BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P110029 · Decision Apr 12, 2012
    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 QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
    PMA Number
    P110029
    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 12, 2012
    Date Received
    July 26, 2011
    Expedited Review
    N
    Docket Number
    12M-0372

    Advisory Committee Statement

    APPROVAL FOR THE ARCHITECT HBSAG QUALITATIVE, ARCHITECT HBSAG QUALITATIVE CONFIRMATORY, ARCHITECT HBSAG QUALITATIVE CONFIRMATORY MANUAL DILUENT, ARCHITECT HBSAG QUALITATIVE CALIBRATORS, AND ARCHITECT HBSAG QUALITATIVE CONTROLS. THIS DEVICE IS INDICATED FOR: ARCHITECT HBSAG QUALITATIVE - THE ARCHITECT HBSAG QUALITATIVE 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 AND NEONATE SERUM. THE ASSAY MAY ALSO BE USED TO SCREEN FOR HBV INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT RISK FOR ACQUIRING HEPATITIS BDURING 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. NOT INTENDED FOR USE IN SCREENING BLOOD, PLASMA, OR TISSUE DONORS. ARCHITECT HBSAG QUALITATIVE CONFIRMATORY - THE ARCHITECT HBSAG QUALITATIVE CONFIRMATORY ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA AND NEONATE SERUM BY MEANS OF SPECIFIC ANTIBODY NEUTRALIZATION. 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. NOT INTENDED FOR USE IN SCREENING BLOOD, PLASMA, OR TISSUE DONORS. (FOR ADDITIONAL INFORMATION, PLEASE REFER TO APPROVAL ORDER).

    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)