BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P820060 · Supplement: S024 · Decision Feb 26, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
    Trade Name
    ABBOTT AFP-EIA
    PMA Number
    P820060
    Supplement Number
    S024
    Device Class
    FDA Class 3
    Product Code
    LOK
    Generic Name
    KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 26, 2010
    Date Received
    November 20, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES IN SOFTWARE THAT AFFECTED PATIENT RESULTS REPORTING FOLLOWING AUTOMATED DILUTION. THE LOW CONCENTRATION LIMIT FLAG FOR THE 1:101 AUTOMATED DILUTION PROTOCOL WITHIN THE AXSYM AFP ASSAY FILE WAS CHANGED FROM 0 NG/ML ON AXSYM CANCER ASSAY DISK VERSION 6, LN 3D50-06. THE CHANGE IN QUESTION MANDATES THAT PATIENT RESULTS ARE FLAGGED, FOLLOWING AUTO-DILUTION, WHEN THE CALCULATED VALUES OF THE UNDILUTED SAMPLE FALL BELOW 40.40 NG/ML AND THE MEASURED VALUE OF THE DILUTED SAMPLE FALLS BELOW 0.40 NG/ML.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects