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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOBAS AMPLIPREP/COBAS TAQMAN HBV TEST
Generic NameHepatitis Viral B DNA Detection
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
PMA NumberP050028
Supplement NumberS004
Date Received07/01/2009
Decision Date09/09/2010
Product Code MKT 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A DEVICE DESIGN MODIFICATION THAT INCLUDES REAGENTS, DISPOSABLES,AND INSTRUMENTATION, TO AUTOMATE THE MANUAL SAMPLE PREPARATION PROCESS CURRENTLY USED BY THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM. THE DEVICE, AS MODIFIED,WILL BE MARKETED UNDER THE TRADE NAME COBAS AMPLIPREP/ COBAS TAQMAN HBV TEST, V2.0AND IS INDICATED FOR:THE COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 IS AN IN VITRO NUCLEIC ACIDAMPLIFICATION LEST FOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN SERUM ORPLASMA (EDTA), USING THE COBAS AMPLIPREP INSTRUMENT FOR AUTOMATED SPECIMEN PROCESSINGAND THE COBAS TAQMAN ANALYZER OR COBAS TAQMAN 48 ANALYZER FOR AUTOMATEDAMPLIFICATION AND DETECTION.THIS TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF PATIENTS WITH CHRONIC HBV INFECTIONUNDERGOING ANTIVIRAL THERAPY. THE TEST CAN BE USED TO MEASURE HBV DNA LEVELS AT BASELINE AND DURING TREATMENT TO AID IN ASSESSING RESPONSE TO TREATMENT. THE RESULTS FROM THE COBASAMPLIPREP/ COBAS TAQMAN1 HBV TEST, V2.0 MUST BE INTERPRETED WITHIN THE CONTEXT OF ALLRELEVANT CLINICAL AND LABORATORY FINDINGS.ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH ADEFOVIRDIPIVOXIL. ASSAY PERFORMANCE FOR DETERMINING THE SLATE OF HBV INFECTION HAS NOT BEEN ESTABLISHED.THE COBAS AMPLIPREP/ COBAS TAQMAN HBV TEST, V2.0 IS NOT INTENDED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF HBV IN BLOOD OR BLOOD PRODUCTS OR AS A DIAGNOSTIC TEST TOCONFIRM THE PRESENCE OF HBV INFECTION.
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