BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P080023 · Decision Apr 10, 2009
    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 REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS
    PMA Number
    P080023
    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
    April 10, 2009
    Date Received
    August 28, 2008
    Expedited Review
    N
    Docket Number
    09M-0244

    Advisory Committee Statement

    APPROVAL FOR THE ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS. THESE DEVICES ARE INDICATED FOR:ARCHITECT CORE REAGENT KIT:THE ARCHITECT CORE ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY(CMIA) FOR THE QUALITATIVE DETECTION OF IGG AND IGM ANTIBODIES TO HEPATITIS B COREANTIGEN (ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (DIPOTASSIUM EDTA,LITHIUM HEPARIN, SODIUM HEPARIN) AND NEONATAL SERUM. IT IS INTENDED AS AN AID IN THE DIAGNOSIS OF ACUTE, CHRONIC, OR RESOLVED HEPATITIS B VIRUS (HBV) INFECTION IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION.ARCHITECT CORE CALIBRATOR:THE ARCHITECT CORE CALIBRATOR IS USED FOR THE CALIBRATION OF THE ARCHITECT ISYSTEM WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF IGG AND IGM ANTIBODIES TOHEPATITIS B CORE ANTIGEN (ANTI-HBC) WITH THE ARCHITECT CORE REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT CORE CALIBRATOR HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBC ASSAYS.ARCHITECT CORE CONTROLS:THE ARCHITECT CORE CONTROLS ARC USED FOR MONITORING THE PERFORMANCE OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUALITATIVE DETECTION OF IGG AND IGM ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) WITH THE ARCHITECT CORE REAGENT KIT. THEPERFORMANCE OF THE ARCHITECT CORE CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHERANTI-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)