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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCOBAS AMPLIPREP/COBAS TAQMAN HCV TEST
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
Date Received10/27/2006
Decision Date10/30/2008
Reclassified Date 12/22/2021
Product Code MZP 
Docket Number 09M-0033
Notice Date 01/27/2009
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE COBASAMPLIPREP/COBAS TAQMAN HCV TEST. THIS DEVICE IS AN IN VITRO NUCLEIC ACID AMPLIFICATION LESTFOR THE QUANTITATION OF HEPATITIS C VIRAL (HCV) RNA IN HUMAN PLASMA OR SERUM OF HCV-INFECTEDINDIVIDUALS USING THE COBAS AMPLIPREP INSTRUMENT FOR AUTOMATED SPECIMEN PROCESSING AND THECOBAS TAQMAN ANALYZER OR THE COBAS TAQMAN 48 ANALYZER FOR AUTOMATED AMPLIFICATION ANDDETECTION. SPECIMENS CONTAINING HCV GENOTYPES 1 - 6 HAVE BEEN VALIDATED FOR QUANTITATION INTHE ASSAY. THE COBAS AMPLIPREP/COBAS TAQMAN HCV TEST IS INTENDED FOR USE AS AN AID IN THEMANAGEMENT OF HCV-INFECTED INDIVIDUALS UNDERGOING ANTI-VIRAL THERAPY. THE ASSAY MEASURESHCV RNA LEVELS AT BASELINE AND DURING TREATMENT AND CAN BE UTILIZED TO PREDICT SUSTAINED ANDNON-SUSTAINED VIROLOGICAL RESPONSE TO HCV THERAPY. THE RESULTS FROM THE COBASAMPIPREP/COBAS TAQMAN HCV TEST MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.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 SLATE OF HCV INFECTION HAS NOT BEEN ESTABLISHED."
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S012 
S014 S015 S016 S017 S018 S020 S021 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 
S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 
S075 S076 S077 S078 S079 S080 S081 S082 S083 S084 S085 S086 
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