BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

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

    PMA: P060007 · Decision Sep 7, 2006
    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 HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT
    PMA Number
    P060007
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    September 7, 2006
    Date Received
    February 24, 2006
    Expedited Review
    N
    Docket Number
    07M-0152

    Advisory Committee Statement

    APPROVAL FOR THE ARCHITECT HBSAG REAGENTS, ARCHITECT HBSAG CALIBRATORS, ARCHITECT HBSAG CONTROLS, ARCHITECT HBSAG CONFIRMATORY REAGENTS, AND ARCHITECT HBSAG CONFIRMATORY MANUAL DILUENT. THE ARCHITECT HBSAG ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (DIPOTASSIUM EDTA). THE ASSAY MAY ALSO BE USED TO SCREEN FOR HBV INFECTION IN PREGNANT FEMALES TO IDENTIFY NEONATES WHO ARE AT RISK OF ACQUIRING HEPATITIS B DURING THE PERINATAL PERIOD. ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH THE HEPATITIS B VIRUS (HBV) (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS B INFECTION. THE ARCHITECT HBSAG CALIBRATORS ARE USED FOR CALIBRATION OF THE ARCHITECT I SYSTEM WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) USING THE ARCHITECT HBSAG AND HBSAG CONFIRMATORY REAGENT KITS. THE PERFORMANCE OF THE ARCHITECT HBSAG CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER HBSAG ASSAYS. (CONTINUED...)

    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)