BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030024 · Supplement: S010 · Decision Sep 11, 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
    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR
    PMA Number
    P030024
    Supplement Number
    S010
    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
    September 11, 2009
    Date Received
    February 12, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE REVISION OF THE INTENDED USE TO INCLUDE USER OF THE VITROS 5600 INTEGRATED SYSTEM AND VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WITH THE ANTI-HBC ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CALIBRATOR AND IS INDICATED FOR: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK: FOR THE IN VITRO QUALITATIVE DETECTION OF TOTAL ANTIBODY (LGG AND IGM) TO HEPATITIS B CORE ANTIGEN(TOTAL ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA AND CITRATE) AND NEONATESERUM USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THELABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B, OR RECOVERY FROM HEPATITIS B INFECTION. THE PRESENCE OF ANTI-HBC MAY BE USED AS AN AID IN THE DETERMINATION OF EXPOSURE TOHBV INFECTION FOR INDIVIDUALS PRIOR TO HBV VACCINATION.VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CALIBRATOR:FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM FOR THE IN VITROQUALITATIVE DETECTION OF TOTAL ANTIBODY (IGG AND IGM) TO HEPATITIS B VIRUS CORE ANTIGEN (TOTAL ANTI HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA AND CITRATE) AND NEONATE SERUMUSING VITROS ANTI-HBC IGM REAGENT PACKS. THE VITROS ANTI-HBC CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS ECI/ECIQIMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600INTEGRATED SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACKS.

    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)