Identity
- Trade Name
- VENTANA PD-L1 (SP263) ASSAY FDA PMA
- Generic Name
- Immunohistochemistry assay, antibody, programmed death-ligand 1 FDA PMA
Identifiers
- PMA Number
- P160046 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 VENTANA PD-L1 (SP263) Assay is a qualitative immunohistochemical assay using a rabbit monoclonal anti-PD-L1 antibody (clone SP263). It is designed to detect the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) urothelial carcinoma tissue samples, enabling assessment of PD-L1 expression levels for diagnostic purposes.
This assay is performed using the OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument. PD-L1 status is determined by evaluating tumor cell membrane staining or immune cell staining intensity, with criteria defining High status as either ≥25% tumor cell membrane staining, or specific thresholds of immune cell presence and positivity. The device received FDA_PMA authorization under PMA number P160046, classified as a Class III medical device.
Frequently asked questions
What types of tissue samples is the VENTANA PD-L1 (SP263) Assay designed to analyze, and how are they prepared before testing?
The VENTANA PD-L1 (SP263) Assay is specifically designed to detect PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) urothelial carcinoma tissue samples. Before testing, these samples must be prepared by fixing them in formalin and embedding them in paraffin, following standard histopathological procedures.
How is PD-L1 status determined using this assay, and what criteria define a 'High' status?
PD-L1 status is determined by evaluating tumor cell membrane staining or immune cell staining intensity. A 'High' status is defined by three criteria: (1) ≥25% of tumor cells showing membrane staining, (2) immune cells present (>1%) with ≥25% PD-L1 positive staining, or (3) exactly 1% immune cells present with 100% PD-L1 positive staining. This classification helps assess potential response to treatments like IMFINZI (durvalumab).
What equipment and reagents are required to perform the VENTANA PD-L1 (SP263) Assay?
The assay requires the VENTANA BenchMark ULTRA instrument for processing and the OptiView DAB IHC Detection Kit for visualization. The assay itself uses a rabbit monoclonal anti-PD-L1 antibody (clone SP263) to detect PD-L1 expression in FFPE urothelial carcinoma samples. These components work together to enable qualitative immunohistochemical analysis.
Is the VENTANA PD-L1 (SP263) Assay intended for single-use or reusable applications, and how should it be stored?
The assay is designed for single-use per tissue sample, as it involves specific reagents and a dedicated workflow on the BenchMark ULTRA instrument. Storage conditions are not explicitly detailed in the data, but reagents like the OptiView DAB IHC Detection Kit and antibody-based assays typically require refrigeration (2–8°C) and protection from light until use, following manufacturer guidelines.
What clinical context or specialty is this assay primarily associated with, and how does it support treatment decisions?
The assay falls under the pathology specialty and is classified for use in assessing PD-L1 expression in urothelial carcinoma, which is critical for guiding immunotherapy decisions. While not explicitly stating an indication, its association with increased objective response rates to IMFINZI (durvalumab) in clinical studies suggests it aids oncologists in selecting patients who may benefit from PD-1/PD-L1 inhibitors.
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: Home | Ventana
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P160046 | N/A | Active |
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Manufacturer
- Manufacturer
- Ventana Medical Systems, Inc.
Sources (1)
- FDA PMA P160046 24 fields · synced Oct 6, 2026