DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
April 21, 2005
Our STN: BL 125090
Roche Molecular Systems, Inc.
Attention: Karen Long
P.O. Box 9002
4300 Hacienda Drive
Pleasanton, California 94566-0990
Dear Ms. Long:
Your Biologics License Application for COBAS AmpliScreen HBV Test to include a qualitative in vitro test for the direct detection of Hepatitis B Virus (HBV) DNA in human plasma from donations of Whole Blood and blood components for transfusion, and Source Plasma, has been approved effective today. Roche Molecular Systems is hereby authorized to introduce or deliver COBAS AmpliScreen HBV Test for introduction into interstate commerce, manufactured at Roche Molecular Systems under U.S. License No. 1636.
Under this license you are authorized to manufacture the product COBAS AmpliScreen HBV Test. This test is a qualitative in vitro test for the direct detection of Hepatitis B Virus (HBV) DNA in human plasma. This product is intended for use as a donor-screening test to detect HBV DNA in plasma samples from individual human donors, including donors of Whole Blood and blood components, and Source Plasma. Your request for additional indications for testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating) for HBV DNA has also been approved.
Under this authorization, for donations of Whole Blood and blood components, this assay is intended for use in screening individual donor samples of human plasma, or pools of human plasma comprised of equal aliquots of not more than 24 individual donations in conjunction with licensed tests for detecting hepatitis B surface antigen (HBsAg) and antibody to hepatitis B core antigen (anti-HBc). For donations of Source Plasma, this assay is intended for use in screening individual donor plasma samples or pools of plasma samples comprised of equal aliquots of not more than 96 individual samples in conjunction with licensed tests for detecting HBsAg. For other donations from individual living donors, including heart-beating organ donors, this assay is intended for use in screening individual donor samples of human plasma in conjunction with licensed tests for detecting hepatitis B surface antigen (HBsAg) and antibody to hepatitis B core antigen (anti-HBc).
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.
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 an 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.
--- signature ---
Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research