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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 HCV TEST, V2.0
Generic NameAssay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Regulation Number866.3170
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
PMA NumberP060030
Supplement NumberS027
Date Received07/02/2012
Decision Date02/14/2013
Reclassified Date 12/22/2021
Product Code MZP 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DEVICE DESIGN MODIFICATIONS TO REDUCE THE SAMPLE INPUT VOLUME, IMPROVE GENOTYPE INCLUSIVITY, AND IMPROVE ASSAY SENSITIVITY TO 15 IU/ML. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS® AMPLIPREP/COBAS® TAQMAN® HCV TEST, V2.0 AND IS INDICATED FOR: THE COBAS® AMPLIPREP/COBAS® TAQMAN® HCV TEST, V2.0 IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HEPATITIS C VIRAL (HCV) RNA GENOTYPES 1 TO 6 IN HUMAN EDTA PLASMA OR SERUM OF HCV-INFECTED INDIVIDUALS USING THE COBAS® AMPLIPREP INSTRUMENT FOR AUTOMATED SPECIMEN PROCESSING AND THE COBAS® TAQMAN® ANALYZER OR THE COBAS® TAQMAN® 48 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION. THE TEST IS INTENDED FOR USE INTHE MANAGEMENT OF PATIENTS WITH CHRONIC HCV IN CONJUNCTION WITH CLINICAL AND LABORATORY MARKERS OF INFECTION. THE TEST CAN BE USED TO PREDICT THE PROBABILITY OF SUSTAINED VIROLOGIC RESPONSE (SVR) EARLY DURING A COURSE OF ANTIVIRAL THERAPY, AND TO ASSESS VIRAL RESPONSE TO ANTIVIRAL TREATMENT (RESPONSE GUIDED THERAPY) AS MEASURED BY CHANGES OF HCV RNA LEVELS IN SERUM OR EDTA PLASMA. ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH PEGINTERFERON ALFA-2A PLUS RIBAVIRIN. NO INFORMATION IS AVAILABLE ON THE ASSAY'S PREDICTIVE VALUE WHEN OTHER THERAPIES ARE USED. ASSAY PERFORMANCE FOR DETERMINING THE STATE OF HCV INFECTION HAS NOT BEEN ESTABLISHED. THE COBAS® AMPLIPREP/ COBAS® TAQMAN® HCV TEST IS NOT INTENDED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF HCV IN BLOOD OR BLOOD PRODUCTS OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HCV INFECTION.
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