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| Device | VENTANA CLDN18 (43-14A) RxDx Assay |
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| Generic Name | Immunohistochemistry assay, antibody, claudin 18 |
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| Regulation Number | 864.1860 |
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| Applicant | Ventana Medical Systems Inc.
1910 East Innovation Park Drive
Tucson, AZ 85755 |
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| PMA Number | P230018 |
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| Date Received | 06/09/2023 |
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| Decision Date | 10/18/2024 |
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| Product Code |
QZJ |
| Advisory Committee |
Pathology |
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| Clinical Trials | NCT03504397
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order 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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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