February 26, 2009
Our STN: BL 125255/0
Roche Molecular Systems, Inc.
Attention: Carol Pachl, Ph.D.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
Dear Dr. Pachl:
This letter corrects our approval letter dated December 30, 2008. This letter has been corrected to clarify the indications for use.
We have approved your biologics license application for the cobas TaqScreen MPX Test, for use on the cobas s 201 system, effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, the cobas TaqScreen MPX Test under your existing Department of Health and Human Services U.S. License No. 1636. The cobas TaqScreen MPX Test is an in vitro test indicated for the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA in human plasma. The cobas TaqScreen MPX Test is intended to be used as a screening test for individual human donors, including donors of Whole Blood and blood components, and other living donors, for the presence of HIV-1 Group M RNA, HCV RNA and HBV DNA. It is also intended for use in testing plasma specimens to screen individual organ donors when specimens are obtained while the donor's heart is still beating.
Plasma from all donors may be screened as individual specimens. For donations of Whole Blood and blood components, plasma specimens may be tested individually or in pools comprised of not more than six equal aliquots of individual specimens in conjunction with serology tests for HIV, HCV or HBV. For donors of hematopoietic stem/progenitor cells (HPCs) sourced from bone marrow, peripheral blood or cord blood, and for donors of donor lymphocytes for infusion (DLI), plasma may be tested in pools comprised of equal aliquots of not more than six individual donor specimens. Whereas this test can detect HIV-1 Group O RNA and HIV-2 RNA, detection of HIV-1 Group O RNA or HIV-2 RNA in donor specimens negative for anti-HIV-1 Group O antibodies or anti-HIV-2 antibodies, respectively, has not been demonstrated in clinical studies. This test is not intended for use as an aid in diagnosis of infection with HIV, HCV or HBV. It is not intended for use on cord blood specimens. This test is not intended for use to screen donations of Source Plasma, except for collections from donors who concurrently meet Whole Blood donor standards.
Under this license, you are approved to manufacture the cobas TaqScreen MPX Test at your facility located at 1080 US Highway 202, Branchburg Township, Somerville, NJ 08876-3771. You must label your product with the proprietary name of cobas TaqScreen MPX Test, and market it as approved in your license application.
The expiration date for the packaged product, cobas TaqScreen MPX Test, shall be dependent on the shortest expiration date of any kit component when stored at the required temperature for that kit component.
Please submit final container samples of the product and each kit component in final containers together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologics Evaluation and Research (CBER).
You must submit information to your biologics license application for our review and written approval under 21 CFR 601.12 for any changes in the manufacturing, testing, packaging or labeling of cobas TaqScreen MPX Test, or in the manufacturing facilities.
Submit adverse experience reports in accordance with the Medical Device Reporting requirements for medical devices (21 CFR 803) as required by (21 CFR 600.81(k)(2)). Since your product is characterized as a device as well as a biologic, submit these reports to the MedWatch System using MedWatch Reporting Form 3500A. Required reports should be submitted to the Food and Drug Administration, Center for Devices and Radiological Health, Medical Device Reporting, PO Box 3002, Rockville, Maryland 20847-3002.
You must submit reports of biological product deviations under 21 CFR 600.14. You promptly should identify and investigate all manufacturing deviations, including those associated with processing, testing, packing, labeling, storage, holding and distribution. 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, you must submit a report 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 356h and FDA Form 2567 as appropriate. 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 two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. Two copies of final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by a FDA Form 2253.
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 submitted data to support such claims to us and had them approved.
Jay S. Epstein, M.D.
Office of Blood
Research and Review
Center for Biologics Evaluation and Research