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.
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 programmed death-ligand 1 (pd-l1) protein in tumor cells and tumor-infiltrating immune cells in the formalin-fixed, paraffin-embedded (ffpe) tissues indicated below 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. Ventana pd-l1 (sp142) assay is indicated as an aid for identifying patients for treatment with the therapies for the respective cutoffs listed in table 1 in accordance with the approved therapeutic product labeling. Table 1. Companion diagnostic indications for the ventana pd-l1 (sp142) assay indication for use therapy cutoff urothelial carcinoma tecentriq? 5% ictriple-negative breast carcinoma (tnbc) tecentriq? 1% icpd-l1 expression in? 50% tc or? 10% ic determined by ventana pd-l1 (sp142) assay in non-small cell lung cancer (nsclc) patients may be associated with enhanced overall survival from tecentriq (atezolizumab). This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This product is intended for in vitro diagnostic (ivd) use.
| Device | VENTANA PD-L1(SP142) 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 | 2018-09-14 |
| Decision Date | 2019-03-08 |
| PMA | P160002 |
| Supplement | S009 |
| Product Code | PLS |
| Advisory Committee | Pathology |
| Supplement Type | Panel 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 |
| Summary: | Summary of Safety and Effectiveness |
| 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 |