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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Immunohistochemistry Antibody Assay, C-Kit

    PMA: P040011 · Decision Jun 27, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Immunohistochemistry Antibody Assay, C-Kit
    Trade Name
    C-KIT PHARMDX
    PMA Number
    P040011
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    June 27, 2005
    Date Received
    March 12, 2004
    Expedited Review
    N
    Docket Number
    05M-0388

    Advisory Committee Statement

    APPROVAL FOR THE DAKOCYTOMATION C-KIT PHARMDX. DAKOCYTOMATION C-KIT PHARMDX ON THE DAKO AUTOSTAINER: THE C-KIT PHARMDX ASSAY IS A QUALITATIVE IMMUNOHISTOCHEMICAL (IHC) KIT SYSTEM USED ON THE DAKO AUTOSTAINER, FOR THE IDENTIFICATION OF C-KIT PROTEIN/CD117 ANTIGEN (C-KIT PROTEIN) EXPRESSION IN NORMAL AND NEOPLASTIC FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUES FOR HISTOLOGICAL EVALUATION. THE C-KIT PHARMDX RABBIT POLYCLONAL ANTIBODIES SPECIFICALLY DETECT THE C-KIT PROTEIN IN CD117 ANTIGEN-EXPRESSING CELLS. THE C-KIT PHARMDX IS INDICATED AS AN AID IN THE DIFFERENTIAL DIAGNOSIS OF GASTROINTESTINAL STROMAL TUMORS (GIST). AFTER DIAGNOSIS OF GIST, RESULTS FROM C-KIT PHARMDX MAY BE USED AS AN AID IN IDENTIFYING THOSE PATIENTS ELIGIBLE FOR TREATMENT WITH GLEEVEC/GLIVEC (IMATINIB MESYLATE). RESULTS FROM HEMATOXYLIN AND EOSIN (H&E) STAINS AND A PANEL OF ANTIBODIES CAN AID IN THE DIFFERENTIAL DIAGNOSIS OF GIST. INTERPRETATION MUST BE MADE BY A QUALIFIED PATHOLOGIST, WITHIN THE CONTEXT OF A PATIENT'S CLINICAL HISTORY, PROPER CONTROLS, AND OTHER DIAGNOSTIC TEST. DAKO CYTOMATION C-KIT PHARMDX FOR MANUAL USE: THE C-KIT PHARMDX ASSAY IS A QUALITATIVE IMMUNOHISTOCHEMICAL (IHC) KIT SYSTEM USED FOR THE IDENTIFICATION OF C-KIT PROTEIN/CD117 ANTIGEN (C-KIT PROTEIN) EXPRESSION IN NORMAL AND NEOPLASTIC FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUES FOR HISTOLOGICAL EVALUATION. THE C-KIT PHARMDX RABBIT POLYCLONAL. ANTIBODIES SPECIFICALLY DETECT THE C-KIT PROTEIN IN CD117 ANTIGEN-EXPRESSING CELLS. THE C-KIT PHARMDX IS INDICATED AS AN AID IN THE DIFFERENTIAL DIAGNOSIS OF GASTROINTESTINAL STROMAL TUMORS (GIST). AFTER DIAGNOSIS OF GIST, RESULTS FROM C-KIT PHARMDX MAY BE USED AS AN AID IN IDENTIFYING THOSE PATIENTS ELIGIBLE FOR TREATMENT WITH GLEEVEC/GLIVEC (IMATINIB MESYLATE). RESULTS FROM HEMATOXYLIN AND EOSIN (H&E) STAINS AND A PANEL OF ANTIBODIES CAN AID IN THE DIFFERENTIAL DIAGNOSIS OF GIST. INTERPRETATION MUST BE MADE BY A QUALIFIED PATHOLOGIST, WITHIN THE CONTEXT OF A PATIENT'S...

    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