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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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 S003 
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