BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P120008 · Supplement: S003 · Decision Jun 12, 2013
    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
    ARCHITECT AFP,LN 3P36
    PMA Number
    P120008
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 12, 2013
    Date Received
    May 13, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE FOR THE ADDITION OF A QUALITY CONTROL TEST FOR PROTEIN PURITY OF INCOMING RAW MATERIAL (ALBUMIN BOVINE 30% SOLUTION WITH 0.1% SODIUM AZIDE (BOVINE ALBUMIN SOLUTION) USED IN THE MANUFACTURING OF CONTROLS AND CALIBRATORS FOR THE ARCHITECT AFP ASSAY. DUE TO THE RAW MATERIAL DISTRIBUTOR NOT HAVING A VALIDATED QUALITY CONTROL TEST FOR PROTEIN PURITY, THE ADDITIONAL QUALITY CONTROL TEST WILL BE IMPLEMENTED TO ENSURE THE PROTEIN PURITY OF THE RAW MATERIAL MEETS THE MANUFACTURERS SPECIFICATIONS.

    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