Identity
- Trade Name
- PD-L1 IHC 28-8 pharmDx FDA PMA
Identifiers
- PMA Number
- P150025 FDA PMA
Classification
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using a monoclonal rabbit anti-PD-L1 antibody (clone 28-8). It is designed for detecting PD-L1 protein expression in formalin-fixed, paraffin-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC) tissue samples. The assay provides a means to assess tumor cell membrane staining intensity and percentage, aiding in the evaluation of PD-L1 expression levels as a potential biomarker for treatment consideration.
This device is intended for use with the ENVISION FLEX Visualization System on the Autostainer Link 48. Supplied as a kit, it includes reagents for 50 tests (50 slides for primary antibody incubation and 50 slides for negative control) along with 15 control slides. The assay is approved for use in pathology settings and is classified under the FDA’s PMA (Premarket Approval) framework, with PMA number P150025. It is not intended for MRI use and is supplied as a single-use diagnostic reagent.
Frequently asked questions
What types of tissue samples is this assay designed to analyze, and why is this specific limitation important?
This assay is specifically designed for formalin-fixed, paraffin-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC) tissue samples. The limitation to NSCLC is important because PD-L1 expression patterns and clinical relevance can vary significantly between different cancer types. Using this assay on other tissue types could lead to inaccurate results and potentially misleading treatment decisions.
How is the PD-L1 IHC 28-8 pharmDx kit supplied, and what does the kit include for testing?
The kit is supplied as a single-use diagnostic reagent and includes reagents for 50 tests, which means it provides 50 slides for primary antibody incubation and 50 slides for negative control. Additionally, it includes 15 control slides to ensure assay accuracy and reliability during testing. This setup allows for comprehensive evaluation of PD-L1 expression in NSCLC samples.
What visualization system and automated platform is required to perform this assay, and why is this combination necessary?
The assay requires use with the ENVISION FLEX Visualization System on the Autostainer Link 48 platform. This combination is necessary because the ENVISION FLEX system is optimized for the specific monoclonal rabbit anti-PD-L1 antibody (clone 28-8) used in this assay, ensuring consistent and accurate detection of PD-L1 protein expression. The Autostainer Link 48 automates the staining process, improving reproducibility and efficiency in pathology labs.
How is PD-L1 expression defined by this assay, and what clinical relevance does it hold?
PD-L1 expression is defined by this assay as the percentage of tumor cells exhibiting positive membrane staining at any intensity. Clinically, PD-L1 expression detected by the PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival when treated with OPDIVO (nivolumab), a PD-1 immune checkpoint inhibitor. This helps guide treatment decisions for patients with NSCLC.
Is this assay reusable, and if not, why is it supplied as a single-use diagnostic reagent?
No, this assay is not reusable and is supplied as a single-use diagnostic reagent. This is because immunohistochemical assays like this one rely on precise, uncontaminated reagents to ensure accurate and reliable detection of PD-L1 protein expression. Reuse could introduce cross-contamination or degradation of reagents, compromising the integrity of the results and potentially affecting patient care decisions.
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. Sources consulted: PD-L1 IHC 28-8 pharmDx | Agilent, PD-L1 IHC 28-8 pharmDx Overview - Agilent, Agilent Receives FDA Approval for PD-L1 IHC 28-8 pharmDx in Esophageal ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P150025 | N/A | Active |
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Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
Sources (1)
- FDA PMA P150025 24 fields · synced Sep 18, 2026