BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    PMA: P160019 · Decision Dec 23, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
    Trade Name
    Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
    PMA Number
    P160019
    Device Class
    FDA Class 3
    Product Code
    LOM
    Generic Name
    Test, hepatitis b (b core, be antigen, be antibody, b core igm)
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 23, 2016
    Date Received
    July 1, 2016
    Expedited Review
    N
    Docket Number
    16M-4530

    Advisory Committee Statement

    Approval for the Elecsys Hbsag II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II. This device is indicated for:Elecsys HBsAg II Immunoassay for the in vitro qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric (2 to 21 years of age) serum and plasma (sodium heparin, lithium heparin, K2 EDTA, sodium citrate). Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals at risk for infection with HBV or with signs and symptoms of hepatitis. In addition, this assay may be used to screen for hepatitis B infection in pregnant women to identify neonates at high risk of acquiring HBV during the perinatal period.The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 601 immunoassay analyzer.Elecsys HBsAg Confirmatory TestFor Elecsys HBsAg Confirmatory Test used with Elecsys HBsAg immunoassay:Immunoassay for in vitro qualitative confirmation of the presence of hepatitis B surface antigen in human serum and plasma (sodium heparin, K3 EDTA, sodium citrate) samples repeatedly reactive when tested with the Elecsys HBsAg immunoassay. This assay is intended for use on the Elecsys and cobas e immunoassay analyzers.For Elecsys HBsAg Confirmatory Test used with Elecsys HBsAg II:Immunoassay for in vitro qualitative confirmation of the presence of hepatitis B surface antigen in human serum and plasma (sodium heparin, lithium heparin, K2 EDTA, sodium citrate) samples repeatedly reactive when tested with Elecsys HBsAg II. This assay is intended for use on the cobas e 601 immunoassay analyzer.PreciControl HBsAg IIPreciControl HBsAg II is used for quality control of the Elecsys HBsAg II immunoassay on the cobas e 601 immunoassay analyzer. The performance of PreciControl HBsAg II has not been established with any other HBsAg assay.

    Classifications

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

    Product Code Device Name
    LOM Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)