BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

    PMA: P050045 · Decision Jan 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion
    Trade Name
    DAKO TOP2A FISH PHARMDX KIT
    PMA Number
    P050045
    Device Class
    FDA Class 3
    Product Code
    NXG
    Generic Name
    Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    January 11, 2008
    Date Received
    November 30, 2005
    Expedited Review
    N
    Docket Number
    08M-0182

    Advisory Committee Statement

    APPROVAL FOR THE TOP2A FISH PHARMDX KIT. THE DEVICE IS INDICATED FOR: TOP2A FISH PHARMDX KIT IS DESIGNED TO DETECT AMPLIFICATIONS AND DELETIONS (COPY NUMBER CHANGES) OF THE TOP2A GENE USING FLUORESCENCE IN SITU HYBRIDIZATION (FISH) TECHNIQUE ON FORMALIN-FIXED, PARAFFIN-EMBEDDED HUMAN BREAST CANCER TISSUE SPECIMENS. DELETIONS AND AMPLIFICATIONS OF THE TOP2A GENE SERVE AS A MARKER FOR POOR PROGNOSIS IN HIGH-RISK BREAST CANCER PATIENTS. RESULTS FROM THE TOP2A FISH PHARMDX KIT ARE INTENDED FOR USE AS AN ADJUNCT TO EXISTING CLINICAL AND PATHOLOGICAL INFORMATION.

    Classifications

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

    Product Code Device Name
    NXG Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion