Immunohistochemistry Assay, Antibody, Claudin 18
Basic Information
- Device Name
- Immunohistochemistry Assay, Antibody, Claudin 18
- Trade Name
- VENTANA CLDN18 (43-14A) RxDx Assay
- PMA Number
- P230018
- Device Class
- FDA Class 3
- Product Code
- QZJ
- Generic Name
- Immunohistochemistry assay, antibody, claudin 18
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 18, 2024
- Date Received
- June 9, 2023
- Expedited Review
- N
Advisory Committee Statement
VENTANA CLDN18 (43-14A) RxDx Assay is a qualitative immunohistochemical assay using mouse monoclonal anti-claudin 18, clone (43-14A), intended for laboratory use in the assessment of claudin 18 (CLDN18) protein in formalin-fixed, paraffin-embedded (FFPE) gastric adenocarcinoma including gastroesophageal junction (GEJ) tissue specimens by light microscopy. This assay is used with OptiView DAB IHC Detection Kit for staining on a BenchMark ULTRA instrument.The assay is indicated as an aid in identifying patients with gastric or GEJ adenocarcinoma who may be eligible for treatment with VYLOY (zolbetuximab) in accordance with the approved therapeutic product labeling. The clinical cutoff for the therapeutic product is ? 75% viable tumor cells (% TC) demonstrating moderate to strong membrane CLDN18 staining above background. Test results of the VENTANA CLDN18 (43-14A) 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 |
|---|---|---|---|
| QZJ | Immunohistochemistry Assay, Antibody, Claudin 18 | FDA class 3 | Hematology |