Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
Basic Information
- Device Name
- Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
- Trade Name
- PD-L1 IHC 22C3 PHARMDX
- PMA Number
- P150013
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- PLS
- Generic Name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 24, 2016
- Date Received
- December 31, 2015
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- Y
- Docket Number
- 16M-3913
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PLS | Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 | FDA class 3 | Unknown |