DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
June 22, 2004
Ms. Eve Damiano
220 East First Street
Bethlehem, PA 18015-1360
Re: BP010047 / 16
Product: OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
Device Code: MTL
Date Received: 10-JUN-04
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 ADVANCE Rapid HIV-1/2 Antibody Test. This supplement is to allow for an added labeling claim for the detection of HIV-2 antibodies in oral fluid and to allow for a change in the name of the device to OraQuick ADVANCE Rapid HIV-1/2 Antibody Test. We are pleased to inform you that the PMA supplement is approved subject to the conditions described below, as agreed upon in your letter dated June 17, 2004:
- OraSure Technologies will use best efforts to identify and test paired oral fluid and whole blood specimens for seven (7) additional HIV-2 (only) positive individuals within twelve (12) months of approval.
- OraSure Technologies will provide the FDA/CBER with Western Blot results for the oral fluid specimens tested in support of the HIV-2 oral fluid claim within twelve (12) months of approval.
If you have any questions concerning this approval order, please contact Hilary Cooper at (301) 827-5307.
--- 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