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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.
Classification Nameimmunohistochemistry antibody assay, c-kit
Generic Nameimmunohistochemistry antibody assay, c-kit
Regulation Number864.1860
1910 e. innovation park dr.
tucson, AZ 85755
PMA NumberP020055
Date Received12/24/2002
Decision Date08/11/2004
Product Code
NKF[ Registered Establishments with NKF ]
Docket Number 05M-0159
Notice Date 05/02/2005
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Approval Order 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018