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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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September 5, 2003 Approval Letter - OraQuick Rapid HIV-1 Antibody Test





Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

September 5, 2003

Ms. Eve Damiano
OraSure Technologies
150 Webster Street
Bethlehem, Pennsylvania 18015-1389

Re: BP010047/7
Product: OraQuick Rapid HIV-1 Antibody Test
Device Code: MTL

Date Received: 08-MAY-03

Dear Ms. Damiano:

The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) has completed its review of your premarket approval supplement (PMA Supplement) for the OraQuick Rapid HIV-1 Antibody Test. This supplement is to allow for a labeling claim for the detection of antibodies to HIV-1 in venipuncture whole blood specimens and to reduce the maximum read time from 60 minutes to 40 minutes. We are pleased to inform you that the PMA Supplement is approved. You may continue commercial distribution of the device upon receipt of this letter.

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.
Division of Emerging and Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics Evaluation and Research