BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    PMA: P140021 · Supplement: S005 · Decision Jul 25, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
    Trade Name
    ELECSYS ANTI-HCV II TEST SYSTEM
    PMA Number
    P140021
    Supplement Number
    S005
    Device Class
    FDA Class 2
    Product Code
    MZO
    Generic Name
    Assay, enzyme linked immunosorbent, hepatitis c virus
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 25, 2016
    Date Received
    January 29, 2016
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the migration of claims from the FDA approved Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV on the cobas e 601 immunoassay analyzer to the Modular ANALYTICS E170 analyzer. The device, as modified, will be marketed under the trade name Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV and is indicated for: Elecsys Anti-HCV II Immunoassay: Immunoassay for the in vitro qualitative detection of antibodies to hepatitis C virus (HCV) in human adult and pediatric (ages 18 months through 21 years) serum and plasma (potassium EDTA, lithium heparin, sodium heparin, and sodium citrate). Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test does not determine the state of infection or associated disease. The electrochemiluminescence immunoassay ECLIA is intended for use on the cobas e 601 and MODULAR ANALYTICS E170 immunoassay analyzers. Elecsys PreciControl Anti-HCV: Elecsys PreciControl Anti-HCV is used for quality control of the Elecsys Anti-HCV and the Elecsys Anti-HCV II immunoassays on the cobas e 601 and the MODULAR ANALYTICS E170 immunoassay analyzers.

    Classifications

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

    Product Code Device Name
    MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus