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 pd-l1(sp142) assay. The device is indicated for the following: ventana pd-l1 (sp142) assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-pd-l1 clone sp142 intended for use in the assessment of the pd-l1 protein in formalin-fixed, paraffin-embedded (ffpe) urothelial carcinoma tissue stained with optiview dab ihc detection kit and optiview amplifcation kit on a ventana benchmark ultra instrument. Pd-l1 status is determined by the proportion of tumor area occupied by pd-l1 expressing tumor-infiltrating immune cells (% ic) of any intensity. Pd-l1 expression in >= 5% ic determined by ventana pd-l1 (sp142) assay in urothelial carcinoma tissue is associated with increased objective response rate (orr) in a non-randomized study of tecentriq (atezolizumab).
| Device | VENTANA PD-L1(SP142) CDX ASSAY |
| Classification Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Generic Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. |
| Date Received | 2016-01-13 |
| Decision Date | 2016-05-18 |
| Notice Date | 2016-06-03 |
| PMA | P160002 |
| Supplement | S |
| Product Code | PLS |
| Docket Number | 16M-1400 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | VENTANA MEDICAL SYSTEMS, INC. 1910 East Innovation Park Dr. tucson, AZ 85755 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160002 | Original Filing | |
| S019 | 2022-10-14 | 30-day Notice |
| S018 | 2022-07-12 | 30-day Notice |
| S017 | 2022-02-16 | Special (immediate Track) |
| S016 | 2022-01-28 | 135 Review Track For 30-day Notice |
| S015 | 2021-09-07 | Special (immediate Track) |
| S014 | 2021-02-22 | Real-time Process |
| S013 | 2020-08-26 | Real-time Process |
| S012 | 2020-01-21 | Normal 180 Day Track |
| S011 | 2020-01-13 | Real-time Process |
| S010 | 2019-08-22 | Real-time Process |
| S009 | 2018-09-14 | Panel Track |
| S008 | ||
| S007 | 2018-06-18 | Real-time Process |
| S006 | 2018-06-14 | Normal 180 Day Track |
| S005 | ||
| S004 | ||
| S003 | 2017-07-17 | 30-day Notice |
| S002 | 2017-03-16 | Normal 180 Day Track No User Fee |
| S001 | 2016-09-01 | Normal 180 Day Track No User Fee |