Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceVENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY
Generic NameImmunohistochemistry antibody assay, c-kit
Regulation Number864.1860
ApplicantVENTANA MEDICAL SYSTEMS, INC.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP020055
Date Received12/24/2002
Decision Date08/11/2004
Product Code NKF 
Docket Number 05M-0159
Notice Date 05/02/2005
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 
-
-