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: P060030 · Decision Oct 30, 2008
    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 AMPLIPREP/COBAS TAQMAN HCV TEST
    PMA Number
    P060030
    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 30, 2008
    Date Received
    October 27, 2006
    Expedited Review
    N
    Docket Number
    09M-0033

    Advisory Committee 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."

    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