BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P110041 · Decision May 16, 2014
    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 HBSAGII
    PMA Number
    P110041
    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
    May 16, 2014
    Date Received
    December 19, 2011
    Expedited Review
    N
    Docket Number
    14M-0692

    Advisory Committee Statement

    APPROVAL FOR THE ADVIA CENTAUR HBSAGII, ADVIA CENTAUR HBSAG CONFIRMATORY, AND ADVIA CENTAUR HBSAG QUALITYCONTROL MATERIAL. THIS DEVICE IS INDICATED FOR:ADVIA CENTAUR HBSAGII (HBSII) -THE ADVIA CENTAUR HBSAGII (HBSII) ASSAY IS AN IN VITRO IMMUNOASSAY FOR THE QUALITATIVEDETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM AND PLASMA (EDT A, LITHIUM-HEPARIN, OR SODIUM-HEPARIN), AND NEONATAL SAMPLES USINGTHE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY MAY BE USED IN CONJUNCTIONWITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO DIAGNOSE INDIVIDUALS WITH ACUTE OR CHRONICHEPATITIS B INFECTION. THE ASSAY MAY ALSO BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT RISK OF ACQUIRING HEPATITIS B DURING THE PERINATAL PERIOD.ADVIA CENTAUR HBSAG CONFIRMATORYTHE ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY IS AN IN VITRO IMMUNOASSAY FOR THE CONFIRMATION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUMEDTA, LITHIUM-HEPARIN, OR SODIUM-HEPARIN), AND NEONATAL SAMPLES USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY IS INTENDED TO BE USED TO CONFIRM THE PRESENCE OFHBSAG IN SAMPLES THAT ARE REPEATEDLY REACTIVE USING THE ADVIA CENTAUR HBSAGII ASSAY.ADVIA CENTAUR HBSAG QUALITY CONTROL MATERIALFOR MONITORING THE PERFORMANCE OF THE HBSAG, HBSAGII AND HBSAG CONFIRMATORY ASSAYS ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HBSAG QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER HBSAG OR HBSAG CONFIRMATORY 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)