VENTANA MET (SP44) RxDx Assay
FDA premarket approval P240037 · decided 2025-05-14
Approval details
- PMA number
- P240037
- Trade name
- VENTANA MET (SP44) RxDx Assay
- Generic name
- Immunohistochemistry Assay, Antibody, MET
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- Date received
- 2024-10-21
- Decision date
- 2025-05-14
- Days to decision
- 205 days
- Decision code
- APPR
- Product code
- SER
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for the VENTANA MET (SP44) RxDx Assay. The device is a qualitative immunohistochemical assay using rabbit monoclonal anti-MET, clone SP44, intended for use in the assessment of MET protein in formalin-fixed, paraffin embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC) specimens by light microscopy. This assay is for use with OptiView DAB IHC Detection Kit for staining on a BenchMark ULTRA or BenchMark ULTRA PLUS instrument.MET protein expression clinical cut-off is >= 50% of
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