PLS · Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
· Class 3
Overview
| Product Code | PLS |
|---|---|
| Device Name | Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 |
| Device Class | Class 3 |
| Review Panel |
Identification
The programmed death-ligand 1 (PD-L1) antibody is a qualitative immunohistochemical antibody intended to identify PD-L1 protein expression in human clinical tissue specimens. The PD-L1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess PD-L1 expression level in patients who may respond particularly well to specific FDA approved therapeutic drugs.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P160046 | VENTANA PD-L1 (SP263) ASSAY | Ventana Medical Systems, Inc. | May 1, 2017 | APPR |
| P160006 | VENTANA PD-L1 (SP142) Assay | Ventana Medical Systems, Inc. | Oct 18, 2016 | APCB |
| P160002 | VENTANA PD-L1(SP142) CDX ASSAY | Ventana Medical Systems, Inc. | May 18, 2016 | APPR |
| P150027 | PD-L1 IHC 28-8 pharmDx | Dako North America, Inc. | Jan 23, 2016 | APCB |
| P150013 | PD-L1 IHC 22C3 PHARMDX | Agilent Technologies, Inc. | Oct 2, 2015 | APPR |
Top Applicants
- Ventana Medical Systems, Inc. — 3 clearances
- Agilent Technologies, Inc. — 1 clearance
- Dako North America, Inc. — 1 clearance
