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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 TAQMAN HCV TEST VERSION 2.0
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 NumberS006
Date Received12/22/2009
Decision Date09/01/2010
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 A MANUAL SPECIMEN PREPARATION OPTION TO THE CURRENTLY APPROVEDAUTOMATED SAMPLE PREPARATION METHOD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM AND IS INDICATEDFOR:THE COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM IS AN IN VITRONUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HEPATITIS C VIRUS (HCV) RNA IN HUMAN PLASMA OR SERUM OF HCV-INFECTED INDIVIDUALS USING THE HIGH PURE SYSTEM VIRAL NUCLEIC ACIDKIT FOR MANUAL SPECIMEN PREPARATION AND THE COBAS05 TAQMAN 48 ANALYZER FOR AUTOMATEDAMPLIFICATION AND DETECTION. SPECIMENS CONTAINING HCV GENOTYPES 1 THROUGH 6 HAVE BEENVALIDATED FOR QUANTITATION IN THE ASSAY.THE COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED INDIVIDUALS UNDERGOING ANTI-VIRAL THERAPY. THEASSAY MEASURES HCV RNA LEVELS AT BASELINE AND DURING TREATMENT AND CAN BE USED TO PREDICTSUSTAINED AND NON-SUSTAINED VIROLOGICAL RESPONSE TO HCV THERAPY. THE RESULTS FROM THE COBASTAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITHPEGINTERFERON 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.
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