BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P970037 · Supplement: S003 · Decision Jan 12, 2011
    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
    AUTODELFIA XPRESS HAFP TEST SYSTEM
    PMA Number
    P970037
    Supplement Number
    S003
    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
    January 12, 2011
    Date Received
    March 1, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO EXTEND THE AUTODELFIA HAFP KIT ONTO THE DELFIA XPRESS INSTRUMENT. THE MODIFIED VERSION, NAMELY, DELFIA XPRESS HAFP KIT IS DESIGNED TO BE USED WITH THE 6000 DELFIA XPRESS CLINICAL RANDOM ACCESS SCREENING PLATFORM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DELFIA XPRESS HAFP KIT AND IS INDICATED FOR `THE QUANTITATIVE DETERMINATION OF HUMAN ALPHA-FETOPROTEIN (AFP) IN MATERNAL SERUM AND AMNIOTIC FLUID OBTAINED BETWEEN THE 15TH AND 20TH WEEKS OF GESTATION. THE ASSAY IS TO BE PERFORMED ON THE 6000 DELFIA XPRESS CLINICAL RANDOM ACCESS SCREENING PLATFORM AND IS INTENDED FOR USE ONLY IN CONJUNCTION WITH OTHER DIAGNOSTIC TOOLS SUCH AS ULTRASOUND AND AMNIOGRAPHY AS AN AID IN THE DETECTION OF OPEN NEURAL TUBE DEFECTS (ONTDS).

    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