BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Enzyme Immunoassay, Fetal Fibronectin

    PMA: P920048 · Supplement: S003 · Decision Mar 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Enzyme Immunoassay, Fetal Fibronectin
    Trade Name
    RAPID FFN FOR THE TLI SYSTEM
    PMA Number
    P920048
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    LKV
    Generic Name
    ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 9, 2001
    Date Received
    September 11, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING: 1) A CHANGE IN THE CALIBRATION PROCEDURE THAT ALLOWS FOR EXTENDED CALIBRATION, ACCOMPLISHED WITH A SOFTWARE MODIFICATION AND NO LONGER REQUIREING THE USE OF THE FFN POSITIVE REFERENCE CALIBRATOR; AND 2) THE ADDITION OF A QUALITY CONTROL COMPONENT, THE TLI QC CASSETTE, FOR THE TLI ANALYZER COUPLED WITH A DECREASE IN FREQUENCY OF TESTING LIQUID CONTROLS.

    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