Approval for the pd-l1 ihc 22c3 pharmdx. This device is indicated for the following: pd-l1 ihc 22c3 pharmdx is a qualitative immunohistochemical assay using monoclonal mouse anti-pd-l1, clone 22c3 antibody intended for use in the detection of pd-l1protein 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. The specimen should be considered pd-l1 positive if tps >= 50% of the viable tumor cells exhibit membrane staining at any intensity. Pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying nsclc patients for treatment with keytruda (pembrolizumab).
| 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 | 2015-04-06 |
| Decision Date | 2015-10-02 |
| Notice Date | 2015-11-02 |
| PMA | P150013 |
| Supplement | S |
| Product Code | PLS |
| Docket Number | 15M-3520 |
| Advisory Committee | Pathology |
| 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