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June 29, 1998 Approval Letter
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
June 29, 1998
Our Reference Number: 96-0959
Mr. Reed W. Simmons
Genetic Systems Corporation
6565 185th Avenue NE
Redmond, WA 98052-5039
Dear Mr. Simmons:
The Center for Biologics Evaluation and Research (CBER) has completed its review of your request to supplement your product license application for Human Immunodeficiency Virus Type 1, to include the manufacture and sale in interstate and foreign commerce a new HIV-1 enzyme immunoassay (EIA) which contains a combination of HIV-1 viral lysate and HIV-Z recombinant antigen, i.e., the Genetic Systems rLAV EIA. This in vitro qualitative enzyme immunoassay is to be used for the detection of antibodies to Human Immunodeficiency Virus type 1 in human serum, plasma, and dried blood spots.
Based upon the review of information provided in support of your request, the supplement has been found acceptable.
You are requested to submit samples of each future master lot of the product test kit together with protocols consisting of a summary of essential manufacturing data inclusive of all applicable test results. No master lots of the product test kit shall be distributed until notification of release is received from the Director of CBER.
The expiration dating for the Genetic Systems rLAV EIA is 12 months when stored at 2-8° C. Any request to extend this dating period must be accompanied by the results of ongoing stability studies.
Any lot of Genetic Systems rLAV EIA found to fall outside of the approved specifications, including expiration dating periods, should be withdrawn from the market. In addition, any reports of significant product defects or product complaints concerning the use of the Genetic Systems rLAV EIA should be submitted to the Office of Compliance, CBER, HEM-650.
A copy of your labeling submission for the Genetic Systems rLAV EIA is enclosed. Please submit three copies of final printed labeling at the time of use and include part II of the label transmittal form (Form FDA 2567) with completed implementation information.
In addition, please submit three copies of the proposed introductory advertising and promotional labeling. You may wish to submit the proposed materials in draft form with an FDA form 2567 to CBER, Advertising and Promotional Labeling Staff, HFM-202. Promotional claims should be consistent with and not contrary to approved labeling. No comparative claims or claim of superiority over other similar products should be made unless data to support such claims are submitted to and approved by CBER.
This information will be placed on file with your product license application for Human Immunodeficiency Virus Type 1.
--- signature ---
Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research