DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
June 23, 2004
Mr. Hermes Chan
155 Chain Lake Drive, Bayers Lake
Halifax, Nova Scotia B3S 1B3
Product: MedMira Reveal G2 Rapid HIV-1 Antibody Test
Device Code: MZF
Date Received: 29-DEC-03
Dear Mr. Chan:
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 Reveal TM G2 Rapid HIV-1 Antibody Test. This supplement is to allow for the addition of a procedural and reagent control line, a change in the packaging of the Colorimetric Detection Agent, and a change in the name of the device to Reveal TM G2 Rapid HIV-1 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 14, 2004:
MedMira will submit to FDA within 6 months following the approval of this PMA supplement the results of a study comparing -------- determinations using ------------------------------------- for the testing process. This study will be done using 3 lots of conjugate.
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