BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Kit, Test,Alpha-Fetoprotein For Testicular Cancer

    PMA: P820060 · Supplement: S016 · Decision Feb 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Kit, Test,Alpha-Fetoprotein For Testicular Cancer
    Trade Name
    ABBOTT ARCHITECT AFP FOR THE ARCHITECT I2000SR ANALYZER
    PMA Number
    P820060
    Supplement Number
    S016
    Device Class
    FDA Class 2
    Product Code
    LOJ
    Generic Name
    KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 2, 2004
    Date Received
    November 26, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF THE ABBOTT ARCHITECT AFP ASSAY ON THE ARCHITECT I2000SR ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABBOTT ARCHITECT AFP ASSAY FOR THE ARCHITECT I2000 ANALYZER AND IS INDICATED FOR THE FOLLOWING: 1) HUMAN SERUM OR PLASMA TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOSUS TESTICULAR CANCER. 2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION TO AID IN THE DETECTION OF 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.

    Classifications

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

    Product Code Device Name
    LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer