IVD device industry in the development of IVD studies, particularly those exempt from most of the requirements of the Investigational Device Exemptions (IDE) regulation and to provide a broad view of the regulatory framework pertaining to the development phase of IVD devices. The information in this guidance document is also pertinent to investigators who participate in IVD studies and to institutional review boards (IRB) that review and approve such studies. The document is intended to facilitate the movement of new IVD technology from the investigational stage to the marketing stage.
This guidance document outlines FDA regulations applicable to studies for investigational IVD devices, including those regulations related to human subject protection. The guidance also explains data considerations that ultimately will affect the quality of the premarket submission. This document includes a glossary, a reference list with related web addresses, and a quick-reference table.
For more information see the Guidance Document.
FDA Clears Genetic Lab Test for Warfarin Sensitivity Source: Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Food and Drug Administration (FDA), September 17, 2007
The FDA cleared for marketing a new genetic test that will help physicians assess whether a patient may be especially sensitive to the blood-thinning drug warfarin (Coumadin), which is used to prevent potentially fatal clots in blood vessels.
The Nanosphere test is not intended to be a stand-alone tool to determine optimum drug dosage, but should be used along with clinical evaluation and other tools, including prothrombin time (PT) and International Normalized Ratio (INR), to determine the best treatment for patients.
The Nanosphere test was cleared for use on the Verigene System, a clinical laboratory test system. Both products are manufactured by Nanosphere Inc., Northbrook, Ill.
For more information on Nanosphere test, read the FDA's Press Release.
FDA Again Clarifies the Analyte Specific Reagents (ASRs) Rule and its Requirements
Source: Guidance for Industry and FDA Staff- Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions, issued September 14, 2007
In 1997, FDA issued a rule on Analyte Specific Reagents (ASRs), which defined and classified the substances, imposed restrictions on their sale, distribution and use, and established their labeling requirements. This guidance document is intended to clarify the regulations regarding commercially distributed ASRs and the role and responsibilities of ASR manufacturers. The draft of this guidance was issued September 7, 2006. FDA received and considered more than 30 sets of comments on the draft guidance document. After taking the comments into consideration, the FDA has revised the draft document to provide clarifications as needed. This includes clarifying that FDA views ASRs as agents intended to detect a single ligand or target. This change further clarifies that oligonucleotide primer pairs and polyclonal antibodies can meet the definition of an ASR when properly marketed because they are for the identification of a single target or ligand (e.g., used to detect a single protein, a single nucleotide change, a single epitope). In addition, FDA has clarified that where manufacturers provide laboratories with information describing the use of their product in a specific test, the manufacturer's product would fall outside the definition of an ASR.
In order to assist manufacturers of Class II or III in vitro diagnostic devices that are currently being inappropriately labeled and marketed as ASRs to come into regulatory compliance, FDA intends to exercise enforcement discretion with respect to premarket approval and clearance requirements for such products for twelve months following the publication of the notice of availability of the final guidance. Manufacturers should ensure their products comply with the law by September 15, 2008.
A notice of availability has been submitted to the Federal Register.
For more information see the Guidance Document.
FDA Issues Guidance on Procedures for Handling Post-Approval Studies
Source: Office of Surveillance and Biometrics, Center for Devices and Radiological Health, the Food and Drug Administration (FDA), August 1, 2007
Evaluation of Premarket Approval Applications (PMAs) by the Center for Devices and Radiological Health (CDRH) is a multi-step process in which CDRH evaluates the sponsor’s information to reach the final decision on whether a product can be approved. To help assure the continued safety and effectiveness of an approved device, CDRH may require a post-approval study (also referred to as Condition of Approval or Post-Approval studies).
The goal of this guidance is to provide recommendations to sponsors and CDRH staff on expectations concerning format, content, and review of reports related to post-approval studies to help ensure that the studies are conducted effectively and efficiently, and in the least burdensome manner. Although some post-approval studies may involve animal or laboratory bench studies, the recommendations in this guidance focus on clinical post-approval studies. The FDA intends for these recommendations to improve post-approval studies by:
- helping the Center and sponsors ensure consistency in post-approval submissions;
- helping all stakeholders to easily and quickly identify and track post-approval studies;
- enhancing sponsor and CDRH discussions on mutually understood study objectives;
- facilitating timely discourse on study issues and challenges; and
- providing opportunities to resolve issues.
In sum, these improvements are intended to enhance information about marketed devices by ensuring that appropriate post-approval studies are efficiently initiated, conducted, completed, and reviewed.
For more information see the Guidance Document.
FDA Publishes a Revised Draft Guidance Document for In Vitro Diagnostic Multivariate Index Assays
Source: Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays issued July 26, 2007
The FDA issued a revised draft guidance document entitled “In Vitro Diagnostic Multivariate Index Assays” to address the definition and regulatory status of a class of In Vitro Diagnostic Devices referred to as In Vitro Diagnostic Multivariate Index Assays (IVDMIAs). The revised draft guidance which is issued with a 30-day comment period addresses premarket and postmarket requirements with respect to IVDMIAs. The initial draft of this guidance was issued September 7, 2006 with a 90-day comment period. The FDA then extended the comment period on the draft guidance document from 90 days to 180 days, and held a public meeting on February 8, 2007 to provide a forum for presentations and comments on the draft guidance document.
FDA has carefully considered the 60 sets of comments it has received on the initial draft guidance document and has revised the draft guidance document to provide clarifications as needed. With this revised draft guidance document, FDA seeks to identify IVDMIAs as a discrete category of device, and to clarify that, even when offered as LDTs, IVDMIAs must meet pre- and post-market device requirements under the Act and FDA regulations, including premarket review requirements in the case of most class II and III devices.
The revised draft guidance document now clarifies FDA regulatory mechanisms in general, such as how devices are classified and reviewed based on the risk of the intended use, how laboratory-developed IVDMIAs should be labeled, and how manufacturers can update and improve cleared or approved devices using existing mechanisms within the regulatory framework. These existing mechanisms enable manufacturers to bring innovative new tests to the market and ensure that they can be updated and improved as new scientific information becomes available. While this information is generally available in existing regulations, guidance documents, and on the FDA web site, the revised draft guidance provides a summary of this information with a focus on IVDMIAs in order to assist those stakeholders who are not familiar with existing FDA requirements.
A notice has been submitted to the Federal Register. The agency is accepting public comment for 30 days from the date of publication in the Federal Register. Electronic comments may be sent to www.fda.gov/dockets/ecomments. Written comments may be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments must include the docket number (2006D-0347).
For more information see the Draft Guidance Document.
FDA Approved the First Molecular-Based Test to Detect Metastatic Breast Cancer
Source: Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Food and Drug Administration (FDA), July 16, 2007
The FDA approved for marketing the first molecular-based laboratory test that determines whether breast cancer has spread (metastasized) to nearby lymph nodes. The GeneSearch BLN test, manufactured by Veridex, a Johnson & Johnson Company, of Warren, N.J., detects molecules that are abundant in breast tissue but scarce in a normal lymph node.
The presence or absence of breast cancer cells in underarm lymph nodes is a powerful predictor of whether the cancer has spread and is used to help decide appropriate therapy for a woman with metastatic breast cancer.
For more information on GeneSearch BLN test , read the FDA’s Press Release.
FDA Publishes a Guidance Document for Pharmacogenetic Tests and Genetic Tests for Heritable Markers
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, June 19. 2007
This guidance document provides recommendations to sponsors and FDA reviewers in preparing and reviewing premarket approval applications (PMA) and premarket notification (510(k)) submissions for pharmacogenetic and other human genetic tests, whether testing is for single markers or for multiple markers simultaneously (multiplex tests). Array-based tests (commonly referred to as microarrays) are a subset of multiplex tests and are included in the scope of this document. The recommendations within this guidance for elements of a genetic test submission apply to pharmacogenetic (e.g., drug-metabolizing enzyme allele tests, single nucleotide polymorphism (SNP) analysis) and other types of genetic tests. Tests of gene expression and tests for non-heritable (somatic) mutations are not specifically addressed. This guidance considers nucleic acid-based analysis only, but the principles may be applied to other matrices (e.g., protein) when the purpose is to provide genetic information.
For more information see the Guidance Document and the Federal Register notices.
FDA Clears the First Quick test for Malaria
Source: Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Food and Drug Administration (FDA), June 4, 2007
The FDA cleared for marketing the first rapid test for malaria, a mosquito-borne disease caused by a parasite.
The Binax NOW test is manufactured by Binax Inc., a subsidiary of Inverness Medical Innovations Inc. of Scarborough, ME and is intended for laboratory use.
The Binax NOW test is significantly faster than the traditional microscopic method for detection of malaria and it is easier to use. Results are available in 15 minutes after a few drops of whole blood are placed on a dipstick. The test can differentiate between Plasmodium falciparum, and the other Plasmodium species. Results still need to be confirmed using standard microscopic evaluation.
For more information on Binax NOW test, read the FDA’s Press Release and the CDRH’s Information for Consumers.
For more information on malaria consult CDC at www.cdc.gov/malaria/
OIVD Changes Phone Numbers
Source: Office of In Vitro Diagnostic Device Evaluation and Safety January 1, 2007
The phone numbers for the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) has changed. Please make a note of the following changes
Steve Gutman, M.D., MPH, Director, OIVD
Phone: 240-276-0375
Fax: 240-276-0652
Alberto Gutierrez, Ph.D., Deputy Director, New Device Evaluation, OIVD
Phone: 240-276-0376
Fax: 240-276-0652
James Woods, Deputy Director, Patient Safety and Product Quality, OIVD
Phone: 240-276-0377
Fax: 240-276-0652
Sousan Altaie, Ph.D., Scientific Policy Advisor, OIVD
Phone: 240-276-0378
Fax: 240-276-0643
Sally Hoijvat, M.Sc., Ph.D. Director, Devision of Microbiology Devices
Phone: 240-276-0496
Fax: 240-276-0652
Robert Becker, Jr., M.D., Ph.D., Director, Division of Immunology and Hematology Devices
Phone: 240-276-0403
Fax: 240-276-0663
Jean Cooper, DVM, Director, Division of Chemistry and Toxicology
Phone: 240-276-0490
Fax: 240-276-0651
For the changes to the phone numbers of all OIVD staff click here.
FDA Clears the First 7-Day Continuous Glucose Monitoring System
Source: Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Food and Drug Administration (FDA), June 4, 2007
The FDA cleared for marketing the first device that measures glucose levels continuously for up to seven days in people with diabetes.
While a standard fingerstick glucose test records a person’s glucose level as a snapshot in time, the STS-7 Continuous Glucose Monitoring System (manufactured by DexCom Inc. of San Diego, Calif.), measures glucose levels every five minutes throughout a seven-day period. This additional information can be used to detect trends and track patterns in glucose levels throughout the week that wouldn’t be captured by fingerstick glucose measurements alone. However, diabetics must still rely on the fingerstick glucose test to decide whether additional insulin is needed.
For more information on STS-7 Continuous Glucose Monitoring System, read the FDA’s Press Release.
Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.
Source: Guidance for Industry and FDA Staff- Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays issued on: January 9, 2006.
This special controls guidance document was developed to support the reclassification of the herpes simplex virus types 1 and 2 (HSV 1 and 2) serological assays into class II. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.
For more information see the Guidance Document.
FDA issues a warning letter to Seryx, Inc.
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration. February 22, 2007
Based on FDA’s review of the Seryx’s internet website, www.seryx.com and the information obtained in the FDA’s meeting with Seryx on May 23, 2006 it was determined that Seryx is marketing the Signature Genetics system that contains software used to analyze data and generate a patient-specific report via interpretation of a patient's genotype for several drug metabolizing enzymes. Since the patient-specific report included recommendations to the health care provider about whether a patient's therapy should be adjusted and/or whether there are possible drug drug interactions the FDA issued a Warning Letter to Seryx and stated that under section 201(h) of the Act. this software is a device because it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. The Warning Letter stated that the law requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from FDA before they may offer them for sale and invited Seryx to promptly correct the violation.
Information is available in the FDA Warning Letter to Seryx (PDF).
FDA Publishes a New Guidance Document on Reporting Results from Studies Evaluating Diagnostic Tests
Source: Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, March 13, 2007
This guidance is intended to describe some statistically appropriate practices for reporting results from different studies evaluating diagnostic tests and identify some common inappropriate practices. The recommendations in this guidance pertain to diagnostic tests where the final result is qualitative (even if the underlying measurement is quantitative). The guidance gives a special attention to the practice called discrepant resolution and its associated problems.
This document provides guidance for the submission of premarket notification [510(k)] and premarket approval (PMA) applications for diagnostic devices (tests). This guidance addresses the reporting of results from different types of studies evaluating diagnostic devices with two possible outcomes (positive or negative) in PMAs and 510(k)s. The guidance is intended for both statisticians and non-statisticians.
This guidance does not address the fundamental statistical issues associated with design and monitoring of clinical studies for diagnostic devices.
For more information see the Guidance Document and the Federal Register Notice .
OIVD Conducts the Annual 510(k) Workshop on April 17-18, 2007
Source: The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM), February 15, 2007
The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM) will co-sponsor the OIVD’s Annual 510(k) Workshop on April 17-18, 2007 at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, N. Bethesda, Maryland. The objective of the Annual 510(k) Workshop is to foster communication between the professional, manufacturing and regulatory community. This interactive workshop provides an opportunity to hear about 510(k) submissions from the FDA people who actually review the submissions. Helpful tips and guidance from experienced industry regulatory affairs personnel will also be provided.
For more information see the Agenda.
To register, see Registration Information.
The Transcript of the Public Meeting on the Guidance Document for IVDMIAs are Now Available
Source: FDA, February 26, 2007
The Office of In Vitro Diagnostic evaluation and Safety (OIVD) held a public meeting on February 8, 2007, at the Hilton Washington DC/ Gaithersburg Hotel to hear presentations and comments from the stakeholders on the “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.”
For more information see the Transcripts.
OIVD Conducts the Annual 510(k) Workshop on April 17-18, 2007
Source: The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM), February 15, 2007
The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM) will co-sponsor the OIVD’s Annual 510(k) Workshop on April 17-18, 2007 at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, N. Bethesda, Maryland. The objective of the Annual 510(k) Workshop is to foster communication between the professional, manufacturing and regulatory community. This interactive workshop provides an opportunity to hear about 510(k) submissions from the FDA people who actually review the submissions. Helpful tips and guidance from experienced industry regulatory affairs personnel will also be provided.
For more information see the Agenda.
To register, see Registration Information.
FDA Clears the First In Vitro Diagnostic Multivariate Index Assay (IVDMIA)
Source: Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Food and Drug Administration (FDA), February 6, 2007
The FDA cleared for marketing MammaPrint test that determines the likelihood of breast cancer returning within five to 10 years after a woman’s initial cancer. It is the first cleared molecular test that has claims for genetic profiling for breast cancer prognosis.
The recurrence of cancer is partly dependent on the activation and suppression of certain genes located in the tumor. Prognostic tests like the MammaPrint can measure the activity of these genes, and thus help physicians understand their patients’ odds of the cancer spreading.
The MammaPrint test developed by Agendia, a laboratory located in Amsterdam, Netherlands, uses the latest in molecular technology to predict whether existing cancer will metastasize (spread to other parts of a patient’s body). The test relies on microarray analysis, a powerful tool for simultaneously studying the patterns of behavior of large numbers of genes in biological specimens.
For more information on MammaPrint test, read the FDA’s Press Release.
To find out what Dr. Steve Gutman, Director of the Office of In Vitro Diagnostic Device Evaluation and Safety told the press about the test see MedPage Today and drkoop.com.
For more information on breast cancer visit the American Cancer Society.
OIVD Holds a Public Meeting on the Guidance Document for IVDMIAs
Source: FDA, December 2006
The Office of In Vitro Diagnostic evaluation and Safety (OIVD) is holding a public meeting on In Vitro Diagnostic Multivariate Index Assays. The meeting is intended to provide a public forum during which OIVD will hear presentations and comments from interested stakeholders regarding the draft guidance entitled, “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.” This draft guidance is intended to provide clarification on FDA’s approach to regulation of in vitro diagnostic multivariate index assays.
The public meeting will be held on February 8, 2007, from 8:00 a.m. to 5:00 p.m. at the Grand Ballroom of the Hilton Washington DC/Gaithersburg Hotel located at 620 Perry Parkway, Gaithersburg, Maryland, 20877.
The Agenda for this public meeting will be available on February 7, 2007. FDA will start the meeting with a brief presentation on the draft guidance document and presentations by the public will make-up the remainder of the agenda.
Interested persons who would like to make a presentation during the meeting will be given 10 minutes to do so if they submit their request and a written or electronic copy of the material to be presented by February 1, 2007, to the contact person, Sousan Altaie, Center for Devices and Radiological Health, Food and Drug Administration, HFZ-440, 2098 Gaither Road, Rockville, MD 20850, Phone: 240-276-0450, ext. 106, email: Sousan.Altaie@fda.hhs.gov AND to the Docket for this draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the draft guidance to eComments. Identify comments with the docket number 2006D-0347.
Depending upon the number of presenters submitting requests to present, the allotted time may be expanded or shortened to provide appropriate representation by all interested parties.
There is no registration fee to attend the meeting. Please submit registration early in order to reserve a space, as space is limited. You may register on-line until February 5, 2007; however, on-site registration will be permitted if space remains. If you require special accommodations due to a disability, please contact the Hilton Washington DC/ Gaithersburg Hotel directly at 1-301-977-8900, at least 7 days in advance.
For more information see the Federal Register notice.
Class I Recall: Counterfeit OneTouch® Ultra® Blood Glucose Test Strips
Source: Office of In Vitro Diagnostics, CDRH/FDA October 19, 2006
Discount Diabetic Supply in Oxford, Mississippi recalled the 50 - count packages (2 vials of 25 test strips).of counterfeit OneTouch® Ultra® Blood Glucose Test Strips (Lot Numbers 2691191 and 2691261), in English and French. These blood glucose test strips are counterfeit versions of LifeScan’s products. These counterfeit test strips could give incorrect blood glucose values, either too high or too low, which might result in a patient taking either too much or too little insulin. This could lead to serious injury or death.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
In addition to the device and lot number listed in this Class I Recall, the following devices and lot numbers have also been determined to be counterfeit test strips:
- OneTouch® Basic®/Profil®e blood glucose test strips lot numbers 272894A, 2619932, 2606340, 2615211 and 227078A
Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Consumers with questions may also contact LifeScan at: 1-866-621-4855.
For more information see FDA’s Nationwide Alert or the LifeScan’s Alert on Counterfeit Blood Glucose Test Strips
Class I Recall: Counterfeit OneTouch® Basic®/Profile® Blood Glucose Test Strips
Source: Office of In Vitro Diagnostics, CDRH/FDA October 17, 2006
Medishop Inc. in Brooklyn, New York recalled the 50-count packages of counterfeit OneTouch® Basic®/Profile® blood glucose test strips (Lot Numbers 272894A, 2619932, 2606340, 227078A, and 2615211), in English, Greek and Portuguese. These blood glucose test strips are counterfeit versions of LifeScan’s products. These counterfeit test strips could give incorrect blood glucose values, either too high or too low, which might result in a patient taking either too much or too little insulin. This could lead to serious injury or death.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
In addition to the device and lot numbers listed in this Class 1 Recall, the following devices and lot numbers have also been determined to be counterfeit test strips:
- OneTouch® Ultra® blood glucose test strips lot numbers 2691191 and 2691261
Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Consumers with questions may also contact LifeScan at: 1-866-621-4855.
For more information see FDA’s Nationwide Alert or the LifeScan’s Alert on Counterfeit Blood Glucose Test Strips
FDA Extends the Comment Period on the IVD MIA Draft Guidance document
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, November 28, 2006
The Food and Drug Administration (FDA) is extending the comment period on the “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.” The agency announced the availability of this draft guidance in the Federal Register of September 7, 2006 (71 FR 52800). The initial comment period closes on December 6, 2006. To provide interested persons additional time to review and submit comments on the draft guidance, the agency has decided to extend the comment period another 90 days to end on March 5, 2007.
A notice has been submitted to the Federal Register. Electronic comments may be submitted to www.fda.gov/dockets/ecomments. Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must include the docket number (2006D-0347).
For more information see the Draft Guidance Document.
FDA Extends the Comment Period on the ASR Draft Guidance Document
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, November 28, 2006
The Food and Drug Administration (FDA) is extending the comment period on the draft guidance entitled “Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.” FDA announced the availability of this draft guidance in the Federal Register of September 7, 2006 (71 FR 52799). The initial comment period closes on December 6, 2006. To provide interested persons additional time to review and submit comments on the draft guidance, FDA has decided to extend the comment period.
A notice has been submitted to the Federal Register. Electronic comments may be submitted to www.fda.gov/dockets/ecomments. Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must include the docket number (2006D-0336).
For more information see the Draft Guidance Document.
Up Coming OIVD’s Clinical Chemistry and Clinical Toxicology Devices Panel Meeting
Source: Advisory Committee Coordinator, Center for Devices and Radiological Health, Food and Drug Administration. November 24, 2006
The FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee will hold an open public meeting on December 6, 2006, from 8:00 AM to 4:30 PM at the Holiday Inn, Ballroom, Two Montgomery Village Ave. Gaithersburg, MD. The committee will hear an update on the status of recent devices brought before the committee. The committee will also hear a presentation regarding the FDA Critical Path Initiative and will discuss general issues concerning lipoprotein (HDL and LDL) subfraction assays. Background information for the topic, including the agenda and questions for the committee, will be available to the public one business day before the meeting at: http://www.fda.gov/cdrh/panel/index.html (click on Upcoming CDRH Advisory Panel/Committee Meetings).
For more information, please see the Federal Register notice. (link to :http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-19492.htm)
Upcoming OIVD’s Immunology Devices Panel Meeting
Source: Advisory Committee Coordinator, Center for Devices and Radiological Health, Food and Drug Administration. October 5, 2006
The FDA’s Immunology Devices Panel of the Medical Devices Advisory Committee will hold an open public meeting on November 16, 2006 from 8:00 AM - 5:00 PM at the Holiday Inn, Walker/Whetstone rooms, Two Montgomery Village Ave., Gaithersburg, MD.
The committee will discuss, make recommendations, and vote on a premarket approval application for a laboratory assay designed for the rapid detection of clinically relevant (greater than 0.2 millimeters) metastases in lymph node tissue removed from breast cancer patients. Results from the assay can be used to guide the surgeon's decision to excise additional lymph nodes and aid in staging.
Background information for the topic, including the agenda and questions for the committee, will be available to the public one business day before the meeting at the meeting page.
For more information, please see the Federal Register notice.
FDA Issues Nationwide Alert on Counterfeit Blood Glucose Test Strips
Source: The Food and Drug Administration (FDA), October 17, 2006
In a nationwide issued alert the FDA notified the public about the counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors used by people with diabetes to measure their blood glucose. The FDA alerted the public that the counterfeit test strips potentially could give incorrect blood glucose values (either too high or too low) which might result in a patient taking either too much or too little insulin and lead to serious injury or death.
The counterfeit test strips have been identified as the One Touch Basic®/Profile® (lot #272894A, 2619932 or 2606340) and the One Touch Ultra® (lot #2691191).
The FDA is advising the consumers who have the counterfeit test strips to stop using them, replace them immediately and contact their physician. For tips as to how to identify the counterfeit strips visit FDA’s Alert release.
The FDA is alerting its Counterfeit Alert Network partners, a coalition of healthcare professional, consumer and trade associations, who have agreed to further disseminate this important information in a timely and effective manner. LifeScan is alerting the public via a press release and is notifying pharmacists, distributors, and wholesalers through a letter. Consumers with questions may contact the company at 1-866-621-4855.
Any adverse reactions experienced with the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD, 20852-9787, or through the MedWatch Web site at www.fda.gov/medwatch.
FDA Waives the LeadCare II Blood Lead Test System to broaden Access to Lead Testing
Source: The Food and Drug Administration (FDA), September 14. 2006
The U.S. Food and Drug Administration (FDA) expanded the availability of the first simple and portable lead test system to more than 115,000 certified point-of-care locations nationwide, including healthcare clinics, mobile health units and schools. This will allow children and adults to be tested and treated for lead poisoning much easier and faster.
The test, called the LeadCare II Blood Lead Test System and made by ESA Biosciences of Chelmsford, Mass., is used to screen children and adults for harmful levels of lead using a finger stick or venous whole blood sample. It is performed while the patient is present, in as little as three minutes. The rapid result means a second sample for confirmatory testing can be obtained quickly, reducing the need for a follow-up visit.
FDA broadened access to the test system by granting a Clinical Laboratory Improvement Amendment (CLIA) waiver, because the test is simple, accurate and reasonably free of harm. This waiver permits widespread distribution to nontraditional laboratory sites that have CLIA certification.
The ease and accuracy of the test system was evaluated by testing 516 blood samples over a two-month period at 11 sites. The test instrument applies an electrical current to the patient’s blood sample, causing lead to collect on disposable sensors. Studies show nearly 98 percent of the values measured by the test instrument were within Occupational Safety and Health Administration’s recommendations for blood lead proficiency testing. Blood lead values above 10 milligrams per deciliter need to be confirmed with another laboratory method.
For more information see:
For more information on lead, visit:
For more information on how the FDA cleared the LeadCare II Blood Lead Test System, go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=19475
FDA Clarifies the Analyte Specific Reagents (ASRs) Rule and its Requirements
Source: Guidance for Industry and FDA Staff- Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions, issued September 7, 2006
In 1997, FDA issued a rule on Analyte Specific Reagents (ASRs), which defined and classified the substances, imposed restrictions on their sale, distribution and use, and established their labeling requirements. This draft guidance document is intended to clarify the regulations regarding commercially distributed ASRs and the role and responsibilities of ASR manufacturers. The draft guidance provides information on the 1997 ASR rule and its requirements; examples of entities that FDA does and does not consider to be ASRs; ASR manufacturers' marketing practices; and the research and investigational use of ASRs. FDA is providing this guidance in order to eliminate confusion regarding particular marketing practices among ASR manufacturers. With this draft guidance document, FDA seeks to advise ASR manufacturers that it views the following practices as being inconsistent with the marketing of an ASR:
- Combining, or promoting for use, a single ASR with another product such as other ASRs, general purpose reagents, controls, laboratory equipment, software, etc.
- Promoting an ASR with specific analytical or clinical performance claims, instructions for use in a particular test, or instructions for validation of a specific test using the ASR.
A notice has been submitted to the Federal Register. The agency is accepting public comment for 90 days from the date of publication in the Federal Register. Comments may be sent to www.fda.gov/dockets/ecomments. Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must include the docket number (2006D-0336).
For more information see the Guidance Document and the Press Release
FDA Publishes a New Draft Guidance Document for In Vitro Diagnostic Multivariate Index Assays
Source: Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays issued September 7, 2006
This guidance addresses the definition and regulatory status of a class of In Vitro Diagnostic Devices referred to as In Vitro Diagnostic Multivariate Index Assays (IVDMIAs). The guidance also addresses premarket pathways and postmarket requirements with respect to IVDMIAs. FDA has been aware of some confusion about the regulation of IVDMIAs that are developed by, and used in, a laboratory. FDA believes this confusion derives in part from the Agency's approach to regulation of laboratory-developed tests that use commercially available Analyte Specific Reagents (ASRs) and other commercially available, FDA-regulated components. The Agency seeks to dispel the existing confusion and clarify its approach to regulation of IVDMIAs with this guidance document.
FDA believes that IVDMIAs do not fall within the scope of laboratory-developed tests over which the Agency has generally exercised enforcement discretion. FDA believes that IVDMIAs must meet pre- and post-market device requirements under the Act and FDA regulations, including premarket review requirements in the case of class II and III devices IVDMIAs to assure the public that these tests are safe and effective.
A notice has been submitted to the Federal Register. The agency is accepting public comment for 90 days from the date of publication in the Federal Register. Comments may be sent to www.fda.gov/dockets/ecomments. Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must include the docket number (2006D-0347).
For more information see the Draft Guidance Document and the FDA’s Press Release
FTC, FDA, and CDC Issue a Public Message About the Facts on At-Home Genetic Tests
Source: Federal Trade Commission (FTC), July 2006
In a Public Message the Federal Trade Commission (FTC), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) alert the consumers about the facts surrounding the direct-to-consumers marketing of genetic tests.
According to the FDA, which regulates the manufacturers of genetic tests; and the CDC, which promotes health and quality of life, some of these tests lack scientific validity, and others provide medical results that are meaningful only in the context of a full medical evaluation. The FDA and CDC say that because of the complexities involved in both the testing and the interpretation of the results, genetic tests should be performed in a specialized laboratory, and the results should be interpreted by a doctor or trained counselor who understands the value of genetic testing for a particular situation.
Genetic tests examine genes and DNA to see if they indicate particular diseases or disorders. The results of genetic tests are not always “black and white.” That makes interpretations and explanations difficult. A negative result means that the laboratory found no unusual characteristics or changes in the genes it tested. Or it could mean that the test missed the specific genetic changes associated with a particular disease.
According to the FDA and CDC, at-home genetic tests aren’t a suitable substitute for a traditional healthcare evaluation. Medical exams that include conventional laboratory tests like blood chemistry and lipid profiles are a more appropriate starting point for diagnosing diseases and assessing preventive measures. FDA and CDC recommend that you talk to your doctor or healthcare practitioner about whether genetic test might provide useful information about your health, and if so, which test would be best. Make sure you understand the benefits and limits of any test before you buy it — or take it
For additional information on this public notice, see the entire Public Message by the FTC at: http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea02.htm
To find out whether an over the counter genetic test is FDA approved/cleared search the FDA’s Over-The-Counter tests database at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm
To find out whether a prescription genetic test is FDA approved/cleared search the in vitro diagnostic tests database at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfivd/index.cfm
FDA Seeks Volunteers to Test HL7data Interchange Standards For Submission of Product Stability Data
Source: Federal Register / Vol. 71, No. 94 / Tuesday, May 16, 2006
The Food and Drug Administration (FDA) is seeking volunteers to participate in a pilot project involving the testing of a Health Level 7 (HL7) data interchange standard for the submission of product stability data to FDA to facilitate the review of this data. Using the data interchange standards and the analytical tools will allow consistent data presentation to the agency and allow a reviewer to more efficiently and consistently display and evaluate product stability data submitted in electronic format.
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) encourages you to submit written or electronic requests to participate in the pilot project by July 17, 2006. Please submit your request for participation by mail to: Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 or electronically to: http://www.fda.gov/dockets/ecomments.
For more information on this pilot program see the Federal Register / Vol. 71, No. 94 / Tuesday, May 16, 2006
OIVD eConference: Educating IVD Manufacturers,
June 13, 2006
Source: The Office of In Vitro Diagnostic Device Evaluation and
Safety (OIVD) at the Center for Devices and Radiological Health
(CDRH) of the Food and Drug Administration (FDA), Clinical Device
Group (CDG), and the Food and Drug Law Institute (FDLI), May 4,
2006
The Office of In Vitro Diagnostic Devices at The Center for Devices
and Radiological Health (CDRH) of the Food and Drug Administration
(FDA), and the Clinical Device Group (CDG), and the Food and Drug
Law Institute (FDLI), will co-sponsor the IVD eConference: Educating
IVD Manufacturers on June 13, 2006. The objective of the eConference
is to foster communication between the professional, manufacturing
and regulatory community. This eConference provides an opportunity
to hear about the latest thinking from OIVD on best practices
for IVD development. The staff of the OIVD will discuss the study,
quality, and pre-IDE expectations for the commercialization of
new in vitro diagnostic tests.
For eConference descriptions and Registration go to
Clinical Device Group Inc. webpage.
FDA Publishes a New Guidance
Document on Using Leftover Human Specimens
Source: Office of In Vitro Diagnostic Device Evaluation
and Safety, April 25, 2006
FDA is issuing this guidance to inform sponsors, institutional
review boards (IRBs), clinical investigators, and agency staff
that the FDA intends to exercise enforcement discretion, under
certain circumstances, with respect to its current regulations
governing the requirement for informed consent when human specimens
are used for FDA-regulated in vitro diagnostic (IVD)
device investigations. As described in the document, FDA does
not intend to object to the use, without informed consent, of
leftover human specimens -- remnants of specimens collected for
routine clinical care or analysis that would otherwise have been
discarded -- in investigations that meet the criteria for exemption
from the Investigational Device Exemptions (IDE) regulation, as
long as subject privacy is protected by using only specimens that
are not individually identifiable. FDA also intends to include
in this policy specimens obtained from specimen repositories and
specimens that are leftover from specimens previously collected
for other unrelated research, as long as these specimens are not
individually identifiable.
For more information see the Guidance
Document.
FDA Publishes a New Guidance
Document for Detection of Influenza A Viruses
Source: Office of In Vitro Diagnostic Device Evaluation
and Safety, April 10, 2006
FDA is issuing this guidance to inform industry and agency staff
of recommended steps to ensure the safe and effective use of in
vitro diagnostic (IVD) devices intended for use in the detection
of influenza A (or A/B) viruses directly from human specimens.
This guidance document addresses recommendations for fulfilling
labeling requirements applicable to all IVDs intended to generally
detect influenza A (or A/B) virus directly from human specimens,
with a particular emphasis on ensuring appropriate labeling for
legally marketed influenza A (or A/B) test devices whose clearances
are not based on data addressing performance with regard to novel
influenza A viruses infecting humans (e.g., H5N1, H9N2, H7N7).
[Such devices have been classified under 21 CFR 866.3330.] This
guidance also outlines the premarket regulatory path for new or
modified devices intended to generally detect influenza A viruses,
or intended to detect and differentiate a specific novel influenza
A virus infecting humans. It also includes broad recommendations
regarding information for assessing the clinical performance and
utility of all such devices.
For more information see the Guidance
Document.
OIVD Roundtable 510(k) Workshop on
April 18-19, 2006
Source: The Office of In Vitro Diagnostic Devices at The
Center for Devices and Radiological Health (CDRH) of the Food and
Drug Administration (FDA), and the Association of Medical Diagnostics
Manufacturers (AMDM), February 14, 2006
IVD Roundtable 510(k) Workshop on April 18-19, 2006
The Office of In Vitro Diagnostic Devices at The Center for Devices
and Radiological Health (CDRH) of the Food and Drug Administration
(FDA), and the Association of Medical Diagnostics Manufacturers
(AMDM) will co-sponsor the IVD Roundtable 510(k) Workshop on April
18-19, 2006 at the Double Tree Hotel, 1750 Rockville Pike, Rockville,
MD. The objective of the IVD Roundtable 510(k) Workshop is to
foster communication between the professional, manufacturing and
regulatory community. This interactive workshop provides an opportunity
to hear about 510(k) submissions from the FDA people who actually
review the submissions. Helpful tips and guidance from experienced
industry regulatory affairs personnel will also be provided.
For more information see the Agenda
Click here to see Registration
information
FDA Publishes a New
Guidance document on Pharmacogenetic Tests and Genetic Tests for
Heritable Markers
Source: Draft Guidance for Industry and FDA Staff: Pharmacogenetic
Tests and Genetic Tests for Heritable Markers, issued on: February
9, 2006
This draft guidance document is intended to facilitate progress
in the field of pharmacogenomics and genetics by helping to shorten
development and review timelines, facilitate rapid transfer of
new technology from the research bench to the clinical diagnostic
laboratory, and encourage informed use of pharmacogenomic and
genetic diagnostic devices. It provides recommendations to sponsors
and FDA reviewers in preparing and reviewing premarket approval
applications (PMA) and premarket notification [510(k)] submissions
for pharmacogenetic and other human genetic tests, whether testing
is for single markers or for multiple markers simultaneously (multiplex
tests). Array-based tests (commonly referred to as microarrays)
are a subset of multiplex tests and are included in the scope
of this draft document. The recommendations within this draft
guidance for elements of a genetic test submission apply to pharmacogenetic
[e.g., drug-metabolizing enzyme allele tests, single nucleotide
polymorphism (SNP) analysis] and other types of genetic tests.
Tests of gene expression and tests for non-heritable (somatic)
mutations are not specifically addressed, although many of the
same principles may apply. In addition, this draft guidance considers
nucleic acid-based analysis only, but the principles may be applied
to other matrices (e.g., protein) when the purpose is to provide
genetic information.
For more information see the Guidance
Document.
New Class II Special
Controls Guidance Document for Hepatitis A Virus Serological Assays
Source: Guidance for Industry and FDA Staff Class II Special
Controls Guidance Document: Hepatitis A Virus Serological Assays,
issued on February 9, 2006
This special controls guidance document was developed to support
the reclassification of hepatitis A virus serological assays [that
detect immunoglobulin M (IgM), immunoglobulin G (IgG), or total
antibodies (IgM and IgG)] into class II. Hepatitis A virus (HAV)
serological assays are devices that consist of antigens and antisera
for the detection of HAVspecific IgM, IgG, or total antibodies
(IgM and IgG), in human serum or plasma. These devices are used
for testing specimens from individuals who have signs and symptoms
consistent with acute hepatitis to determine if an individual
has been previously infected with HAV, or as an aid to identify
HAV-susceptible individuals. The detection of these antibodies
aids in the clinical laboratory diagnosis of an acute or past
infection by HAV in conjunction with other clinical laboratory
findings. These devices are not intended for screening blood,
or solid or soft tissue donors.
For more information see the Guidance
Document.
FDA Approves the first
Avian Flu Test
Source: FDA press release, February 3, 2006.
Through use of an expedited review process, the U.S. Food and
Drug Administration was able to complete the review and approve
the Centers for Disease Control and Prevention's new test to detect
avian influenza within two weeks of the time CDC submitted its
application--an extraordinarily short timeline.
The FDA has administrative processes in place to ensure that
new medical devices, including new laboratory tests, with profound
public health importance can be prioritized and put on an accelerated
approval schedule. FDA's expedited review process is designed
to ensure that new devices that have important public health benefits
are available for use as quickly as possible.
The CDC's test, officially called the Influenza A/H5 (Asian lineage)
Virus Real-time RT-PCR Primer and Probe Set, consists of new laboratory
reagents that will help identify a specific influenza virus that
has been associated with cases of avian influenza in people from
Asia and most recently Turkey.
The elements that made this expedited review possible were preliminary
communications and intense coordination between FDA and CDC staff.
These included up-front protocol discussions between FDA and CDC
that took place in November 2005 as well as FDA's ability to review
information in real time and obtain real time responses to questions
from the CDC scientists responsible for the development of the
test.
The CDC influenza test had no precedent device but could be processed
as a 510(k) because of a regulatory process provided by Congress
in the 1997 Food Drug and Modernization Act that allows FDA to
establish safety and effectiveness of certain devices using less
burdensome regulatory procedures.
This review process highlights the flexible regulatory tools
FDA currently has that can be applied to new devices for a wide
variety of uses to ensure rapid transfer of new technology from
the research bench to clinical use.
For more details regarding the Avian Flu test see:
FDA
Approves Test to Detect Human Infection with 'H5' Avian Flu Viruses
(HHS Release, Feb. 3, 2006)
For information on Avian Flu go to FDA’s
Flu Information Page.
Class II Special Controls
Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological
Assays
Source: Guidance for Industry and FDA Staff- Class II
Special Controls Guidance Document: Herpes Simplex Virus Types 1
and 2 Serological Assays issued on: January 9, 2006.
This special controls guidance document was developed to support
the reclassification of the herpes simplex virus types 1 and 21
(HSV 1 and 2) serological assays into class II. Herpes simplex
virus serological assays are devices that consist of antigens
and antisera used in various serological tests to identify antibodies
to herpes simplex virus in serum. Additionally, some of the assays
consist of herpes simplex virus antisera conjugated with a fluorescent
dye (immunofluorescent assays) used to identify herpes simplex
virus directly from clinical specimens or tissue culture isolates
derived from clinical specimens. The identification aids in the
diagnosis of diseases caused by herpes simplex viruses and provides
epidemiological information on these diseases. Herpes simplex
viral infections range from common and mild lesions of the skin
and mucous membranes to a severe form of encephalitis (inflammation
of the brain). Neonatal herpes virus infections range from a mild
infection to a severe generalized disease with a fatal outcome.
For more information see the Guidance
Document.
FDA Reminds Healthcare Professionals
About Falsely Elevated Glucose levels
Erratum: The previously posted reminder
notice (November 3, 2005) on this subject contained incorrect information.
That is, the notice included a list of glucose measurement systems
that provide falsely elevated glucose readings in patients receiving
parenteral drug products containing maltose or galactose, or oral
d-xylose. This list included certain systems using glucose dehydrogenase
enzyme with NAD as co-factor (GDH-NAD). However, glucose measuring
systems using GDH-NAD do not exhibit interference as a result of
cross reacting sugars as described in this notice. Falsely elevated
glucose results will not be observed when using GDH-NAD systems
for patients receiving products containing the listed cross reacting
sugars. We regret any confusion the previous communication may have
caused.
Source: Food and Drug Administration, Center for Device and Radiological
Health, Office of In Vitro Diagnostic Device Evaluation and Safety,
October 31, 2005.
This notice is intended to alert physicians, nurses, medical
technologists, pharmacists and other healthcare professionals,
who perform glucose monitoring, of the potential for life-threatening
falsely elevated glucose readings in patients who have received
parenteral drug products containing maltose or galactose, or oral
xylose, and subsequently tested using glucose dehydrogenase pyrroloquinolinequinone
(GDH-PQQ) based glucose monitoring systems. The GDH-PQQ method
of glucose determination is non-specific for glucose and, in the
presence of maltose, xylose, or galactose, may yield falsely elevated
glucose readings.
For more detail see the FDA
Reminder on Falsely Elevated Glucose Readings
FDA issues a warning letter
to Tepnel Diagnostics Ltd.
Source: Office of In Vitro Diagnostic Device
Evaluation and Safety, Center for Devices and Radiological Health,
Food and Drug Administration. August 26, 2005
The Food and Drug Administration (FDA) obtained information
from Elucigene™ Brand Internet website, http://www.elucigene.com/products.html,
that Tepnel Diagnostics Ltd. is marketing the gel-based ELUCIGENE
genetic assays CF-HT, CF29, CF poly-T, CF7, Ashplex 1, Ashplex
2, Gaucher, and TRP as devices with medical and diagnostic claims
without approval or clearance from FDA, in violation of the law.
According to the Instruction for use/methods for use on Elucigene’s
website, each of the gel-based ELUCIGENE genetic assays is intended
for "in vitro diagnostic use" to detect various human
genetic mutations. In addition, a press release issued by ELUCIGENE
on March 17, 2005 claimed that, “the ELUCIGENE™ family
of kits for in vitro diagnostic use provide laboratories simple
and cost effective assays for use in genetic screening programs.
Industry-leading ELUCIGENE™ kits are available for the genetic
analysis of human diseases such as cystic fibrosis and cardiovascular
disease….”
In a Warning Letter to Tepnel Diagnostics the FDA listed the
violations by Tepnel Diagnostics and stated that Tepnel Diagnostics
should take prompt action to correct the violations and that failure
to correct the violations promptly may result in regulatory action
being initiated by the FDA without further notice.
For more information refer to the original
letter
FDA Clears Genetic Test
That Advances Personalized Medicine
Source: The Invader UGT1A1 Molecular Assay is manufactured
by Third Wave Technologies, Inc., in Madison, Wisconsin and cleared
by FDA on August 22, 2005
The Food and Drug Administration (FDA) cleared for marketing
a new blood test that will help doctors make personalized drug
treatment decisions for some patients. The Invader UGT1A1 Molecular
Assay detects variations in a gene that affects how certain drugs
are broken down and cleared by the body. Doctors can use this
information to help determine the right drug dosage for individual
patients, and minimize harmful drug reactions.
“This test represents the power of DNA-based testing to
provide individualized medical care,” said Daniel Schultz,
MD, Director of FDA’s Center for Devices and Radiological
Health. “These technologies can significantly improve patient
management and reduce the risk of ineffective or even harmful
drug therapy by telling doctors how to individualize drug dosing."
The Invader assay joins a growing list of genetic tests used
by physicians to personalize treatment decisions, including the
Roche AmpliChip, used to individualize dosage of antidepressants,
antipsychotics, beta-blockers, and some chemotherapy drugs, and
TRUGENE HIV-1 Genotyping Kit, used to detect variations in the
genome of the human immunodeficiency virus that make the virus
resistant to some anti-retroviral drugs.
The Invader assay detects variations in a gene called UGT1A1
that produces the enzyme UDP-glucuronosyltransferase. This enzyme
is active in the metabolism of certain drugs, such as irinotecan,
a drug used in colorectal cancer treatment. Variations in the
UGT1A1 gene can influence a patient’s ability to break down
irinotecan, which can lead to increased blood levels of the drug
and a higher risk of side effects. For a patient with a particular
UGT1A1 gene variation, a dose of irinotecan that is safe for another
person might be too high for this patient, raising the risk of
certain side effects. The Invader assay was studied in 66 patients
who were receiving irinotecan therapy. The study showed that persons
with one type of genetic variation have a five times greater risk
of experiencing irinotecan toxicity.
“With the growing interest in individualizing drug therapy,
FDA's approval of this assay provides physicians and patients
with important information on the proper dosage of drugs metabolized
and cleared from the body by the UGT1A1 pathway,” said Lawrence
Lesko, PhD, Director of FDA’s Office of Clinical Pharmacology
and Biopharmaceutics in the Center for Drug Evaluation and Research.
“Information on the UGT1A1 genotype can be an integral part
of drug labels and will guide health professionals on how to dose
medications such as irinotecan.”
The Invader assay is intended to aid a physician in making individualized
patient treatment decisions. It is not a substitute for a physician’s
judgment and clinical experience. Other important factors that
may affect dosing should be considered, such as the patient's
liver function (measured in part by the level of bilirubin, a
breakdown product of hemoglobin), age, kidney function, and co-administered
drugs.
FDA writes to the President of Nanogen
Corporation
Source: Office of In Vitro Diagnostic Device Evaluation
and Safety, Center for Devices and Radiological Health, Food and
Drug Administration. August 11, 2005
The Food and Drug Administration (FDA) obtained information
from Nanogen Corporation’s website at http://www.nanogen.com/products,
that Nanogen Corporation is marketing NanoChip® Molecular
Biology Workstation and NanoChip® Electronic Microarray as
analyte specific reagents (ASRs). Nanogen's website indicates
that it also offers reagents "predefined" for use with
the NanoChip Molecular Biology Workstation, including an ApoE
device, ASPA device, HFE device, and FactorV/Prothrombin device.
In a letter to the President of the Nanogen Corporation the FDA
listed the violations by Nanogen Corporation and requested that
they respond within thirty (30) days of receipt of the letter
and encouraged them to meet with the FDA to discuss the NanoChip®
Molecular Biology Workstation, NanoChip® Electronic Microarray
and their other devices marketed as ASRs.
For more information refer to the original
letter
In a Warning Letter to the President
of Access Genetics FDA stated that several genetic tests manufactured
by the firm are not in conformance with the Federal Food, Drug and
Cosmetic Act.
Source: Office of In Vitro Diagnostic Device Evaluation
and Safety, Center for Devices and Radiological Health, Food and
Drug Administration. August 1, 2005
The Food and Drug Administration (FDA) obtained information from
Access Geneticist’s website at http://www.access-genetics.com,
that Access Genetics is marketing several genetic tests including
Thrombophilia Tests (Factor 5 Leiden, Factor 2 Prothrombin, MTHFR),
Human Papillomavirus (HPV), Chlamydia & Gonorrhea PAP and
Cystic Fibrosis as devices with medical and diagnostic claims
without approval or clearance from FDA, in violation of the law.
According to the website “Each Test Package contains all
the consumables, reagents and controls needed to perform the DNA
extraction and chemistry for CT-NG PAP tests. It includes a Lab
Assay Protocol and custom process templates that guide remote
laboratory technicians in preparing and sending test assay results
to Access Genetics' pathologists.”
In a Warning Letter to the President of the Access Genetics the
FDA listed the violations by Access Genetics and stated that Access
Genetics should take prompt action to correct the violations and
that failure to correct the violations promptly may result in
regulatory action being initiated by the FDA without further notice.
For more information refer to the original
letter
OIVD Holds Immunology Devices Panel
Meeting to Discuss Approval of the Nymox Urine Neural Thread Protein
(NTP) Test as an Aid in Diagnosis of Alzheimer’s Disease
Source: Advisory Committee Coordinator, Center for Devices and Radiological
Health, Food and Drug Administration. July 15, 2005
The FDA’s Immunology Devices Advisory Committee held an
open public meeting on Jul 15, 2005 from 8:30 AM - 5:00 PM at
the Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg,
MD.
The committee heard a presentation on the FDA Critical Path Initiative
and a presentation by the Office of Surveillance and Biometrics
in the Center for Devices and Radiological Health outlining their
responsibility for the review of postmarket study design. The
committee discussed and made recommendations and voted on a premarket
approval application for a laboratory assay designed to measure
levels of neural thread protein in urine specimens from patients
presenting with cognitive complaints or other signs and symptoms
of suspected Alzheimer’s disease. Results from this test
are intended for use, in conjunction with and not in lieu of current
standard diagnostic procedures, to aid the physician in the differential
diagnosis of Alzheimer’s disease. The advisory committee
voted to decline approval by a vote of five to two.
For more information, please go to the Panel
Meeting page
FDA Issues a Public
Message Regarding Drugs of Abuse Tests
Source: FDA, June 13, 2005
In a Public Message the FDA stated that they are working to address
consumer confusion about tests used by businesses and consumers
that are intended to screen for drugs of abuse like cocaine, marijuana,
opiates, PCP, or methamphetamine.
FDA has regulations that address premarket review of these screening
tests. FDA review of screening tests intended to detect the presence
of a drug of abuse involves an evaluation of both performance
data and labeling. FDA reviews performance data to assure that
in the hands of the intended user (whether a laboratory worker,
a trained non-laboratory health care worker, or a lay user) the
assay meets current standards for accuracy and reliability. FDA
reviews proposed labeling to help assure that intended users can
understand the instructions for use and that the labeling conveys
other important information, including the importance of confirmatory
testing when the results of the screening test are positive.
For additional information on this public notice, see the
entire Public Message by the FDA.
To find out whether an over the counter drug of abuse test is
FDA approved/cleared search the FDA’s Over-The-Counter tests
database at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm
To find out whether a prescription drug of abuse test is FDA
approved/cleared search the in vitro diagnostic tests database
at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfivd/index.cfm
FDA Issues a Public Message on LifeScan
Blood Glucose Meters
Source: Office of In Vitro Diagnostic Device Evaluation and Safety,
CDRH, FDA, June 13, 2005
In a Public Message the FDA stated that LifeScan has notified
users of some of the company's blood glucose monitoring systems
that it may be possible for them to misinterpret their blood glucose
test results if their meter is set incorrectly. The affected meters
are the OneTouch® Ultra®, the OneTouch® FastTake®
and the InDuo® Systems.
These meters were originally designed to allow the patient to
select one of two units of measure to display their blood glucose
results: milligrams per deciliter (mg/dL), the standard used in
the U.S., and millimoles per liter (mmol/L), which is used in
many other countries. This feature allows patients to see their
test results in the units customarily used in their own country.
Meters with this same feature are also made by other companies.
LifeScan found that it was possible for patients, in the course
of setting the meter’s date and time, to accidentally change
the unit of measure. If the meter is in the wrong units of measure
and the patient looks only at the result registered on the meter,
without reading the measurement unit displayed next to the result,
he or she could misunderstand the test result. This could lead
to the patient managing his or her diet or medication in a way
that could result in temporary periods of high or low blood sugar,
which may require medical intervention.
For additional information on this public notice, see the entire
Public Message by the FDA.
In a Warning Letter to the President
of BioImagene, Inc. of San Jose California FDA stated that the PATHIAM
“a hardware-independent, Web-enabled software” is not
in conformance with the Federal Food, Drug and Cosmetic Act.
Source: Office of In Vitro Diagnostic Device Evaluation
and Safety, Center for Devices and Radiological Health, Food and
Drug Administration. May 25, 2005
The Food and Drug Administration (FDA) obtained information
from BioImagene’s
website at http://www.bioimagene.com,
that BioImagene is marketing PATHIAM as a device with medical
and diagnostic claims without approval or clearance from FDA,
in violation of the law. According to the website PATHIAM is “an
intelligent image analysis software system designed to fulfill
the needs of objective analysis of oncopathology images”.
In a Warning Letter to the President of the BioImagene Inc the
FDA listed the violations by BioImagene and stated that BioImagene
should take prompt action to correct the violations and that failure
to correct the violations promptly may result in regulatory action
being initiated by the FDA without further notice.
For more information refer to the original
letter
Class
I Recall: BioMerieux Simplastin HTF Tissue Reagent
Source: FDA Medical Device Recalls, March 7, 2005
BioMerieux initiated a recall because mislabeling problems with
certain lots of this product could result in inaccurate test results,
which in turn could lead to improper patient treatment –
in some cases resulting in serious or life-threatening injury.
Although BioMerieux initiated a recall of these products in
March 2005, its notifications to purchasers incorrectly indicated
that the problem was of no clinical significance. The company
is now clearly informing its customers about the importance of
this problem and the need to respond to it. BioMerieux is notifying
its distributors and subsidiaries by Field Corrective Action communication
and has notified all customers individually about the change in
the recall’s status.
Customers with questions may contact BioMerieux at 1-800-682-2666
or they may contact their local BioMerieux customer representative.
Patients or healthcare providers with concerns can also call the
company at the 800 number listed.
For additional information on this product recall, see the FDA’s
Medical Device Recalls at http://www.fda.gov/cdrh/recalls/recall-030705.html
Or the company press release at: http://www.fda.gov/oc/po/firmrecalls/biomerieux05_05.html
Class I Recall: LifeScan, Inc.
Blood Glucose Meters
Source: Medical Device Recalls, April 11, 2005
LifeScan blood glucose meters the OneTouch® Ultra®, InDuo®
and the OneTouch® FastTake® are distributed primarily
through retail pharmacy and mail order channels. Blood glucose
meters are used by diabetes patients to measure the amount of
glucose in their blood, and as an aid to monitor the effectiveness
of diabetes management in the home or clinical setting. From the
beginning of 2004 through mid-March 2005, LifeScan, Inc., has
received 40 worldwide reports of adverse events associated with
these meters being set to the incorrect unit of measure. Incorrect
measurement settings may result in users misinterpreting their
blood glucose results. All three affected meter systems were originally
designed to allow patients to select one of two standard units
of measure to display their test results. This selection is typically
determined by the standard used by the country in which they live.
LifeScan, Inc., found that it was possible for consumers, in the
course of setting their meter’s date and time, to accidentally
change the unit of measure and thereby misinterpret their blood
glucose results. In addition, very rarely, an event such as dropping
a meter while in use can cause a brief power loss, which may also
unexpectedly change the unit of measure and/or the code number
used to program the meter to match a particular vial of test strips.
Patients with affected glucose meters are advised to contact
LifeScan, Inc., to confirm their meter is set to the proper unit
of measure.
For additional information on this product recall, see Medical
Device Recalls at: http://www.fda.gov/cdrh/recalls/recall-041105.html),
the FDA Firm Safety Alert at http://www.fda.gov/oc/po/firmrecalls/lifescan04_05.html,
or the company’s press release at http://www.lifescan.com/company/about/press/ultra_uom/
FDA Approves First DNA-based
Test to Detect Cystic Fibrosis
Source: The Tag-It Cystic Fibrosis Kit is manufactured
by Tm Bioscience Corporation of Toronto, Canada and approved by
FDA on May 9, 2005
The Food and Drug Administration (FDA) approved the first DNA-based
blood test to help detect cystic fibrosis. The Tag-It Cystic Fibrosis
Kit directly analyzes human DNA to find genetic variations indicative
of the disease. The test will be used to help diagnose cystic
fibrosis in children and to identify adults who are “carriers”
of the gene variations.
“This test represents a significant advance in the application
of genetic technology and paves the way for similar genetic diagnostic
tests to be developed in the future,” said Daniel Schultz,
MD, director of FDA’s Center for Devices and Radiological
Health.
Cystic fibrosis is a serious genetic disorder affecting the lungs
and other organs that often leads to an early death. It is the
number one cause of chronic lung disease in children and young
adults, as well as the most common fatal hereditary disorder affecting
Caucasians in the United States. The disease affects about one
in 2500-3300 Caucasian babies. Half of the people with cystic
fibrosis die by the age of 30.
The Tag-It test identifies a group of variations in a gene called
the “cystic fibrosis transmembrane conductance regulator”
or CFTR gene that causes cystic fibrosis. FDA approved Tag-It
based on a manufacturer study of hundreds of DNA samples showing
that the test identifies the CFTR gene variations with a high
degree of certainty. The manufacturer also provided FDA with a
broad range of supporting peer-reviewed literature.
Since Tag-It detects a limited number of the more than 1300 genetic
variations identified in the CFTR gene, the test should not be
used alone to diagnose cystic fibrosis. Physicians should interpret
test results in the context of the patient’s clinical condition,
ethnicity, and family history. Also, patients may need genetic
counseling to help them understand their test results.
The Tag-It Cystic Fibrosis Kit is manufactured by Tm Bioscience
Corporation of Toronto, Canada.
In a letter to the CEO of Agendia
B.V. of The Netherlands, FDA expressed concern that the MammaPrint®
diagnostic test may not be in conformance with the Federal Food,
Drug and Cosmetic Act.
Source: Office of In Vitro Diagnostic Device Evaluation
and Safety, Center for Devices and Radiological Health, Food and
Drug Administration. April 6, 2005
The Food and Drug Administration (FDA) obtained information from
Agendia B.V.’s website at www.agendia.com, and from the
Agendia B.V.’s December 8, 2004 press release that Agendia
B.V. intends to distribute the MammaPrint® diagnostic test
in the U.S. In a letter to the CEO of the Agendia B.V. the FDA
raised concern that the MammaPrint® diagnostic test may not
be in conformance with the Federal Food, Drug and Cosmetic Act,
including the requirements related to marketing clearance or approval.
In this letter the FDA invited the Agendia B.V. to meet with the
FDA at their earliest convenience to discuss the proper regulation
of the MammaPrint®.
For more information refer to the original
letter.
Class I Recall:
MicroScan® Rapid Pos Inoculum Broth
Source: Medical Device Recalls, February 7, 2005
MicroScan® Rapid Pos Inoculum Broth is used to inoculate
MicroScan® Rapid Fluorogenic Gram Positive MIC/BP panels,
which are intended for the determination of antimicrobial susceptibility
of gram-positive organisms. The test results for the MicroScan®
Rapid Fluorogenic Gram Positive MIC/BP panels are provided in
3.5 to 15 hours as opposed to greater than 16 hours for the MicroScan®
Dried overnight Gram positive panels.
Dade Behring initiated a product recall to prevent health risk
to patients due to potential false antibiotic susceptibility results.
The possibility of inaccurate susceptibility results for a pathogen
could lead a physician to prescribe incorrect or suboptimal therapy.
Customers with questions may contact the Dade Behring MicroScan
technical assistance center at 1-800-677-7226.
For more information, see FDA’s
medical device recalls.
The Industry
Evaluated OIVD on Their Performance in Premarket Review
Source: OIVD FY 2004 Premarket Customer Perception Survey
Results, April 2005
The Office of Management and Operations, Division of Planning,
Analysis, and Finance, Analysis Branch conducted a survey to obtain
industry feedback on the premarket review process at OIVD to help
OIVD gauge how customers perceive the device review process, to
identify areas that may need improvement, and finally to use results
in the 2005 Performance Scorecard Key Indicator “Knowledge
Mgmt and Stakeholder Collaboration.”
A random sample of industry contacts was selected from the FY
2004 premarket applications with final decisions. The sample was
proportionally allocated within each Office by application types
and respondents were contacted by telephone.
See the result of
the survey for more information.
FDA Release
the Drug-Diagnostic Co-Development Concept Paper in Preparation
for Guidance Development
Source: Preliminary concept paper on drug-diagnostic co-development,
April 2005.
This concept paper reflects preliminary Agency thoughts on how
to prospectively co-develop a drug or biological therapy (drugs)
and device test in a scientifically robust and efficient way.
The thoughts and recommendations contained here are being put
forward for discussion purposes only. The Agency intends to solicit
initial input from the public on this concept paper, and then
develop a draft guidance for public comment according to the good
guidance practices regulation (21 CFR 10.115).
Comments to the Drug Diagnostic Co-development Concept Paper
can be sent to Docket# 2004N-0279. Comments and suggestions regarding
this draft concept paper should be submitted within 90 days of
publication of the concept paper. Submit comments to the Division
of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments
should be identified with the docket number listed above.
See the Concept
Paper for more information.
Nationwide Alert On B-Sure Pregnancy
Test
Source: Oak Park, MI -- March 25, 2005 -- Harmony Brands,
Oak Park, Michigan, a national distributor of health, cosmetic and
other consumer products, is voluntarily recalling its B-Sure brand
One-Step Home Pregnancy Test., because its safety and efficacy can
no longer be assured.
Consumers who have unused & unexpired B-Sure brand One-Step
Home Pregnancy Test in their possession should not use the product
and should return the product to the point of purchase for a refund.
Additionally, women who have used the test may wish to contact
their health care provider to verify the test results.
For more information see the Firm
Press Release
New Class II Special Controls
Guidance Document for Automated Fluorescence in situ Hybridization
(FISH) Enumeration Systems
Source: Guidance for Industry and FDA Staff-Class II Special Controls
Guidance Document: Automated Fluorescence in situ Hybridization
(FISH) Enumeration Systems, issued on: March 23, 2005
This guidance document was developed as a special controls guidance
to support the classification of automated fluorescence in situ
hybridization (FISH) enumeration systems into class II (special
controls). An automated FISH enumeration system is a device consisting
of an automated scanning microscope and image analysis system
designed to detect and enumerate FISH signals in interphase nuclei
of formalin-fixed, paraffin-embedded human tissue specimens. The
systems also contain common hardware and software platforms with
customized software applications for FISH assays. Automated FISH
enumeration systems are intended for in vitro diagnostic use with
FISH assays as an aid in the detection, counting, and classification
of cells based on recognition of cellular color, size, and shape.
The use of automated systems may reduce hands-on time compared
to manual enumeration of FISH assays.
For more information see the Guidance Document and the Federal
Register notice.
Federal register notice for this guidance document (PDF)
(
HTML)
Guidance Document (PDF)
( HTML)
New Class II Special Controls Guidance Document for Drug
Metabolizing Enzyme Genotyping System
Source: Guidance for Industry and FDA Staff-Class II Special
Controls Guidance Document: Drug Metabolizing Enzyme Genotyping
System, issued March 10, 2005
This document was developed as a special control to support the
classification of drug metabolizing enzyme (DME) genotyping systems
into class II (special controls). A DME genotyping system is a
device intended for use in testing DNA to identify the presence
or absence of human genotypic markers encoding a drug metabolizing
enzyme. This device is used as an aid in determining treatment
choice and individualizing treatment dose for therapeutics that
are metabolized primarily by the specific enzyme about which the
system provides genotypic information.
For more information see the Guidance Document and the Federal
Register notices.
Guidance document (PDF)
(HTML)
Federal notice for this guidance document (PDF)
(HTML)
Final rule for this guidance document (PDF)
(HTML)
New Class II Special Controls Guidance Document for Instrumentation
for Clinical Multiplex Test Systems
Source: Guidance for Industry and FDA Staff-Class II Special Controls
Guidance Document: Instrumentation for Clinical Multiplex Test Systems,
issued March 10, 2005
This guidance document was developed as a special controls guidance
to support the classification of instrumentation for clinical
multiplex test systems into class II (special controls). This
type of device is intended to measure and sort multiple signals
generated by an assay from a clinical sample. This instrumentation
is used with a specific assay to measure multiple similar analytes
that establish a single indicator to aid in diagnosis. Such instrumentation
may be compatible with more than one specific assay. The device
includes a signal reader unit, and may also integrate reagent
handling, hybridization, washing, dedicated instrument control,
and other hardware components, as well as raw data storage mechanisms,
data acquisition software, and software to process detected signals.
For more information see the Guidance Document and the Federal
Register notice.
Guidance document (PDF)
(HTML)
Federal notice for this guidance document (PDF)
(HTML)
Final rule for this guidance document (HTML)
The UroVysion™ Bladder Cancer Test Approved
Source: UroVysion™ Bladder Cancer Kit manufactured by Vysis,
Inc. (a wholly-owned subsidiary of Abbott Laboratories) and approved
by FDA on January 24, 2005
A brief overview of information related to FDA's approval to
market this product is
available here.
Roche AmpliChip Cytochrome P450 Genotyping Test and Affymetrix
GeneChip Microarray Instrumentation System Cleared
Source: Roche AmpliChip Cytochrome P450 Genotyping test and Affymetrix
GeneChip Microarray Instrumentation System manufactured by Roche Molecular
Systems, Inc.and Affymetrix, Inc; cleared December 23, 2004.
A brief overview of information related to FDA's clearance to
market this product is
available here.
FDA Extends Pilot Program for Evaluation of Globally Harmonized
Medical Device Premarket Applications Until July 2006 (The STED
Initiative)
Source: The Center for Devices and Radiological Health
(CDRH), Food and Drug Administration (FDA), is reminding device
manufacturers of its pilot program for submitting premarket applications
(premarket notifications (510(k)s) and premarket approval applications
(PMAs)) in a globally harmonized format. FDA initiated this program
in June 2003 and will accept submissions in this format until July
2006.
Under this program, FDA is permitting manufacturers to submit
certain 510(k)s and PMAs in a Summary Technical Document (STED)
format. The STED format for regulatory submissions is a harmonized
submission format developed by the Global Harmonization Task Force
(GHTF), a voluntary partnership of government and industry representatives
from the United States of America and four other member states.
GHTF promotes international harmonization of medical device regulation
through the preparation and distribution of guidelines such as
the proposed STED format. The STED harmonized submission format
is accepted by multiple regulatory authorities worldwide. While
the use of the STED format is still in its early stages, it has
the long-term potential to standardize the format of regulatory
submissions across jurisdictions.
FDA is encouraging medical device manufacturers to participate
in the STED pilot program. Manufacturers will benefit from exposure
to the STED preparation process, especially those seeking international
regulatory approval/clearance for their devices. In addition,
greater industry participation in this program will increase FDA’s
familiarity with STED submissions and will allow FDA to provide
constructive feedback to GHTF on the current STED format.
If you would like to submit a premarket application in the STED
format, please consult FDA’s Guidance on the STED pilot
program. This can be found on the World Wide Web at http://www.fda.gov/cdrh/ode/guidance/1347.html.
Additional guidance for STED preparation can be found on the GHTF
web site at http://www.ghtf.org/sg1/sg1-proposed.html.
For further information and background on FDA’s STED pilot
program, please contact Harry R. Sauberman, P.E., at (301) 443-8879,
ext. 148, or Kenneth J. Cavanaugh, Ph.D., at (301) 443-8517, ext.
170.
FDA Warns Consumers Not to Use Home-Use Diagnostic Kits
Marketed by Globus Media
Source: The Food and Drug Administration (FDA) is warning
consumers not to use unapproved home-use diagnostic test kits that
have been marketed nationwide via the Internet by Globus Media,
Montreal , Canada.
The use of these products could result in false results that
could lead to significant adverse health consequences. The illegal
kits are labeled as:
- Rapid HIV Test Kit
- Rapid Syphilis Test Kit
- One Step Cassette Style Cocaine Test
- One Step Cassette Style Marijuana (THC) Test
- One Step Cassette Style Amphetamine Test
- Rapid Dengue Fever Test
- One Step Midstream Style HCG Urine (Home)
- Pregnancy Test
FDA learned of the problem from two consumer complaints.
FDA has not approved or evaluated the performance of any of
Globus Media's products. As a result, consumers cannot know with
any degree of certainty that test results are correct. For example,
a person testing positive for HIV (human immunodeficiency virus,
or the AIDS virus) using one of these tests may not be infected
with HIV, or, worse, someone infected with HIV may test negative
and not seek medical treatment or spread the virus to others.
The tests were sold through websites and distributed throughout
the U.S. , usually by overnight delivery services. These have
been made available for sale on several websites, including www.htkit.com
and www.hstkits.com. The kits usually are contained in a paper
envelope with instructions inside the packaging. The envelope,
instructions and packaging may not accurately identify the manufacturer,
packer or distributor. The name of the kit appears on the instructions.
Consumers who have these products should not use them. Anyone
who has used one of these test kits should be retested using valid
test methods. Only one HIV home collection test system is approved
by FDA and legally sold in the United States . This test, sold
as either "The Home Access HIV-1 Test System" or "The
Home Access Express HIV-1 Test System" is manufactured by
Home Access Health Corporation and allows blood samples to be
taken at home which people then send to a laboratory for testing.
No home-use test kits intended for diagnosing syphilis and dengue
fever are approved for sale in the U.S.
The FDA has issued an import alert which alerts FDA field personnel
to the possible importation of the Globus Media devices, provides
guidance as to their detention and refusal of admission into the
U.S. , and also advises U.S. Customs officials about these products.
Class 1 Recall: Tosoh Bioscience AIA-600 II Analyzers
Source: Medical Device Recall, Tosoh Bioscience AIA-600 II Enzyme
Immunoassay Analyzer, software version 3.02. April 2, 2003, However,
FDA first learned of this problem during an inspection of the firm
during August - September 2004.
AIA-600 II Enzyme Immunoassay Analyzer is used by laboratory
professionals to measure thyroid hormones, cardiac markers including
troponin, tumor markers, as well as several other assays. The
amalyzer with software version 3.02 was recalled because it produced
occurrence of false positive and false negative results which
could lead to aggravation of the patient’s clinical condition,
delay in treatment and potentially death. Patients with small
myocardial infarctions are particularly at risk of being negatively
affected by false troponin test results. The firm developed a
software upgrade but the corrective action was not adequate because
the firm did not contact users alerting them of the problem nor
did the firm describe how the problems could be corrected.
For additional information on this product recall, see the TOSOH
Bioscience, Inc. press release and FDA’s
Medical device recalls
New Class II Special Controls Guidance for Newborn Screening
Test Systems Using Tandem Mass Spectrometry
Source: Guidance for Industry and FDA Staff, Class II Special Controls
Guidance Document: Newborn Screening Test Systems for Amino Acids,
Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry,
November 24, 2004
This guidance document was developed as a special controls guidance
to support the classification of newborn screening test systems
for amino acids, free carnitine, and acylcarnitines using tandem
mass spectrometry into class II (special controls). These devices
are intended for the measurement and evaluation of amino acids,
free carnitine, and acylcarnitine concentrations from newborn
whole blood filter paper samples. Quantitative analysis of amino
acids, free carnitine, and acylcarnitines and their relationship
with each other provides analyte concentration profiles that may
aid in the screening of newborns for one or more inborn errors
of amino acid, free carnitine, and acylcarnitine metabolism. This
document addresses premarket submissions for newborn screening
purposes only; it does not address premarket submissions for confirmatory
or pre-natal screening purposes.
For more information see the Guidance Document [PDF]
[Text]
and the Federal Register notice [PDF]
[Text]
New Guidance on Use of Symbols on Labels and in Labeling
of In Vitro Diagnostic Devices
Source: Guidance for Industry and FDA Staff, Use of Symbols on Labels
and in Labeling of In Vitro Diagnostic Devices Intended for Professional
Use. November 30, 2004
This document provides guidance on the use of selected symbols
in place of text to convey some of the information required for
in vitro diagnostic devices (IVDs) intended for professional use
by 21 CFR 809.10, FDA’s labeling requirements for in vitro
diagnostic devices, and 21 CFR parts 610 and 660, FDA’s
labeling requirements for biologics (including IVDs) that are
licensed under the Public Health Service (PHS) Act. These recommendations
apply to the use of symbols on the labels and in labeling only
of IVDs intended for professional use, and not for over-the-counter
or prescription home-use IVDs. This guidance does not address
the use of “unique and generally recognized” symbols
to identify the manufacturer of a device, as described in Section
502(u) of the Food, Drug and Cosmetic Act.
For more information see the Guidance Document [PDF]
[Text]
CLSI will conduct an Eqivalent QC Workshop in conjunction
with the 2005 Leadership Conference
Source: Eqivalent Quality Control Workshop on March 18th, 2005 held
in conjunction with the Clinical and Laboratory Standards Institute’s
(formerly NCCLS) 2005 Leadership Conference at the Renaissance Harborplace
Hotel, Baltimore, Maryland March 16-19, 2005
This workshop has been organized and will be presented by experts
from AACC, ACLA, AdvaMed, AMT, ASCLS, ASCP, ASM, CDC, CMS, FDA,
CAP, CLMA and Clinical and Laboratory Standards Institute (formerly
NCCLS). This one-day workshop is intended for technical and management
laboratory personnel, IVD industry epresentatives and government
staff. The attendees will learn about the current and future technology
of QC; experience contributing to the future of QC; Network with
colleagues; and participate in discussion and breakout groups.
Following the workshop a report entitled “Clinical and Laboratory
Standards Institute consensus guidelines with QC mechanisms and
a plan for future QC” will be available.
For registration and more information on the workshop go to the
NCCLS Leadership Conference Program
[in WORD]
For the workshop’s agenda go to the NCCLS
Leadership Conference Agenda [in WORD]
For the PowerPoint presentations go to the CLSI
webpage.
FDA and CMS invite the CEOs of Laboratory Corp. of America
and Quest Diagnostics to discuss the nature and appropriate regulatory
status of the OvaCheck - Ovarian Cancer Screen Test
March 5, 2004
In a letter to the Chairman and CEO of the Laboratory Corporation
of America and a letter to the CEO of Quest Diagnostics, the Food
and Drug Administration and Centers for Medicare and Medicaid
Services stated that the markting status of the OvaCheck, a new
test for ovarian cancer screening, is unclear. The two agencies
have invited each of these laboratories to come in for discussion
of whether this new assay would be subject to regulation only
by CMS, under the Clinical Laboratories Improvement Amendments
of 1988 (CLIA '88), or whether it may also require premarket review
by FDA under the Federal Food, Drug, and Cosmetic Act. Both agencies
are anxious to work with the involved stakeholders to ensure a
properly validated test is rapidly available to the medical marketplace.
For more information see: Quest
Diagnostics Letter and Lab
Corporation of American Letter
FDA Clears the West Nile Virus IgM Capture ELISA and the
West Nile Virus ELISA IgG Tests Manufactured by Focus Technologies.
(November 13, 2003)
On October 22, 2003 the Food and Drug Administration (FDA) approved
two more tests for use as an aid in the clinical laboratory diagnosis
of West Nile Virus infection. The two tests, the West Nile Virus
IgM Capture ELISA and the West Nile Virus ELISA IgG are serological
assays made by Focus Technologies in Cypress, California. They
are intended for use in patients with clinical signs and symptoms
consistent with meningioencephalitis. To see the Decision Summary
for these tests go to K031952
and K031953
The disease caused by West Nile virus first appeared in 1999
in New York City. Since then the West Nile virus has spread rapidly
across the United States with 44 states reporting over 7000 human
cases to the CDC for the year 2003.
West Nile virus is a flavivirus that is transmitted to humans
by mosquito bites. Most people who are infected with West Nile
virus (WNV) will not have any type of illness. Experts estimate
that 20% of the people who become infected will develop West Nile
fever: mild symptoms, including fever, headache, and body aches,
occasionally with a skin rash on the trunk of the body and swollen
lymph glands. The most serious manifestation of this disease is
meningitis or encephalitis (inflammation of the brain). Encephalitis
occurs in less than 1% of those infected, causing severe neurological
disease and even death.
The Focus West Nile Virus IgM and IgG assays were evaluated using
over 1000 retrospective and prospectively collected patient sera,
which were tested at four different clinical sites. When compared
to the reference testing methods (Plaque-Reduction Neutralization
Test or the CDC ELISA assays) the serological performance was
satisfactory. Overall agreement rates with the reference methods
for the Focus IgM assay was 97.3% and 92.7% for the Focus IgG
assay. The sensitivities and specificities varied depending on
the populations studied and the comparative methods used.
While the test is an aid in diagnosis of West Nile virus, there
is extensive cross-reactivity with other known flavivirus including
St. Louis encephalitis virus, and dengue virus. Some significant
cross-reactivity has been noted with the Focus IgG assay and antibodies
from other agents such as cytomegalovirus and La Crosse virus
and rheumatoid factor sometimes cross-reacted with the Focus IgM
assay. Positive results therefore are presumptive and must be
confirmed by Plaque Reduction Neutralization Test (PRNT), or by
using the current CDC guidelines for diagnosis of this disease
IgM antibodies to West Nile virus usually can be detected within
the first 1 to 8 days after onset of overt disease and can assist
in the diagnosis of these patients. IgG antibodies to West Nile
are detected a little later and persist longer than IgM antibodies.
The results from the Focus West Nile Virus IgM and IgG assays,
when used in conjunction, may be able to distinguish a past West
Nile virus or flavivirus infection from a current or recent infection.
These two tests will contribute in helping to identify and deal
with the growing public health problem concerning human infection
with the West Nile virus.
FDA Recognizes Two New IVD Standards Developed by NCCLS
- The MM7-A and M33-A.
(November 13, 2003)
FDA recognized the following two standards developed by the National
Committee for Clinical Laboratory Standards.
NCCLS, MM7-A, Fluorescence In Situ Hybridization (FISH) Methods
for Medical Genetics; Approved Guideline
NCCLS, M33-A, Antiviral Susceptibility Testing: Herpes Simplex
Virus by Plaque Reduction Assay; Approved Standard
FDA Releases Draft Guidance Document on “Use of Symbols
on Labels and in Labeling of In Vitro Diagnostic Devices Intended
for Professional Use"
(November 4, 2003)
The 10/28/03 Federal Register announced the availability of the
draft guidance entitled "Use of Symbols on Labels and in
Labeling of In Vitro Diagnostic Devices Intended for Professional
Use". You can view this document at: http://www.fda.gov/cdrh/ocd/guidance/4444.html
This document provides guidance on the use of selected symbols
in place of text to convey some of the information required for
IVDs intended for professional use by FDA's labeling requirements
for IVDs.
FDA Releases Class II Special Controls Guidance Document
for “Serological Reagents for the Laboratory Diagnosis of
West Nile Virus''
(November 4, 2003)
The 10/30/03 Federal Register announced classification of the
West Nile Virus IgM Capture Elisa assay. The Agency is classifying
this device into class II (special controls) in order to provide
a reasonable assurance of safety and effectiveness of the device.
You can view this document at: http://www.fda.gov/cdrh/oivd/guidance/1206.html
FDA Releases Class II Special Controls Guidance Document
for “Endotoxin Assay"
(November 4, 2003)
The 10/31/03 Federal Register announced classification of the
Endotoxin Assay. The Agency is classifying this device into class
II (special controls) in order to provide a reasonable assurance
of safety and effectiveness of the device.
You can view this document at: http://www.fda.gov/cdrh/oivd/guidance/1222.html
Misys Healthcare Issues Domestic and International Recall
of Misys Laboratory, a Laboratory Information System Software Device
(October 22, 2003)
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
October 10, 2003
Misys Healthcare Systems of Tucson, Ariz., is initiating a domestic
and international recall of the Misys Laboratory software version
5.3. Version 5.3 of the software has demonstrated a defect could
result when the information systems uses 3 specific functions
together,i.e. Rapid Order, Calculations, and Autofiling. The use
of the defective laboratory information system software could
result in the release of laboratory test reports without quality
assurance validation and without abnormal results flags for critical
values and abnormal results. To date no injuries have been reported
in connection with this problem. FDA has been made aware of the
recall and is working with the company.
The recalled products have been distributed to health care facilities
throughout the world. Misys Healthcare Systems is notifying its
customers and strongly advising that the health care institutions
using this product request the individual code correction package
B-AUT-RAPID-LAB as soon as possible.
Such requests should be made to the Misys Client Advocate at
1-877-239-6337. European clients may call 44 (0) 161 335 0562.
OIVD is posting on this web page a Summary of how Decisions
were made to clear a 510(k) submission
(October 3, 2003)
Consistent with CDRH’s center-wide “Knowledge Management”
and “Transparency” initiatives, the Office of In Vitro
Diagnostic Device Evaluation and Safety (OIVD) has implemented
the use of a standardized Decision Summary Template in which,
at a glance, one can understand the basis for clearance of a particular
510(k) submission. This program has been in place since August
1, 2003.
To see these Decision Summaries for all 510(k) clearances since
August 1, 2003, go to the following link from the OIVD home page:
Cleared/Approved
OIVD Products Since 8/1/2003
Roche Diagnostics Recalls All CoaguChek PT Test Strips
Currently in the Marketplace
(September 30, 2003)
National recall notice on medical device used to determine
blood clotting time (issued September 26, 2003)
Roche Diagnostics is notifying users of an important recall
of all CoaguChek PT test strips currently in the market place
because of the potential for a packaging defect that will cause
false results.
CoaguChek PT test strips are used by patients in the home and
by professionals in medical settings to determine blood clotting
time of patients taking anti-coagulants, also known as blood thinners,
and to diagnose some disease conditions. Incorrect results may
have serious or life threatening consequences because patients
may be improperly diagnosed or improperly treated. Blood thinners
are used to treat patients with a potential for blood clots. For
example, patients with heart valve replacement, certain types
of heart disease or blood clots in their legs.
Roche has determined that some of the foil pouches in which the
test strips are packaged were improperly sealed allowing moisture
and air to enter the pouch. These products give false results
when exposed to moisture for more than a few minutes. Home users
should contact their health care professional for further advice
and instructions.
Roche Diagnostics is notifying all home users and health care
professionals who use the product to inspect the foil pouch prior
to use and to perform duplicate testing for all lots until further
notice. The problem is the perforation and the “easy open”
notches are not properly centered between the pouches. Users must
inspect each pouch prior to use, not use any strips from that
box if they see a defect, and run two test strips each time they
test in case they fail to visually detect the defect.
Investigations reveal that only a small percentage of the strips
are affected. There have been no reports of illnesses or injuries
resulting from a pouch defect.
Letters are being sent to customers, providers, and physicians,
informing them of this voluntary action. Additional information,
including a photograph of the defective pouch, will be posted
on Roche Diagnostics’ U.S. CoaguChek Web site at: http://www.coaguchek-usa.com.
US customers with immediate concerns, or interested in details
of this recall, can call Roche Diagnostics Point of Care Technical
Service at: 1-800-428-4674.
Roche Diagnostics has implemented corrective actions to resolve
this issue. This action is being taken by Roche Diagnostics with
the knowledge of the U.S. Food and Drug Administration.
For more information contact:
Lori LeRoy |
Joel Reuter |
Roche Diagnostics Corporation |
Roche Diagnostics Corporation |
317-521-7159 |
317-521-7431 |
Lori.leroy@roche.com |
Joel.reuter@roche.com |
ISO 15197 standard recognized for use in evaluating performance
for home glucose meters
(July 15, 2003)
ISO (the International Organization for Standardization) 15197
standard has recently been recognized for use in evaluating performance
for home glucose meters. This standard sets up a protocol
for performance measurement and also defines error limits.
While FDA plans to recognize this standard in the future, like
all voluntary standards, it is non-binding for the purposes of
premarket review. FDA plans to work on clarified labeling
and communication of performance information so that users will
better understand how well a particular glucose meter will perform
under specified conditions.
FDA has developed a draft guidance document for coagulation
test systems
(July 14, 2003)
FDA has developed a draft guidance document to assist industry
in preparing premarket notification submissions [510(k)s] for
the instrument component of laboratory-based coagulation test
system(s). The guidance document identifies the classification
regulations and product codes for the coagulation analyzers. It
lists the risks to health identified by FDA and describes measures
that, if followed by manufacturers and combined with the general
controls, will generally address the risks associated with these
coagulation analyzers and lead to a timely 510(k) review and clearance.
This document supplements other FDA documents regarding the specific
content requirements of a 510(k) submission.
Read Document
Guidance document on quality assurance (QA) practices for
sites using the OraQuick® Rapid HIV-1 Antibody Test is now available
(July 14, 2003)
This document provides guidance on quality assurance (QA) practices
for sites using or planning to use the OraQuick® Rapid HIV-1
Antibody Test to detect antibodies to the human immunodeficiency
virus (HIV). The OraQuick Rapid HIV-1 Antibody Test is the first
rapid HIV point-of-care (i.e., testing and results are available
in one visit) test approved by the Food and Drug Administration
(FDA). It is also the first test for HIV that the FDA has waived
under the Clinical Laboratory Improvement Amendment regulations
(CLIA '88). The OraQuick test uses whole blood obtained from puncture
of a finger. Results are available within 20 to 60 minutes. Positive
results with the OraQuick rapid test are preliminary, however,
and must be followed up with an acceptable confirmatory test.
Although the OraQuick test device is simple to use and can provide
reliable results when the manufacturer’s directions are
followed, mistakes can occur at any point in the testing process.
To reduce mistakes and to ensure that the FDA restrictions for
sale of the test are followed, a site must have a QA program in
place before offering OraQuick testing. The guidelines in this
document outline the basic parts of a QA program.
Read
Document
FDA is required to post on the Internet the list of class
I and II devices we have exempted from 510(k), and to update the
Internet posting within 30 days of any revision of the list
(June 19, 2003)
Section 211 of the Medical Device User Fee and Modernization
Act (MDUFMA) amends 510(m)(1) to require FDA to post on the Internet
the list of class II devices we have exempted from 510(k), and
to update the Internet posting within 30 days of any revision
of the list. These same procedures are applied for the list of
class I devices we have exempted.
Read Document
Database for Home Use Lab Tests, also known as Over-The-Counter
(OTC) Tests is now available
(June 19, 2003)
A database of Home Use Lab Tests [Over-the-Counter tests (OTC)]
and collection kits that have been cleared or approved by the
FDA is now available for use.
Search Database
FDA releases Draft Guidance for Industry and FDA Reviewers
"Multiplex Tests for Heritable DNA Markers, Mutations and Expression
Patterns"
(May 1, 2003)
FDA released a new draft guidance for industry and CDRH reviewers
entitled “ Multiplex Tests for Heritable DNA Markers, Mutations
and Expression Patterns”. The draft guidance was published
in the Federal Register on Monday, April 21. This document, authored
by Dr. Elizabeth Mansfield in OIVD’s Division of Microbiology,
provides guidance on preparing and reviewing premarket approval
(PMA) submissions for multiplex tests, or tests that assay multiple
analytes simultaneously. This guidance primarily considers nucleic
acid based analysis such as oligonucleotide, cDNA, but many of
the principles apply to protein and tissue arrays as well. A period
of 90 days is allowed for comment on this draft guidance
Read Press Release
Roche Issues Urgent Product Correction for the Accu-Chek
Comfort Curve and Accu-Chek Advantage Glucose Test Strips
(April 3, 2003)
Roche Diagnostics Corporation has issued an urgent product correction
to all chain and independent pharmacies, diabetes health care
providers and laboratory managers in hospitals that have purchased
these Accu-Chek products. The urgent product correction alerts
them to the possibility of cracks in the bottom of Accu-Chek Comfort
Curve and Accu-Chek Advantage blood glucose test strip vials.
Roche has confirmed that this vial defect will cause erroneously
low or high blood glucose readings and that the cracks in the
vial may develop at any time, including after the vial has been
opened. The cracks in the vials appear to be due to vial manufacturing
issues.
Roche is requesting that users be advised to inspect the bottom
of every vial for cracks before each use. Users are further instructed
not to use the test strips from a cracked vial. If a crack is
not observed and blood glucose results are unusually high, low,
or inconsistent, users are instructed by Roche to repeat the test
and run a quality control check.
Roche has asked all notified pharmacist(s) and physician’s
offices to notify their patients of this urgent product correction.
This product correction refers to all lots currently available
of the Accu-Chek Comfort Curve test strips, part numbers 2030420,
2030365, 2030373, 2030381, 3000133, 3000141 and the Accu-Chek
Advantage test strips, part numbers 336, 553, 787, and 966.
FDA Draft Guidance - "Statistical Guidance on Reporting
Results from Studies Evaluating Diagnostic Tests"
(March 12, 2003)
FDA released a new draft guidance for industry and CDRH reviewers
entitled "Statistical Guidance on Reporting Results from
Studies Evaluating Diagnostic Tests.” The draft guidance
was published in the Federal Register on Wednesday, March 12.
This document, authored by Dr. Kristen Meier in OSB's Division
of Biostatistics, discusses some statistically valid approaches
for reporting results from evaluation of studies of new diagnostic
devices. It also identifies some common inappropriate practices.
Special attention is given to describing a practice called discrepant
resolution and its associated problems. A period of 90 days is
allowed for comment on this draft guidance.
Read Guidance
Roche Issues Alert About False Expiration Dates on Imported
Advantage II Glucose Test Strips.
(February 1, 2003)
Roche Diagnostics Corporation has alerted healthcare providers
that some lots of Advantage II test strips, which are intended
solely for distribution outside of the U.S., have been repackaged
and reimported into the U.S. as Accu-Chek® Comfort Curve®
test strips, in some cases with altered expiration dates. These
lots were never distributed in the U.S. and are not cleared for
sale in the U.S. by the FDA. Problems with these test strips include:
incorrect expiration dates, improper calibration for U.S. glucose
meters, and questionable product performance due to unknown storage
or handling conditions by the importer.
Read Dear Healthcare Provider
Letter
Other OIVD News
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|
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FDA
grants CLIA waiver for the use of oral fluid specimens with
the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test. |
|
FDA approved
a new test to help diagnose fungal infections |
|
NCI/FDA
Workshop: Research Srtategies, Study Designs and Statistical
Approaches to Biomarkers Validation for Cancer Diagnosis and
Detection |
|
FDA requested that manufacturers
of commercial antimicrobial susceptibility test devices take
specific actions to
minimize the risk of failing to reliably detect vancomycin resistant
S. aureus (VRSA) More
Information |
|
FDA
Approves the First Serum Antibody Test for Diagnosis of Anthrax |
|
Ortho-Clinical
Diagnostics Initiates a Voluntary Nationwide Class I Recall
of 4 lots of the VITROS Troponin Test |
|
FDA
classifies the voluntary Roche Molecular Systems COBAS TaqMan
and TaqMan 48 Analyzers recall as a Class I recall |
|
OIVD
issued Class II Special Controls Guidance Document: Immunomagnetic
Circulating Cancer Cell Selection and Enumeration System for
Industry and FDA Staff |
|
FDA issues
draft guidance for Industry titled Combination Products, Timeliness
of Premarket Reviews: Dispute Resolution Guidance |
|
Recall: Tecan
Clinical Workstation |
|
FDA Clears
the CellSearch™ Epithelial Cell Kit / CellSpotter™
Analyzr used in monitoring patients undergoing breast cancer
treatment to indicate treatment effectiveness. |
|
Recall: Meridian
ImmunoCard Stat Cryptosporidium / Giardia Rapid Assay and Becton
Dickenson (BD) ColorPac Giardia / Cryptosporidium Rapid Assay |
|
FDA
Approves First Oral Fluid Based Rapid HIV Test Kit |
|
bioMèrieux,
Inc. Recalls the VITEK GPS-107 Gram Positive Susceptibility
Card, lot M83X and FDA Classifies this Voluntary
Action as a Class I Recall |
|
FDA Recommends
that Ventana Medical Systems Inc. Submit a Premarket Approval
Application (PMA) for Their Marketed Automated INFORM® Human
Papillomavirus (HPV) In-Situ Hybridization (ISH) Diagnostic
Test System |
|
FDA Issues
Class II Special Controls Guidance Document for Factor V Leiden
DNA Mutation Detection Systems |
|
FDA
Law Allows for Electronic Labeling if Users May Still Request
Labeling in Paper Form |
|
FDA and CMS invite the CEOs of Laboratory Corp.
of America and Quest Diagnostics to discuss the nature and appropriate
regulatory status of the OvaCheck - Ovarian Cancer Screen Test
Quest Diagnostics
Letter - Lab
Corporation of American Letter |
|
FDA
Releases Version of New Database - Devices@FDA |
|
Abbott laboratories
Inc. issues a letter to customers regarding counterfeit packaging
of Precision QID Blood Glucose Test Strips |
|
FDA approves
the DakoCytomation EGFR pharmDx™ test used to identify
colorectal cancer patients eligible for treatment with the cancer
drug, ERBITUX™ (cetuximab). |
|
FDA
requests the seizure of various neonatal chemistry and isoelectric
focusing diagnostic kits at PerkinElmer Life Sciences, Inc.,
in Norton, Ohio |
|
FDA
issues letter to Abbott Laboratories regarding conformity with
the Quality System Regulation, 21 CFR Part 820. |
|
OIVD
clears the first DNA-based laboratory tests for detection of
genetic abnormalities in Factor V Leiden and Factor II (prothrombin)
genes. |
|
FDA releases
Replacement Reagent and Instrument Family Guidance document |
|
FDA
Clears the Readline Alert test to identify culture grown Bacillus
anthracis, the bacteria that causes Anthrax disease |
|
FDA
Updates and Clarifies Draft Guidance to Industry on Drug of
Abuse Screening Tests |
|
Recall:
CoaguChek PT Test Strips |
|
Recall:Laboratory
Information System Software Device, versions 5.2, 5.23, and
5.3 |
|
Recall:VIDAS
Chlamydia Assay |
|
FDA
Clears New Diabetes Device for Marketing |
|
FDA
Clears First Test for West Nile Virus |
|
Recall:
ProbeTec ™ ET Instrument |
|
FDA
cleared the Platelia Aspergillus EIA test for marketing. This
is the first rapid laboratory test for a life-threatening invasive
fungal infection, Aspergillosis |
|
FDA
Approves Expanded Use of HPV Test |
|
FDA
Clears New Lab Test to Help Rule Out Heart Attack |
|
FDA
Clears Lab Test to Diagnose Latent Tuberculosis Infections |
|
HHS
Extends Use of Rapid HIV Test to New Sites Nationwide |
|
Recall:
Roche Diagnostics Accu Chek Blood Glucose Monitoring System |
|
Recall:
CAPTIA Syphilis G Elisa Test Kit - Lot Numbers K00841, K00842,
K00838 and K00839 |
|