Identity
- Trade Name
- PD-L1 IHC 22C3 PHARMDX FDA PMA
- Generic Name
- Immunohistochemistry assay, antibody, programmed death-ligand 1 FDA PMA
Identifiers
- PMA Number
- P150013 FDA PMA
- FDA Product Code
- PLS FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemistry assay using a monoclonal mouse anti-PD-L1 antibody (clone 22C3). It is designed for detecting PD-L1 protein expression in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue samples. The assay quantifies PD-L1 expression via tumor proportion score (TPS), assessing the percentage of viable tumor cells with partial or complete membrane staining. Results aid in identifying NSCLC patients for treatment consideration with pembrolizumab (Keytruda).
This device is intended for use on the ENVISION FLEX Visualization System with the Autostainer Link 48. It is supplied as a single-use reagent kit and requires formal processing of FFPE tissue samples. The assay is approved by the FDA under a Premarket Approval (PMA) application (P150013) and is classified as a Class III medical device. Storage and handling must comply with manufacturer guidelines for immunohistochemistry reagents.
Frequently asked questions
What types of tissue samples is this assay designed to analyze, and how does it determine PD-L1 expression levels?
This assay is specifically designed for formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue samples. PD-L1 expression is quantified using the Tumor Proportion Score (TPS), which measures the percentage of viable tumor cells exhibiting partial or complete membrane staining. A sample is considered PD-L1 positive if 50% or more of viable tumor cells show membrane staining at any intensity.
Is this device single-use, and if so, what does that mean for workflow and cost management in a pathology lab?
Yes, the PD-L1 IHC 22C3 pharmDx is supplied as a single-use reagent kit. This means each kit is intended for one use only, requiring labs to plan for replacement kits per sample. While this ensures consistency and reduces cross-contamination risk, it may impact workflow efficiency and budgeting for high-volume labs, as each test requires a new kit.
What visualization system and automated platform is required to run this assay, and does it affect the assay’s performance?
The assay is designed exclusively for use on the ENVISION FLEX Visualization System paired with the Autostainer Link 48 automated platform. These systems are optimized for the assay’s workflow, ensuring accurate detection of PD-L1 protein expression via the Tumor Proportion Score (TPS). Performance is dependent on proper integration with these systems, as they handle staining, visualization, and image analysis.
How should this assay be stored, and are there any special handling requirements for maintaining its integrity?
Storage and handling must strictly follow the manufacturer’s guidelines for immunohistochemistry reagents, though specific conditions (e.g., temperature, light exposure) are not detailed in the provided data. Since it is a single-use kit, proper storage ensures the assay remains effective until use. Failure to adhere to guidelines could compromise the assay’s performance or validity of results.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P150013 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
Sources (1)
- FDA PMA P150013 24 fields · synced Sep 18, 2026