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 the device which will be marketed under the trade name pd-l1 ihc 28 - 8 pharmdx and is indicated for a qualitative immunohistochemical assay using monoclonal rabbit anti-pd-l1, clone 28-8 intended for use in the detection of pd-l1 protein in formalin-fixed, paraffin-embedded (ffpe) non-squamous non-small cell lung cancer (nsclc) and melanoma tissues using envision flex visualization system on autostainer link 48. Pd-l1 protein expression is defined as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity. Pd-l1 expression as detected by pd-l1 ihc 28-8 pharmdx in non-squamous nsclc may be associated with enhanced survival from opdivo® (nivolumab). Positive pd-l1 status as determined by pd-l1 ihc 28-8 pharmdx in melanoma is correlated with the magnitude of the treatment effect on progression-free survival from opdivo®.
| Device | PD-L1 IHC 28-8 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 | 2016-12-29 |
| Decision Date | 2017-05-03 |
| PMA | P150025 |
| Supplement | S005 |
| Product Code | PLS |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150025 | Original Filing | |
| S015 | 2022-06-17 | 30-day Notice |
| S014 | 2021-07-12 | Normal 180 Day Track |
| S013 | 2019-12-16 | Panel Track |
| S012 | ||
| S011 | 2019-02-15 | 30-day Notice |
| S010 | 2018-12-21 | 30-day Notice |
| S009 | 2018-03-12 | 30-day Notice |
| S008 | 2017-12-26 | 30-day Notice |
| S007 | ||
| S006 | 2017-04-17 | 30-day Notice |
| S005 | 2016-12-29 | Normal 180 Day Track No User Fee |
| S004 | 2016-12-27 | Real-time Process |
| S003 | 2016-12-22 | Panel Track |
| S002 | 2016-08-19 | Real-time Process |
| S001 | 2016-07-07 | Real-time Process |