DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
November 7, 2002
Dr. R. Sam Niedbala
OraSure Technologies, Inc.
150 Webster Street
Bethlehem, Pennsylvania 18015-1389
Product: OraQuick Rapid HIV-1 Antibody Test
Device Code: MTL
Date Received: 13-NOV-01
Dear Dr. Niedbala:
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 OraQuick Rapid HIV-1 Antibody Test. This device is indicated for the detection of HIV-1 antibodies in fingerstick whole blood specimens. 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).
In order to ensure the safe and effective use of this device, the sale, distribution, and use of this device are restricted within the meaning of section 520(e) of the Federal Food, Drug, and Cosmetic Act (the Act) under the authority of section 515(d)(1)(B)(ii) of the Act, as follows:
The labeling must specify that
sale of the OraQuick Rapid HIV-1 Antibody Test is restricted to clinical laboratories that have an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met; and where there is assurance that operators will receive and use the instructional materials;
the OraQuick Rapid HIV-1 Antibody Test is approved for use only by an agent of a clinical laboratory;
test subjects must receive the "Subject Information" pamphlet prior to specimen collection and appropriate information when test results are provided;
- the OraQuick Rapid HIV-1 Antibody Test is not approved for use to screen blood or tissue donors.
- You must provide a letter to all purchasers advising them of these restrictions.
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.
As a condition to approval of the device, you have agreed to provide three copies of the following data, referencing this PMA control number, to the Document Control Center (HFM-99), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, Maryland 20852-1448:
(Item ---------) and blocker pad (Item ---------).
Expiration dating for this device has been established and approved at 5 months at 2°C to 27°C. This is to advise you that the protocol you used to establish this expiration dating is considered an approved protocol for the purpose of extending the expiration dating as provided by 21 CFR 814.39(a)(7).
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 Sayah Nedjar, Ph.D., at (301) 827-5307.
--- signature ---
Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research