This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for modifying the intended use of the ventana pd-l1(sp142). The 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 and non-small cell lung cancer (nsclc) tissue stained with optiview dab ihc detection kit and optiview amplification kit on a ventana benchmark ultra instrument. Determination of pd-l1 status is indication-specific, and evaluation is based on either the proportion of tumor area occupied by pd-l1 expressing tumor-infiltrating immune cells (% ic) of any intensity or the percentage of pd-l1 expressing tumor cells (% tc) of any intensity. Pd-l1 expression in >= 5% ic determined by ventana pd-l1 (sp142) assay in urothelial carcinoma tissue is indicated as an aid in identifying urothelial carcinoma patients for treatment with tecentriq (atezolizumab). Pd-l1 expression in >= 50% tc or >= 10% ic determined by ventana pd-l1 (sp142) assay in nsclc tissue may be associated with enhanced overall survival from tecentriq (atezolizumab). See the tecentriq® product label for pd-l1 expression cutoff values guiding therapy in specific clinical circumstances. This product is intended for in vitro diagnostic (ivd) use.
| 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 | 2018-06-14 |
| Decision Date | 2018-07-02 |
| PMA | P160002 |
| Supplement | S006 |
| Product Code | PLS |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | VENTANA MEDICAL SYSTEMS, INC. 1910 East Innovation Park Dr. tucson, AZ 85755 |
| 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 |