DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health
Service Food and Drug Administration 1401 Rockville
Pike Rockville, MD 20852-1448
June 6, 2003
Ron Sanyal bioMerieux, Inc. 100 Rodolphe
Street Durham, NC 27712
Re: BP020066/0 Product: Vironostika HIV-1 Plus O
Microelisa System Device Code: MZF
Date Received: 10-DEC-02
Dear Mr. Sanyal:
The Center for Biologics Evaluation and Research (CBER) of
the Food and Drug Administration (FDA) has completed its
review of your premarket approval application (PMA) for the
Vironostika HIV-1 Plus O Microelisa System. This device is
indicated for the qualitative detection of antibodies to Human
Immunodeficiency Virus Type 1 (HIV-1), including Group O, in
human specimens collected as serum, plasma, or dried blood
spots. We are pleased to inform you that the PMA is approved.
You may begin commercial distribution of the device in
accordance with the conditions described below and in the
"Conditions of Approval" (enclosed).
We remind you that the sale, distribution, and use must not
violate sections 502(q) and (r) of the Act. Further, no
advertisement or other descriptive printed material issued by
the applicant or private label distributor with respect to
this device shall recommend or imply that the device may be
used for any use that is not included in the FDA-approved
labeling for the device.
Expiration dating for this device has been established and
approved at 15 months at 2oC to 8oC.
CBER does not evaluate information related to contract
liability warranties, however you should be aware that any
such warranty statements must be truthful, accurate, and not
misleading, and must be consistent with applicable Federal and
State laws.
CBER will notify the public of its decision to approve your
PMA by making available a summary of the safety and
effectiveness data upon which the approval is based. The
information can be found on the FDA CBER Internet website
located at http://www.fda.gov/cber/products/testkits.htm.
Written requests for this information can also be made to the
Dockets Management Branch, (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. The written request should include the PMA number or
docket number. Within 30 days from the date that this
information is placed on the Internet, any interested person
may seek review of this decision by requesting an opportunity
for administrative review, either through a hearing or review
by an independent advisory committee, under section 515(g) of
the Act.
Failure to comply with the conditions of approval
invalidates this approval order. Commercial distribution of a
device that is not in compliance with these conditions is a
violation of the Act.
If you have any questions concerning this approval order,
please contact Hilary Cooper at (301) 827-5307
Sincerely yours,
--- signature ---
Hira L. Nakhasi, Ph.D. Director Division of Emerging
and Transfusion Transmitted
Diseases Office of Blood Research and Review Center for
Biologics Evaluation and Research
CONDITIONS OF APPROVAL
APPROVED LABELING. As soon as possible,
and before commercial distribution of your device, submit
three copies of an amendment to this PMA submission with
copies of all approved labeling in final printed form to
Document Control Center (HFM-99), Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, Rockville, Maryland 20852-1448
ADVERTISEMENT. No advertisement or other
descriptive printed material issued by the applicant or
private label distributor with respect to this device shall
recommend or imply that the device may be used for any use
that is not included in the FDA approved labeling for the
device. If the FDA approval order has restricted the sale,
distribution and use of the device to prescription use in
accordance with 21 CFR 801.109 and specified that this
restriction is being imposed in accordance with the provisions
of section 520(e) of the Act under the authority of section
515(d)(1)(B)(ii) of the Act, all advertisements and other
descriptive printed material issued by the applicant or
distributor with respect to the device shall include a brief
statement of the intended uses of the device and relevant
warnings, precautions, side effects and contraindications.
PREMARKET APPROVAL APPLICATION (PMA)
SUPPLEMENT. Before making any change affecting the
safety or effectiveness of the device, submit a PMA supplement
for review and approval by FDA unless the change is of a type
for which a "Special PMA Supplement-Changes Being Effected" is
permitted under 21 CFR 814.39(d) or an alternate submission is
permitted in accordance with 21 CFR 814.39(e). A PMA
supplement or alternate submission shall comply with
applicable requirements under 21 CFR 814.39 of the final rule
for Premarket Approval of Medical Devices.
All situations which require a PMA supplement cannot be
briefly summarized, please consult the PMA regulation for
further guidance. The guidance provided below is only for
several key instances.
A PMA supplement must be submitted when unanticipated
adverse effects, increases in the incidence of anticipated
adverse effects, or device failures necessitate a labeling,
manufacturing, or device modification.
A PMA supplement must be submitted if the device is to be
modified and the modified device should be subjected to animal
or laboratory or clinical testing designed to determine if the
modified device remains safe and effective.
A "Special PMA Supplement - Changes being
Effected" is limited to the labeling, quality control
and manufacturing process changes specified under 21 CFR
814.39(d)(2). It allows for the addition of, but not the
replacement of previously approved, quality control
specifications and test methods. These changes may be
implemented before FDA approval upon acknowledgment by FDA
that the submission is being processed as a "Special PMA
Supplement - Changes Being Effected.” This procedure is not
applicable to changes in device design, composition,
specifications, circuitry, software or energy source.
Alternate submissions permitted under 21
CFR 814.39(e) apply to changes that otherwise require approval
of a PMA supplement before implementation of the change and
include the use of a 30-day PMA supplement or
annual post-approval report. FDA must have
previously indicated in an advisory opinion to the affected
industry or in correspondence with the applicant that the
alternate submission is permitted for the changes. Before such
can occur, FDA and the PMA applicant(s) involved must agree
upon any needed testing protocol, test results, reporting
format, information to be reported, and the alternate
submission to be used.
POST-APPROVAL REPORTS. Continued approval
of this PMA is contingent upon the submission of post-approval
reports required under 21 CFR 814.84 at intervals of 1 year
from the date of approval of the original PMA. Post-approval
reports for supplements approved under the original PMA, if
applicable, are to be included in the next and subsequent
annual reports for the original PMA unless specified otherwise
in the approval order for the PMA supplement. Two
copies identified as "Annual Report"
and bearing the applicable PMA reference number are to be
submitted to the Document Control Center (HFM-99), Center for
Biologics Evaluation and Research, Food and Drug
Administration, 1401 Rockville Pike, Rockville, Maryland
20852-1448. The post-approval report shall indicate the
beginning and ending date of the period covered by the report
and shall include the following information required by 21 CFR
814.84:
- Identification of changes described in 21 CFR 814.39(a)
and changes required to be reported to FDA under 21 CFR
814.39(b).
- Bibliography and summary of the following information
not previously submitted as part of the PMA and that is
known to or reasonably should be known to the applicant:
- Unpublished reports of data from any clinical
investigations or nonclinical laboratory studies involving
the device or related devices ("related" devices include
devices which are the same or substantially similar to the
applicant's device); and
- Reports in the scientific literature concerning the
device.
If, after reviewing the bibliography and summary, FDA
concludes that agency review of one or more of the above
reports is required, the applicant shall submit two copies of
each identified report when so notified by FDA.
ADVERSE REACTION AND DEVICE DEFECT
REPORTING. As provided by 21 CFR 814.82(a)(9), FDA
has determined that in order to provide continued reasonable
assurance of the safety and effectiveness of the device, the
applicant shall submit 3 copies of a written
report identified, as applicable, as an "Adverse
Reaction Report" or "Device Defect
Report" to MedWatch (HF-2), Food and Drug
Administration, 5600 Fishers Lane, Rockville, Maryland
20852-9787 within 10 days after the applicant
receives or has knowledge of information concerning:
- A mixup of the device or its labeling with another
article.
- Any adverse reaction, side effect, injury, toxicity, or
sensitivity reaction that is attributable to the device and
- Has not been addressed by the device's labeling or
- Has been addressed by the device's labeling, but is
occurring with unexpected severity or frequency.
- Any significant chemical, physical or other change or
deterioration in the device or any failure of the device to
meet the specifications established in the approved PMA that
could not cause or contribute to death or
serious injury but are not correctable by
adjustments or other maintenance procedures described in the
approved labeling. The report shall include a discussion of
the applicant's assessment of the change, deterioration or
failure and any proposed or implemented corrective action by
the applicant. When such events are correctable by
adjustments or other maintenance procedures described in the
approved labeling, all such events known to the applicant
shall be included in the Annual Report described under
"Post-approval Reports" above unless specified otherwise in
the conditions of approval to this PMA. This post-approval
report shall appropriately categorize these events and
include the number of reported and otherwise known instances
of each category during the reporting period. Additional
information regarding the events discussed above shall be
submitted by the applicant when determined by FDA to be
necessary to provide continued reasonable assurance of the
safety and effectiveness of the device for its intended use.
REPORTING UNDER THE MEDICAL DEVICE REPORTING (MDR)
REGULATION. The Medical Device Reporting (MDR)
Regulation became effective on December 13, 1984. This
regulation was replaced by the reporting requirements of the
Safe Medical Devices Act of 1990, which became effective on
July 31, 1996, and requires that all manufacturers and
importers of medical devices, including in vitro diagnostic
devices, report to the FDA whenever they receive or otherwise
become aware of information, from any source, that reasonably
suggests that a device marketed by the manufacturer or
importer:
- May have caused or contributed to a death or serious
injury; or
- Has malfunctioned and such device or similar device
marketed by the manufacturer or importer would be likely to
cause or contribute to a death or serious injury if the
malfunction were to recur.
The same events subject to reporting under the MDR
Regulation may also be subject to the above "Adverse Reaction
and Device Defect Reporting" requirements in the "Conditions
of Approval" for this PMA. FDA has determined that such
duplicative reporting is unnecessary. Whenever an event
involving a device is subject to reporting under both the MDR
Regulation and the "Conditions of Approval" for a PMA, the
manufacturer shall submit the appropriate reports
required by the MDR Regulation within the time frames
as identified in 21 CFR 803.10 (c) using FDA Form 3500A, i.e.,
30 days after becoming aware of a reportable death, serious
injury, or malfunction as described in 21 CFR 803.50 and 21
CFR 803.52 and 5 days after becoming aware that a reportable
MDR event requires remedial action to prevent an unreasonable
risk of substantial harm to the public health. The
manufacturer is responsible for submitting a baseline report
on FDA Form 3417 for a device when the device model is first
reported under 21 CFR 803.50. This baseline report is to
include the PMA reference number. Any written report and its
envelope is to be specifically identified, e.g., "Manufacturer
Report," "5-Day Report," "Baseline Report," etc.
Any written report is to be submitted to:
Food and Drug Administration Center for Devices and
Radiological Health Medical Device Reporting P. O. Box
3002 Rockville, MD 20847-3002
Copies of the MDR Regulation (FOD # 336 & 1336) and FDA
publications entitled "An Overview of the Medical Device
Reporting Regulation" (FOD #509) and "Medical Device Reporting
for Manufacturers" (FOD #987) are available on the CDRH WWW
Home Page. They are also available through CDRH's
Fact-On-Demand (F-O-D) at 800-899-0381. Written requests for
information can be made by sending a facsimile to CDRH's
Division of Small Manufacturers Assistance (DSMA) at
301-443-8818.
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