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 pd-l1 ihc 28-8 pharmdx for expanding the indications to squamous cell carcinoma of the head and neck, and urothelial cancer patients. This device is indicated for the following:for in vitro diagnostic use. Pd-l1 ihc 28-8 pharmdx is 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), squamous cell carcinoma of the head and neck (scchn), urothelial carcinoma (uc), 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. Tumor pd-l1 status is defined by indication specific staining interpretation. Tumor indication* intended use pd-l1 expression clinical cut off nsnsclc pd-l1 expression as detected by pd-l1 ihc 28-8 pharmdx in non-squamous nsclc and scchn may be associated with enhanced survival from opdivo® (nivolumab). >=1%, >=5%, >=10% scchn >=1% uc pd-l1 expression as detected by pd-l1 ihc 28-8 pharmdx in uc may be associated with enhanced response rate from opdivo®. >=1% melanoma 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®. >=1% *for details on staining interpretation, refer to section 13 of the product insert and indication specific pd-l1 ihc 28-8 pharmdx interpretation manuals.
| 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 | 2016-12-22 |
| Decision Date | 2017-09-15 |
| Notice Date | 2017-09-29 |
| PMA | P150025 |
| Supplement | S003 |
| Product Code | PLS |
| Docket Number | 17M-5813 |
| Advisory Committee | Pathology |
| Supplement Type | Panel Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| 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 |
| 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 |