BEUDAMED
    FDA PMA Approved (Withdrawn) 🇺🇸 United States

    PMA: P990044 · Decision Mar 30, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
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    Basic Information

    Trade Name
    DIASORIN ETI-CORE-IGMK PLUS ASSAY
    PMA Number
    P990044
    Advisory Committee
    Microbiology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    March 30, 2001
    Date Received
    July 2, 1999
    Expedited Review
    N
    Docket Number
    01M-0455

    Advisory Committee Statement

    APPROVAL FOR THE DIASORIN ETI-CORE-IGMK PLUS ASSAY. THE DEVICE IS INDICATED FOR: ETI-CORE-IGMK PLUS IS AN IN VITRO ENZYME IMMUNOASSAY(EIA) INTENDED FOR USE IN THE QUALITATIVE DETERMINATION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (IGM ANTI-HBC) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN). THE ETI-CORE-IGMK PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT. THE PRESENCE OF IGM ANTI-HBC, IN THE PRESENCE OF TOTAL ANTIBODY TO HBC (ANTI-HBC) IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR ACUTE INFECTION. THE ABSENCE OF IGM ANTI-HBC, IN THE PRESENCE OF TOTAL ANTI-HBC, IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR RECOVERY FROM HBV INFECTION. FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ETI-CORE-IGMK PLUS ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY. THIS ASSAY HAS NOT BEEN FDA-APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS.