BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P120008 · Decision Nov 28, 2012
    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 ARCHITECT AFP ASSAY
    PMA Number
    P120008
    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
    November 28, 2012
    Date Received
    May 1, 2012
    Expedited Review
    N
    Docket Number
    12M-1176

    Advisory Committee Statement

    APPROVAL FOR THE ARCHITECT AFP ASSAY, ARCHITECT AFP CALIBRATORS AND ARCHITECT AFP CONTROLS. THIS DEVICE IS INDICATED FOR:THE ARCHITECT AFP ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN:1) HUMAN SERUM OR PLASMA TO AID IN MONITORING DISEASE PROGRESSION DURING THE COURSE OF DISEASE AND TREATMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER; AND 2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (NTD). TEST RESULTS WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY OR AMNIOGRAPHY ARE A SAFE AND EFFECTIVE AID IN THE DETECTION OF FETAL OPEN NTD. THE ARCHITECT AFP CALIBRATORS ARE FOR THE CALIBRATION OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID. THE PERFORMANCE OF THE ARCHITECT AFP CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER AFP ASSAYS. THE ARCHITECT AFP CONTROLS ARE FOR THE ESTIMATION OF TEST PRECISION AND THE DETECTION OF SYSTEMATIC ANALYTICAL DEVIATIONS OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID. THE PERFORMANCE OF THE ARCHITECT AFP CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER AFP ASSAYS.

    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