BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030040 · Supplement: S011 · Decision Dec 25, 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
    ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
    PMA Number
    P030040
    Supplement Number
    S011
    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 25, 2016
    Date Received
    July 5, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a claim to test a pediatric population with the FDA approved ADVIA Centaur® HBc IgM ReadyPack Reagents and ADVIA Centaur® HBc IgM Quality Control Materials. The device, as modified, will be marketed under the trade name ADVIA Centaur® HBc IgM Assay and is indicated for:ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systemsThe ADVIA Centaur® HBc IgM (aHBcM) assay is an in vitro diagnostic test for the qualitative determination of lgM response to hepatitis B virus core antigen in human pediatric (2 through 21 years) and adult serum and plasma (EDTA or lithium or sodium heparinized) using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. The assay uses recombinant HBc antigen. This assay may be used in combination with other hepatitis B virus (HBV) marker assays to define the clinical status of known HBV infected patients or can be combined with other HBV, HAV (hepatitis A virus), and HCV (hepatitis C virus) assays for the diagnosis of patients presenting symptoms of acute viral hepatitis.Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age. Assay performance characteristics have not been established when the ADVIA Centaur HBc IgM assay is used in conjunction with other manufacturers' assays for specific HBV serological markers.ADVIA Centaur CP systemThe ADVIA Centaur® HBc IgM assay is an in vitro diagnostic test for the qualitative determination of IgM response to hepatitis B virus core antigen in human pediatric (2 through 21 years) and adult serum and plasma (EDTA or lithium or sodium heparinized) using the ADVIA Centaur CP System. The assay uses recombinant HBc antigen. This assay may be used in combination with other hepatitis B virus (HBV) marker assays to define the clinical status of known HBV infected patients or can be combined with other HBV, HAV (hepatitis A virus), and HCV (hepatitis C virus) assays for the diagnosis of patients presenting symptoms of acute viral hepatitis.Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age.Assay performance characteristics have not been established when the ADVIA Centaur HBc IgM assay is used in conjunction with other manufacturers' assays for specific HBV serological markers.ADVIA Centaur® HBc IgM Quality Control MaterialsFor monitoring the performance of the HBc IgM assay using the ADVIA Centaur® systems. The performance of the HBc IgM quality control material has not been established with any other anti-HBc IgM assays.

    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)