DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
December 3, 2002
Our STN: BL 125045
Ms. Karen Long
Roche Molecular Systems, Inc.
P.O. Box 9002
4300 Hacienda Drive
Pleasanton, California 94566-0990
Dear Ms. Long:
This letter hereby issues Department of Health and Human Services U.S. License No. 1636 to Roche Molecular Systems, Inc., Pleasanton, 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 COBAS AmpliScreen HCV Test, version 2.0 (v2.0). This test is a qualitative in vitro test for the direct detection of 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 of human plasma, or pools of human plasma comprised of equal aliquots of not more than 24 individual donations. This test is intended to be used for detecting HCV RNA, in conjunction with licensed tests for detecting antibodies to HCV.
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 November 26, 2002, the following post-marketing commitments must be fulfilled:
- Roche Molecular Systems, Inc. will commence data collection immediately after licensure at Blood Establishments that add the COBAS Ampliscreen HCV Test, and report to the Center for Biologics Evaluation and Research (CBER) within 12 months the following: error rates, invalid run rates, false positives related to positional correspondence with other positive samples or controls, and variability of test performance across sites.
- Roche Molecular Systems, Inc. will modify within 12 months of licensure the AMPLILINK software to incorporate security changes and implement those changes within 18 months of licensure to ensure test results cannot be deleted by users of the system.
- Roche Molecular Systems, Inc. will submit to CBER within 3 months of licensure the remainder of the general-purpose reagents process validation package.
- Roche Molecular Systems, Inc. will send to CBER within 6 months of licensure additional test results on detectability of HCV subtypes 5a and 6a.
Roche Molecular Systems, 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 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 ---
Hira L. Nakhasi, Ph.D.
Division of Transfusion and Transmitted Diseases
Office of Blood Research and Review
Center for Biologics Evaluation and Research