August 16, 2007 Approval Letter - COBAS AmpliScreen HBV
Our STN: BL 125090/21
Roche Molecular Systems, Inc.
Attn: Mr. Larry Pietrelli
4300 Hacienda Drive
P.O. Box 9002 Pleasanton, CA 94566-0990
Dear Mr. Pietrelli:
We have approved your request to supplement your biologics license application for Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived) for its use in the COBAS AmpliScreen HBV Test for changes in the labeling, testing requirement, and an increase in reagent refrigerator cycles.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format and Word-format electronic copy as well as original paper copies (five for circulars and five for other labels).
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.
We will include information contained in the above-referenced supplement in your biologics license application file.
--- signature ---
H ira L. Nakhasi, Ph.D.
Division of Emerging and Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics Evaluation and Research