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.
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.
| Device | VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY |
| Generic Name | Immunohistochemistry Antibody Assay, C-kit |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. |
| Date Received | 2002-12-24 |
| Decision Date | 2004-08-11 |
| Notice Date | 2005-05-02 |
| PMA | P020055 |
| Supplement | S |
| Product Code | NKF |
| Docket Number | 05M-0159 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | VENTANA MEDICAL SYSTEMS, INC. 1910 E. Innovation Park Dr. tucson, AZ 85755 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020055 | Original Filing | |
| S028 | 2022-10-14 | 30-day Notice |
| S027 | 2022-07-12 | 30-day Notice |
| S026 | 2022-02-16 | Special (immediate Track) |
| S025 | 2022-01-28 | 135 Review Track For 30-day Notice |
| S024 | 2021-02-22 | Real-time Process |
| S023 | 2020-08-26 | Real-time Process |
| S022 | 2020-01-13 | Real-time Process |
| S021 | ||
| S020 | 2017-07-17 | 30-day Notice |
| S019 | 2016-11-15 | Normal 180 Day Track |
| S018 | 2015-12-10 | 135 Review Track For 30-day Notice |
| S017 | 2015-08-26 | 30-day Notice |
| S016 | 2014-10-27 | 30-day Notice |
| S015 | 2014-06-16 | 135 Review Track For 30-day Notice |
| S014 | 2014-02-06 | Real-time Process |
| S013 | 2014-01-06 | 30-day Notice |
| S012 | 2013-11-12 | 30-day Notice |
| S011 | 2013-10-28 | 30-day Notice |
| S010 | 2013-10-11 | Normal 180 Day Track |
| S009 | 2013-08-30 | 30-day Notice |
| S008 | 2013-05-06 | Real-time Process |
| S007 | 2013-04-17 | 30-day Notice |
| S006 | 2013-03-04 | 30-day Notice |
| S005 | 2012-12-11 | Real-time Process |
| S004 | 2012-08-31 | Real-time Process |
| S003 | 2012-06-26 | 30-day Notice |
| S002 | 2011-05-23 | Normal 180 Day Track |
| S001 | 2007-04-16 | 30-day Notice |