Approval for labeling changes to include results from additional non-clinical studies that were conducted as specified in the june 12, 2018 approval letter for p150013/s009. The device will be marketed under the trade name pd-l1 ihc 22c3 pharmdx and is indicated for the following: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), gastric or gastroesophageal junction (gej) adenocarcinoma, esophageal squamous cell carcinoma (escc), cervical cancer, urothelial carcinoma and head and neck squamous cell carcinoma (hnscc) tissues using envision flex visualization system on autostainer link 48. Pd-l1 protein expression in nsclc 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. Pd-l1 protein expression in gastric or gej adenocarcinoma, escc, cervical cancer, urothelial carcinoma and hnscc is determined by using combined positive score (cps), which is the number of pd-l1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. Tumor indication pd-l1 expression level intended usensclc tps? 1% pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying nsclc patients for treatment with keytruda® (pembrolizumab). **gastric or gej adenocarcinoma cps? 1 pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying gastric or gej adenocarcinoma patients for treatment with keytruda® (pembrolizumab). Escc cps? 10 pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying escc patients for treatment with keytruda® (pembrolizumab). Cervical cancer cps? 1 pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying cervical cancer patients for treatment with keytruda® (pembrolizumab). Urothelial carcinoma cps? 10 pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying urothelial carcinoma patients for treatment with keytruda® (pembrolizumab). **hnscc cps? 1 pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying hnscc patients for treatment with keytruda® (pembrolizumab). **for in vitro diagnostic use. 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), gastric or gastroesophageal junction (gej) adenocarcinoma, esophageal squamous cell carcinoma (escc), cervical cancer, urothelial carcinoma and head and neck squamous cell carcinoma (hnscc) tissues using envision flex visualization system on autostainer link 48. Pd-l1 protein expression in nsclc 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. Pd-l1 protein expression in gastric or gej adenocarcinoma, escc, cervical cancer, urothelial carcinoma and hnscc is determined by using combined positive score (cps), which is the number of pd-l1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
| Device | PD-L1 IHC 22C3 PharmDx |
| Generic Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Applicant | DAKO NORTH AMERICA, INC. |
| Date Received | 2019-09-05 |
| Decision Date | 2020-02-27 |
| PMA | P150013 |
| Supplement | S018 |
| Product Code | PLS |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013 |
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