BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Antibody Assay, C-Kit

    PMA: P020055 · Decision Aug 11, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Immunohistochemistry Antibody Assay, C-Kit
    Trade Name
    VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY
    PMA Number
    P020055
    Device Class
    FDA Class 3
    Product Code
    NKF
    Generic Name
    Immunohistochemistry antibody assay, c-kit
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 11, 2004
    Date Received
    December 24, 2002
    Expedited Review
    N
    Docket Number
    05M-0159

    Advisory Committee Statement

    APPROVAL FOR THE VENTANA MEDICAL SYSTEMS' PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY. THE DEVICE IS INDICATED AS FOLLOWS: VENTANA MEDICAL SYSTEMS' PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY IS INTENDED FOR LABORATORY USE, VIA LIGHT MICROSCOPY, FOR THE QUALITATIVE DETECTION OF KIT PROTEIN IN FORMALIN-FIXED, PARAFFIN-EMBEDDED GASTROINTESTINAL STROMAL TUMORS (GISTS) USING EITHER AN AUTOMATED IMMUNOHISTOCHEM-ISTRY STAINING SYSTEM OR A MANUAL ASSAY. IT IS INDICATED AS AN AID IN THE DIAGNOSIS OF GIST WITHIN THE CONTEXT OF THE PATIENT'S CLINICAL HISTORY, TUMOR MORPHOLOGY, AND OTHER DIAGNOSTIC TESTS EVALUATED BY A QUALIFIED PATHOLOGIST. IT MAY BE USED AFTER THE DIAGNOSIS OF GIST AS AN AID IN THE SELECTION OF GIST PATIENTS WHO MAY QUALIFY FOR IMATINIB MESYLATE (GLEEVEC ) THERAPY. PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY IS OPTIMIZED FOR USE ON VENTANA AUTOMATED SLIDE STAINER AND FOR MANUAL APPLICATION IN COMBINATION WITH VENTANA MEDICAL SYSTEMS' IVIEW DAB DETECTION KIT AND ACCESSORIES. THE CLINICAL INTERPRETATION OF ANY STAINING, OR THE ABSENCE OF STAINING, MUST BE COMPLEMENTED BY MORPHOLOGICAL STUDIES AND EVALUATION OF PROPER CONTROLS. EVALUATION MUST BE MADE BY A QUALIFIED PATHOLOGIST WITHIN THE CONTEXT OF THE PATIENT'S CLINICAL HISTORY AND OTHER DIAGNOSTIC TESTS.

    Classifications

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

    Product Code Device Name
    NKF Immunohistochemistry Antibody Assay, C-Kit