Immunohistochemistry Assay, Antibody, Met
Basic Information
- Device Name
- Immunohistochemistry Assay, Antibody, Met
- Trade Name
- VENTANA MET (SP44) RxDx Assay
- PMA Number
- P240037
- Device Class
- FDA Class 3
- Product Code
- SER
- Generic Name
- Immunohistochemistry Assay, Antibody, MET
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 14, 2025
- Date Received
- October 21, 2024
- Expedited Review
- N
Advisory Committee 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 tumor cells exhibiting strong membrane and/or cytoplasmic staining (3+) in non-squamous NSCLC. VENTANA MET (SP44) RxDx Assay is indicated as an aid in identifying non-squamous NSCLC patients who may be eligible for treatment with EMRELIS (telisotuzumab vedotin-tllv). The results of VENTANA MET (SP44) RxDx Assay should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls.This product is intended for in vitro diagnostic (IVD) use.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SER | Immunohistochemistry Assay, Antibody, Met | FDA class 3 | Hematology |