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.
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-small cell lung cancer (nsclc), squamous cell carcinoma of the head and neck (scchn), and urothelial carcinoma (uc) 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. Companion diagnostic indication tumor indication pd-l1 expression clinical cut off intended usensclc? 1% tumor cell expression pd-l1 ihc 28-8 pharmdx is indicated as an aid in identifying nsclc patients for treatment with opdivo® (nivolumab) in combination with yervoy® (ipilimumab). Pd-l1 expression (? 1% or? 5% or? 10% tumor cell expression), as detected by pd-l1 ihc 28-8 pharmdx in non-squamous nsclc may be associated with enhanced survival from opdivo®. Pd-l1 expression (? 1% tumor cell expression), as detected by pd-l1 ihc 28-8 pharmdx in scchn may be associated with enhanced survival from opdivo®. Pd-l1 expression (? 1% tumor cell expression), as detected by pd-l1 ihc 28-8 pharmdx in uc may be associated with enhanced response rate from opdivo®. See the opdivo® and yeryov® product labels for specific clinical circumstances guiding pd-l1 testing.
|Device||PD-L1 IHC 28-8 pharmDx|
|Generic Name||Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1|
|Applicant||DAKO NORTH AMERICA, INC.|
|Supplement Type||Panel Track|
|Supplement Reason||Labeling Change - Indications/instructions/shelf Life/tradename|
|Applicant Address||DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013|
|Supplement Number||Date||Supplement Type|
|S005||2016-12-29||Normal 180 Day Track No User Fee|