PD-L1 IHC 28-8 PHARMDX
by Dako North America, Inc. PMA
Active
PMA P150027
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPCB | NumberP150027 | Date23 Jan 2016 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- PD-L1 IHC 28-8 PHARMDX (Melanoma Indication)
- Trade Name
- PD-L1 IHC 28-8 pharmDx
- Generic Name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- PMA Number
- FDA Product Code
- PLS
- Device Class
- Class III
- Advisory Committee
- Pathology
- FDA Decision
- APCB
Overview
AI-generated summary, 18 Sep 2026
PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemistry assay using monoclonal rabbit anti-PD-L1, clone 28-8, intended for the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC) and melanoma tissue. It utilizes the EnVision FLEX visualization system on the Autostainer Link 48 platform to assess PD-L1 protein expression as the percentage of tumor cells exhibiting positive membrane staining at any intensity.
The device is supplied as a diagnostic reagent kit for use in clinical pathology laboratories. It is intended for in vitro diagnostic use and is regulated under FDA PMA (P150027) as a Class III device. PD-L1 expression detected by this assay in melanoma is correlated with the magnitude of treatment effect on progression-free survival from OPDIVO® (nivolumab).
Other devices from Dako North America, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of tissue is the PD-L1 IHC 28-8 pharmDx assay designed to test?
The PD-L1 IHC 28-8 pharmDx assay is designed for use on formalin-fixed, paraffin-embedded (FFPE) tissue from non-squamous non-small cell lung cancer (NSCLC) and melanoma specimens, as specified in the device's indications for use.
How is PD-L1 protein expression measured by this assay?
PD-L1 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity, as determined by immunohistochemical staining using the EnVision FLEX visualization system on the Autostainer Link 48 platform.
What is the clinical relevance of a positive PD-L1 result in melanoma patients tested with this assay?
Positive PD-L1 status as determined by the PD-L1 IHC 28-8 pharmDx assay in melanoma tissue is correlated with the magnitude of the treatment effect on progression-free survival from OPDIVO® (nivolumab), indicating its role as a biomarker for predicting response to this therapy.