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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceC-KIT PHARMDX
Classification Nameimmunohistochemistry antibody assay, c-kit
Generic Nameimmunohistochemistry antibody assay, c-kit
Regulation Number864.1860
Applicant
DAKO NORTH AMERICA, INC.
6392 via real
carpinteria, CA 93013
PMA NumberP040011
Date Received03/12/2004
Decision Date06/27/2005
Product Code
NKF[ Registered Establishments with NKF ]
Docket Number 05M-0388
Notice Date 09/23/2005
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Approval Order 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...
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 
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