BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Enzyme Immunoassay, Fetal Fibronectin

    PMA: P920048 · Supplement: S009 · Decision Jun 24, 2015
    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 TLIIQ SYSTEM
    PMA Number
    P920048
    Supplement Number
    S009
    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
    June 24, 2015
    Date Received
    April 9, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF A NEW RESIN IN THE PLASMA FIBRONECTIN (PFN) AFFINITY COLUMN USED TO PURIFY THE A120 FETAL FIBRONECTIN SPECIFIC ANTIBODY CONTAINED IN THE RAPID FFN TEST FOR THE TLIIQ SYSTEM. ADDITIONALLY, THE IMPLEMENTATION OF A MODIFIED ARGININE CONTAINING NEUTRALIZATION BUFFER TO DECREASE PRECIPITATION OF THE A120 ANTIBODY FROM THE BUFFER.

    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