PMA P150013S001

Device

PD-L1 IHC 22C3 PHARMDX

Applicant

Agilent Technologies, Inc.

PMA number

P150013

Supplement

S001

Product code

PLS

Decision date

2016-10-24

Classification

Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1

Generic name

Immunohistochemistry assay, antibody, programmed death-ligand 1

Approval order statement

Approval for 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) 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 at any intensity. The specimen should be considered to have PD-L1 expression if TPS greater than or equal to 1% and high PD-L1 expression if TPS is greater than or equal to 50%. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab). See the KEYTRUDA® product label for expression cutoff values guiding therapy in specific clinical circumstances. This device is for in vitro diagnostic use.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf15/P150013S001B.pdf" target="_new">Summary of Safety and Effectiveness</a>