BEUDAMED
    FDA PMA Approved (Withdrawn) 🇺🇸 United States

    PMA: P990041 · Decision Mar 30, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
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    Basic Information

    Trade Name
    DIASORIN ETI-AB-EBK PLUS ASSAY
    PMA Number
    P990041
    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    Approved (Withdrawn)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-0452

    Advisory Committee Statement

    APPROVAL FOR THE DIASORIN ETI-AB-EBK PLUS ASSAY. THE DEVICE IS INDICATED FOR: ETI-AB-EBK PLUS IS AN IN VITRO ENZYME IMMUNOASSAY (EIA) INTENDED FOR USE IN THE QUALITATIVE DETECTION OF TOTAL ANTIBODIES TO HEPATITIS B E ANTIGEN (ANTI-HBE) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN). THE ETI-AB-EBK PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT. THE DETECTION OF ANTI-HBE IS INDICATIVE OF LABORATORY DIAGNOSIS FOR SEROCONVERSION AND PROGRESSION TO HEPATITIS B VIRUS (HBV) CLEARANCE. A REACTIVE TEST IS PRESUMPTIVE LABORATORY EVIDENCE OF HBV SEROCONVERSION. FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ANTI-HBE ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.