BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

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

    PMA: P060030 · Supplement: S027 · Decision Feb 14, 2013
    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, V2.0
    PMA Number
    P060030
    Supplement Number
    S027
    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
    Decision Code
    APPR
    Decision Date
    February 14, 2013
    Date Received
    July 2, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DEVICE DESIGN MODIFICATIONS TO REDUCE THE SAMPLE INPUT VOLUME, IMPROVE GENOTYPE INCLUSIVITY, AND IMPROVE ASSAY SENSITIVITY TO 15 IU/ML. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS® AMPLIPREP/COBAS® TAQMAN® HCV TEST, V2.0 AND IS INDICATED FOR: THE COBAS® AMPLIPREP/COBAS® TAQMAN® HCV TEST, V2.0 IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HEPATITIS C VIRAL (HCV) RNA GENOTYPES 1 TO 6 IN HUMAN EDTA PLASMA OR SERUM OF HCV-INFECTED INDIVIDUALS USING THE COBAS® AMPLIPREP INSTRUMENT FOR AUTOMATED SPECIMEN PROCESSING AND THE COBAS® TAQMAN® ANALYZER OR THE COBAS® TAQMAN® 48 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION. THE TEST IS INTENDED FOR USE INTHE MANAGEMENT OF PATIENTS WITH CHRONIC HCV IN CONJUNCTION WITH CLINICAL AND LABORATORY MARKERS OF INFECTION. THE TEST CAN BE USED TO PREDICT THE PROBABILITY OF SUSTAINED VIROLOGIC RESPONSE (SVR) EARLY DURING A COURSE OF ANTIVIRAL THERAPY, AND TO ASSESS VIRAL RESPONSE TO ANTIVIRAL TREATMENT (RESPONSE GUIDED THERAPY) AS MEASURED BY CHANGES OF HCV RNA LEVELS IN SERUM OR EDTA PLASMA. 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 STATE OF HCV INFECTION HAS NOT BEEN ESTABLISHED. THE COBAS® AMPLIPREP/ COBAS® TAQMAN® HCV TEST IS NOT INTENDED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF HCV IN BLOOD OR BLOOD PRODUCTS OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HCV INFECTION.

    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