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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 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 NumberP150015
Date Received04/27/2015
Decision Date10/14/2015
Reclassified Date 12/22/2021
Product Code MZP 
Docket Number 15M-4018
Notice Date 11/03/2015
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE COBAS HCV. THIS DEVICE IS INDICATED FOR: COBAS HCV IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR BOTH THE DETECTION AND QUANTITATION OF HEPATITIS C VIRUS (HCV) RNA, IN HUMAN EDTA PLASMA OR SERUM, OF HCV ANTIBODY POSITIVE OR HCV-INFECTED INDIVIDUALS. SPECIMENS CONTAINING HCV GENOTYPES 1 TO 6 ARE VALIDATED FOR DETECTION AND QUANTITATION IN THE ASSAY. COBAS HCV IS INTENDED FOR USE AS AN AID IN THE DIAGNOSIS OF HCV INFECTION IN THE FOLLOWING POPULATIONS: INDIVIDUALS WITH ANTIBODY EVIDENCE OF HCV WITH EVIDENCE OF LIVER DISEASE, INDIVIDUALS SUSPECTED TO BE ACTIVELY INFECTED WITH HCV ANTIBODY EVIDENCE, AND INDIVIDUALS AT RISK FOR HCV INFECTION WITH ANTIBODIES TO HCV. DETECTION OF HCV RNA INDICATES THAT THE VIRUS IS REPLICATING AND THEREFORE IS EVIDENCE OF ACTIVE INFECTION.COBAS HCV IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED PATIENTS UNDERGOING ANTI-VIRAL THERAPY. THE ASSAY CAN BE USED TO MEASURE HCV RNA LEVELS AT BASELINE, DURING TREATMENT, AT THE END OF TREATMENT, AND AT THE END OF FOLLOW UP OF TREATMENT TO DETERMINE SUSTAINED OR NON-SUSTAINED VIRAL RESPONSE. THE RESULTS MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.COBAS HCV HAS NOT BEEN APPROVED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF HCV IN BLOOD OR BLOOD PRODUCTS. ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH CERTAIN DIRECT-ACTING ANTIVIRAL AGENTS (DAA) REGIMENS. NO INFORMATION IS AVAILABLE ON THE ASSAYS PREDICTIVE VALUE WHEN OTHER DAA COMBINATION THERAPIES ARE USED.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 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 
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