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December 19, 2014 Approval Letter - cobas TaqScreen MPX Test, version 2.0 for use with the cobas s 201 system

December 19, 2014 Approval Letter - cobas TaqScreen MPX Test, version 2.0 for use with the cobas s 201 system

Our STN: BL125459/0                                                                                      

Roche Molecular Systems, Inc.
Attention: Ms. Angela Tucker
4300 Hacienda Drive
Pleasanton, CA  94588

Dear Ms. Tucker:

We have approved your biologics license application for HIV-1 Group O and M, HIV-2, HCV and/or HBV (HIV-1/HIV-2/HCV/HBV/Multiplex Discriminatory NAT) effective this date.   You are hereby authorized to introduce or deliver for introduction into interstate commerce, HIV-1 Group O and M, HIV-2, HCV and/or HBV (HIV-1/HIV-2/HCV/HBV/Multiplex Discriminatory NAT) under your existing Department of Health and Human Services U.S. License No. 1636.  HIV-1 Group O and M, HIV-2, HCV and/or HBV (HIV-1/HIV-2/HCV/HBV/Multiplex Discriminatory NAT) is indicated for use with the cobas s 201 system, is a qualitative in vitro test for the direct 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. 

This test is intended for use to screen for HIV RNA, HCV RNA, and HBV DNA in plasma specimens from human donors, including donors of Whole Blood, blood components, Source Plasma, and other living donors.  This test is also intended for use in testing plasma to screen organ and tissue donors when specimens are obtained while the donor’s heart is still beating.  For donations of Whole Blood and blood components, plasma specimens may be tested individually or in pools comprised of equal aliquots of not more than 6 individual specimens.  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 not more than 6 individual specimens.  For donations of Source Plasma, the sample may be tested in pools comprised of equal aliquots of not more than 96 individual 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 intended to be used in conjunction with licensed serology tests for HIV, HCV, and HBV.  For an individual specimen, results are simultaneously detected and discriminated for HIV, HCV, and HBV.  This test is not intended for use as an aid in diagnosis of infection with HIV, HCV, or HBV.

Under this authorization, you are approved to manufacture HIV-1 Group O and M, HIV-2, HCV and/or HBV (HIV-1/HIV-2/HCV/HBV/Multiplex Discriminatory NAT) at your facility in Branchburg Township, Somerville, New Jersey.  You may label your product with the proprietary name cobas® TaqScreen MPX Test, version 2.0, and you may market it in the U.S.
We did not refer your application to the Blood Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.

The dating period for HIV-1 Group O and M, HIV-2, HCV and/or HBV (HIV-1/HIV-2/HCV/HBV/Multiplex Discriminatory NAT) shall be 12 months when stored at the required temperature of the kit components.  We have approved the stability protocol in your license application for the purpose of extending the expiration dating of your kit under 21 CFR 610.12. 

Please submit final container samples of the product and each kit component 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, including but not limited to, the manufacturing, testing, packaging, or labeling of HIV-1 Group O and M, HIV-2, HCV and/or HBV (HIV-1/HIV-2/HCV/HBV/Multiplex Discriminatory NAT), or in the manufacturing facilities.

You must submit reports of biological product deviations under 21 CFR 600.14.  You should identify and investigate all manufacturing deviations promptly, 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, at the following address:

Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Ave.
WO71-G112
Silver Spring, MD  20993-0002

Please submit all final printed labeling at the time of use and include implementation information on Form FDA 356h and Form FDA 2567 as appropriate.  Please provide a PDF electronic copy as well as three original paper copies for circulars and other labels.

Two draft copies of the proposed introductory promotional labeling may be voluntarily submitted for advisory comment with a Form FDA 2253 to the Advertising and Promotional Labeling Branch, at the following address:

Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Ave.
WO71-G112
Silver Spring, MD  20993-0002

You must submit adverse experience reports in accordance with the Medical Device Reporting requirements for medical devices (21 CFR 803) as required by (21 CFR 600.80(k)(2)).  Since your product is characterized as a device as well as a biological, 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, P.O. Box 3002, Rockville, Maryland 20847-3002.

Statement on Pediatric Postmarket Surveillance of Devices

Pediatric postmarket surveillance of devices ordered under section 522 of the Federal Food, Drug and Cosmetic Act must be registered at ClinicalTrials.gov in accordance with the provisions of Section 801 of FDAAA.

Please contact register@clinicaltrials.gov to determine the best mechanism for using ClinicalTrials.gov to address this provision.

AGREED UPON POSTMARKETING COMMITMENTS

We acknowledge your written commitments as described in your letter of October 6, 2014 as outlined below:

Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70.  

1. RMS commits to monitor for instances of HCV true positive samples that are reported as invalid due to the presence of signal spiking effects in the MPX v2.0 through RMS' Complaint Handling Program.  The unnormalized raw data associated with complaints of this nature will be analyzed to verify the presence of signal spiking effects and samples will be requested for retesting.  The complaint investigations will be stored in the RMS case handling system, will be periodically reported to FDA as a PMC Submission-Status Update, and will be included in the Annual Reports to FDA through the life cycle of the product.

2. RMS commits to monitor for the occurrence of mutations that could result in failure to detect some HIV -1 positive specimens through its Complaint Handling Program.  Customer complaints that meet the criteria for a potentially critical complaint, (e.g., failure to detect HIV-1 mutations) are escalated for handling and investigation to the Complaint Investigation Resolution (CIR) group.

Requests for samples that result in a failure to detect HIV -1 positive specimens are made for additional investigation activities, which may include sequence analysis or testing with an alternative platform that detects the LTR region of the HIV-1 genome.

Specific information pertaining to HIV -1 mutations complaint investigations will be stored in the RMS case-handling system, will be periodically reported to FDA as a PMC Submission-Status Update, and will be included in the Annual Reports to FDA through the life cycle of the product.

We request that you submit information concerning nonclinical and chemistry, manufacturing, and control postmarketing commitments and final reports to your BLA, STN BL 125459.

Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments as appropriate:

  • Postmarketing Study Correspondence
  • Postmarketing Study Commitment – Final Study Report
  • Supplement Contains Postmarketing Study Commitment – Final Study Report

For each postmarketing commitment not subject to the reporting requirements of 21 CFR 601.70, you may report the status to FDA as a “PMC Submission – Status Update.”  The status report for each commitment should include:

  • The original schedule for the commitment, and
  • The status of the commitment (i.e., pending, ongoing, delayed, terminated, or submitted).

When you have fulfilled your commitment, submit your final report as PMC Submission – Final Study Report or Supplement Contains Postmarketing Study Commitment – Final Study Report.

Sincerely yours,

Ginette Michaud, MD for
Jay S. Epstein, MD
Director
Office of Blood Research and Review
Center for Biologics
Evaluation and Research

Enclosure


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