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Vaccines, Blood & Biologics

February 27, 2002 Approval Letter - Procleix HIV-1/HCV Assay

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

February 27, 2002

Our STN Number: BL 103966

Mr. Glen Paul Freiberg
Gen-Probe, Inc.
10210 Genetic Center Drive
San Diego, California 92121-4362

Dear Mr. Freiberg:

This letter hereby issues Department of Health and Human Services U.S. License No. 1592 to Gen-Probe, Inc., San Diego, California, in accordance with the provisions of Section 351 (a) of the Public Health Service Act controlling the manufacture and sale of biological products. This license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards.

Under this license you are authorized to manufacture the product Procleix HIV-1/ HCV Assay. Procleix HIV-1/ HCV Assay is indicated for the qualitative detection of human immunodeficiency virus type 1 and/or hepatitis C virus RNA in human plasma from donations of whole blood and blood components for transfusion.

Under this authorization, the assay is intended for use in screening individual donor samples or pools of human plasma comprised of equal aliquots of not more than 16 individual donations. This assay is intended to be used in conjunction with licensed tests for detecting antibodies to HIV-1 and HCV. This assay may be used as an alternative to licensed HIV-1 p24 antigen tests for screening human plasma from donations of whole blood and blood components.

Changes to the product, production processes, location of production processes, equipment, facilities, or responsible personnel are required to be reported to FDA as specified in Title 21 Code of Federal Regulations (CFR) Section 601.12.

All adverse reports should be submitted according to 21 CFR Part 803 to the Center for Devices and Radiological Health, Medical Device Reporting, PO Box 3002, Rockville, Maryland 20847-3002. In addition, safety related information obtained in the course of other relevant clinical studies should be reported in accordance with 21 CFR 312.32. It is also requested that distribution reports be submitted according to 21 CFR 600.81.

As agreed upon in your Letter of Commitment dated February 22, 2002, the following post-approval commitments must be fulfilled:

  1. Gen-Probe, Inc. must adjust the purity specifications for oligonucleotides to the 5th or 10th percentile immediately below the lowest purity that has been validated (e.g., to an 85% specification if a purity of 88% has been validated). Purity specifications for the oligonucleotides must be readjusted after a minimum of ten (10) lots of each oligonucleotide have been manufactured.
  2. Immediately after licensure, Gen-Probe, Inc. must commence data collection regarding invalidation of runs due to the current "10% rule" and, within twelve (12) months of licensure, implement a software change to identify reactive results obtained in these invalid runs. The data gathered will be used to justify or, if appropriate, to modify the "10% rule."
  3. Gen-Probe, Inc. must validate the bulk formulation process for the Positive Calibrators during the manufacturing of the first three lots.
  4. Within one month of licensure, Gen-Probe, Inc. must submit a protocol for a study to identify the basis for the two (2) HCV positive specimens that were reactive at a ----- dilution but non-reactive undiluted. Gen-Probe, Inc. must complete this study within six months of licensure. In addition, Gen-Probe, Inc. must submit a protocol for a study to commence within three (3) months of licensure to evaluate the frequency of this phenomenon in seronegative specimens.

Gen-Probe, Inc. may wish to submit proposed introductory advertising and promotional campaign. If so, please submit three (3) copies of the proposed material in draft form with Part I of the FDA Form 2567/2253 to CBER, Advertising and Promotional Labeling Branch (APLB), HFM-602, 1401 Rockville Pike, Rockville, Maryland 20852-1448.

You are required to submit reports of biological product deviations in accordance with 21 CFR 600.14. All manufacturing deviations, including those associated with processing, testing, packing, labeling, storage, holding and distribution, should be promptly identified and investigated. If the deviation involves a distributed product, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, a report must be submitted on Form FDA-3486 to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Rockville, MD 20852-1448.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 2567. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels). In addition, you may wish to submit three draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2567 or Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. Final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by a FDA Form 2567 or Form 2253.

All promotional claims must be consistent with and not contrary to approved labeling. No comparative promotional claim or claim of superiority over other products should be made unless data to support such claims are submitted to and approved by the Center for Biologics Evaluation and Research.

It is recommended that a copy of this letter be available for review at the time of FDA inspections.

Sincerely yours,


--- signature ---

Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research


--- signature ---

Steven A. Masiello
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

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