Approval for pd-l1 ihc 22c3 pharmdx is a qualitative immunohistochemical assay using monoclonal mouse anti-pd-l1, clone 22c3 intended for use in the detection of pd-l1 protein in formalin-fixed, paraffin-embedded (ffpe) non-small cell lung cancer (nsclc) tissue using envision flex visualization system on autostainer link 48. Pd-l1 protein expression is determined by using tumor proportion score (tps), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen should be considered to have pd-l1 expression if tps greater than or equal to 1% and high pd-l1 expression if tps is greater than or equal to 50%. Pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying nsclc patients for treatment with keytruda® (pembrolizumab). See the keytruda® product label for expression cutoff values guiding therapy in specific clinical circumstances. This device is for in vitro diagnostic use.
| Device | PD-L1 IHC 22C3 PHARMDX |
| Classification Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Generic Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Applicant | DAKO NORTH AMERICA, INC. |
| Date Received | 2015-12-31 |
| Decision Date | 2016-10-24 |
| Notice Date | 2016-11-28 |
| PMA | P150013 |
| Supplement | S001 |
| Product Code | PLS |
| Docket Number | 16M-3913 |
| Advisory Committee | Pathology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150013 | | Original Filing |
| S025 |
2022-08-08 |
Real-time Process |
| S024 |
2022-01-31 |
Special (immediate Track) |
| S023 |
2021-11-17 |
Special (immediate Track) |
| S022 | | |
| S021 |
2020-08-31 |
Normal 180 Day Track |
| S020 |
2020-06-29 |
Panel Track |
| S019 |
2020-02-06 |
Normal 180 Day Track No User Fee |
| S018 |
2019-09-05 |
Normal 180 Day Track No User Fee |
| S017 |
2019-06-14 |
Normal 180 Day Track |
| S016 |
2019-02-25 |
Panel Track |
| S015 |
2019-02-15 |
30-day Notice |
| S014 | | |
| S013 |
2018-12-21 |
30-day Notice |
| S012 | | |
| S011 |
2018-06-25 |
Panel Track |
| S010 |
2018-03-12 |
30-day Notice |
| S009 |
2018-01-29 |
Panel Track |
| S008 |
2017-12-26 |
30-day Notice |
| S007 |
2017-09-21 |
Normal 180 Day Track No User Fee |
| S006 |
2017-04-19 |
Panel Track |
| S005 |
2017-04-17 |
30-day Notice |
| S004 |
2016-12-27 |
Real-time Process |
| S003 |
2016-08-19 |
Real-time Process |
| S002 |
2016-06-28 |
Real-time Process |
| S001 |
2015-12-31 |
Panel Track |
NIH GUDID Devices