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    FDA PMA FDA Class 2 Approved (Withdrawn) 🇺🇸 United States

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

    PMA: P020022 · Decision Mar 28, 2003
    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
    BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)
    PMA Number
    P020022
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    March 28, 2003
    Date Received
    June 19, 2002
    Expedited Review
    Y
    Docket Number
    04M-0538

    Advisory Committee Statement

    APPROVAL FOR THE BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA). THE DEVICE IS INDICATED FOR: THE VERSANT HCV RNA 3.0 ASSAY (BDNA) IS A SIGNAL AMPLIFICATION NUCLEIC ACID PROBE ASSAY FOR THE QUANTITATION OF HUMAN HEPATITIS C VIRAL RNA (HCV RNA) IN THE SERUM OR PLASMA (EDTA AND ACD) OF HCV-INFECTED INDIVIDUALS USING THE BAYER SYSTEM 340 BDNA ANALYZER. SPECIMENS CONTAINING HCV GENOTYPES 1-6 HAVE BEEN VALIDATED FOR QUANTITATION IN THE ASSAY. THE VERSANT HCV RNA 3.0 ASSAY IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED PATIENTS UNDERGOING ANTI-VIRAL THERAPY. THE ASSAY MEASURES HCV RNA LEVELS AT BASELINE AND DURING TREATMENT AND ARE USEFUL IN PREDICTING NON-RESPONSE TO HCV THERAPY, AND ARE PREDICTIVE OF NON-SUSTAINED VIROLOGICAL RESPONSE. THE RESULTS FROM THE VERSANT HCV RNA 3.0 ASSAY (BDNA) MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS. ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED ONLY FOR INDIVIDUALS TREATED WITH INTERFERON ALFA-2B PLUS RIBAVIRIN. NO INFORMATION IS AVAILABLE ON THE ASSAY PREDICTIVE VALUES WHEN OTHER 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