BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P060035 · Decision Nov 6, 2007
    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
    ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS
    PMA Number
    P060035
    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
    November 6, 2007
    Date Received
    December 1, 2006
    Expedited Review
    N
    Docket Number
    07M-0447

    Advisory Committee Statement

    APPROVAL FOR THE ARCHITECT CORE-M REAGENT KITARCHITECT CORE-M CALIBRATORS ANDARCHITECT CORE-M CONTROLS. THE DEVICES IS INDICTED FOR: THE ARCHITECT CORE-M ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (IGM ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM OR PLASMA (DIPOTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN) AND NEONATAL SERUM. A TEST FOR IGM ANTI-HBC IS INDICATED AS AN AID IN THE DIAGNOSIS OF ACUTE OR RECENT HEPATITIS B VIRUS (HBV) INFECTION IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION. THE ARCHITECT CORE-M CALIBRATORS ARE USED FOR THE CALIBRATION OF THE ARCHITECT I SYSTEM WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (IGM ANTI-HBC) USING THE ARCHITECT CORE-M REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT CORE-M CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER IGM ANTI-HBC ASSAYS. THE ARCHITECT CORE-M CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (IGM ANTI-HBC) IN HUMAN ADULT SERUM AND PLASMA WHEN USING THE ARCHITECT CORE-M REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT CORE-M CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER IGM ANTI-HBC 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)