OIVD News Archive

FDA Publishes a New Guidance Document on Assay Migration Studies for IVDs
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, January 5, 2009

This draft guidance presents a regulatory approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously approved or licensed assay is migrating (i.e., transitioning) to another system for which the assay has not been previously approved or licensed. The focus of this guidance is on the study designs and performance criteria that should be fulfilled in order for a sponsor to utilize the migration study approach in support of the change. The guidance document describes information that FDA recommends sponsors include in a PMA (premarket approval application) supplement or a BLA (Biologics License Application). This guidance does not apply to immunohematology tests licensed by the Center for Biologics Evaluation and Research (CBER). This guidance can be used for 510(k) devices where the Replacement Reagent and Instrument Family Policy does not apply (e.g., nucleic acid amplification tests) and devices for which transition to a New System presents specific concerns, either because of the nature of the analyte and indications, or because of the specific technology used.

For more information see the Guidance Document.

FDA Issued a Warning Letter to the CEO of LabCorp Regarding The Illegal Marketing of The OvaSure™ Test
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration. September 29, 2008

Following the review of information obtained from Laboratory Corporation of America (LabCorp) website including a press release and a technical bulletin as well as information provided by LabCorp in a face to face meeting with the Food and Drug Administration (FDA) on September 5, 2008, FDA issued a Warning Letter to LabCorp.

In this Warning Letter the FDA informed David P. King, President and Chief Executive Officer of LabCorp that his firm was in serious violation of the Food, Drug, and Cosmetic Act involving the illegal marketing of the OvaSure™ test and asked that the violations be promptly corrected to avoid initiation of regulatory action by the FDA.

FDA Clears New CDC Test to Detect Human Influenza
Source: Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Food and Drug Administration (FDA), September 30, 2008

The FDA cleared for marketing the new test developed by the U.S. Centers for Disease Control and Prevention (CDC) to diagnose human influenza infections and the highly pathogenic influenza A (H5N1) viruses.

The test, called the Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel), uses a molecular biology technique to detect flu virus and differentiate between seasonal and novel influenza.

For more information on rRT-PCR Flu Panel test, and statements made by HHS Secretary Mike Leavitt, and CDC Director Julie Gerberding read the FDA’s Press Release.

For more information on flu go to www.pandemicflu.gov, and www.cdc.gov

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:

• Rapid Lead Screening Test - Questions and Answers

For more information on lead, visit:

• www.cdc.gov/nceh/lead/
• www.hud.gov/offices/lead/
• www.epa.gov/lead/

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)

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.

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

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