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

    Enzyme Immunoassay, Fetal Fibronectin

    PMA: P920048 · Supplement: S008 · Decision Jul 24, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Enzyme Immunoassay, Fetal Fibronectin
    Trade Name
    RAPID FFN CONTROL KIT
    PMA Number
    P920048
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    LKV
    Generic Name
    ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 24, 2014
    Date Received
    June 24, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO ADD AN INTERMEDIATE SOLUTION IN THE MANUFACTURING PROCESS OF POSITIVE REFERENCE CALIBRATOR, TO MODIFY THE PERSONNEL IN CHARGE OF IN-PROCESS MANUFACTURING TESTING AND TO INCREASE THE NUMBER OF REPLICATES IN BULK SOLUTION CONCENTRATION VERIFICATION PROCEDURE FOR BOTH POSITIVE REFERENCE CALIBRATOR AND POSITIVE CONTROL. THE POSITIVE REFERENCECALIBRATOR AND THE POSITIVE CONTROL ARE COMPONENTS OF THE RAPID FFN CONTROL KIT FOR USE WITH THE TLIIQ ANALYZER AND FFN ELISA TEST.

    Classifications

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

    Product Code Device Name
    LKV Enzyme Immunoassay, Fetal Fibronectin