BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    PMA: P150015 · Decision Oct 14, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
    Trade Name
    COBAS HCV TEST
    PMA Number
    P150015
    Device Class
    FDA Class 2
    Product Code
    MZP
    Generic Name
    Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
    Regulation Number
    866.3170
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    October 14, 2015
    Date Received
    April 27, 2015
    Expedited Review
    N
    Docket Number
    15M-4018

    Advisory Committee 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.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus