Identity
- Trade Name
- VENTANA PD-L1 (SP142) Assay FDA PMA
- Generic Name
- Immunohistochemistry assay, antibody, programmed death-ligand 1 FDA PMA
Identifiers
- PMA Number
- P160006 FDA PMA
- FDA Product Code
- PLS FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APCB FDA PMA
The Ventana PD-L1 (SP142) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP142. It is classified as an Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 and is designed for detecting PD-L1 protein expression in formalin-fixed, paraffin-embedded (FFPE) tissue samples from urothelial carcinoma and non-small cell lung cancer (NSCLC). The assay evaluates PD-L1 status based on either the proportion of tumor-infiltrating immune cells (% IC) or tumor cells (% TC) expressing PD-L1.
This assay is performed using the OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a Ventana BenchMark ULTRA instrument. It is intended for laboratory use and is supplied as a single-use diagnostic tool. The device is authorized under FDA_PMA (PMA Number: P160006) and is categorized under device class 3. No specific sterility or MRI safety information is provided in the data, but it is regulated as a high-risk medical device requiring strict adherence to clinical validation protocols.
Frequently asked questions
What types of tissue samples is the VENTANA PD-L1 (SP142) Assay designed to analyze, and how is the PD-L1 status determined within those samples?
The VENTANA PD-L1 (SP142) Assay is specifically designed for formalin-fixed, paraffin-embedded (FFPE) tissue samples from urothelial carcinoma and non-small cell lung cancer (NSCLC). PD-L1 status is determined by evaluating either the proportion of tumor-infiltrating immune cells (% IC) expressing PD-L1 or the percentage of PD-L1 expressing tumor cells (% TC), regardless of staining intensity. This helps assess potential patient responses to therapies like atezolizumab (TECENTRIQ).
How is the VENTANA PD-L1 (SP142) Assay performed in a clinical laboratory, and what equipment is required?
The assay is performed using the OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a Ventana BenchMark ULTRA instrument. It involves immunohistochemical staining of FFPE tissue samples with a rabbit monoclonal anti-PD-L1 antibody (clone SP142) to detect PD-L1 protein expression. The BenchMark ULTRA is a dedicated automated platform for this process.
Is the VENTANA PD-L1 (SP142) Assay intended for single-use or repeated use, and what regulatory pathway was followed for its approval?
The VENTANA PD-L1 (SP142) Assay is supplied as a single-use diagnostic tool, meaning each assay kit is intended for one use only. It was authorized through the FDA’s **PMA (Premarket Approval)** pathway, classified as a **Class 3 device**, reflecting its high-risk nature and the need for strict clinical validation before approval.
What clinical significance does PD-L1 expression have for patients with urothelial carcinoma or NSCLC when using this assay?
In urothelial carcinoma, PD-L1 expression in ≥5% of tumor-infiltrating immune cells (% IC) detected by this assay was associated with an increased objective response rate to atezolizumab (TECENTRIQ) in a non-randomized study. For NSCLC, PD-L1 expression in ≥50% of tumor cells (% TC) or ≥10% of immune cells (% IC) may correlate with improved overall survival when treated with atezolizumab, though these associations are not guarantees of individual patient outcomes.
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 | P160006 | Class III | Active |
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Manufacturer
- Manufacturer
- Ventana Medical Systems, Inc.
Sources (1)
- FDA PMA P160006 24 fields · synced Oct 6, 2026