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| Device | VENTANA FOLR1 (FOLR-2.1) RxDx Assay |
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| Generic Name | Immunohistochemistry Assay, Antibody, FOLR1 |
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| Regulation Number | 864.1860 |
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| Applicant | Ventana Medical Systems Inc.
1910 E. Innovation Park Drive
Tucson, AZ 85755 |
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| PMA Number | P220006 |
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| Date Received | 04/25/2022 |
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| Decision Date | 11/14/2022 |
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| Product Code |
QUL |
| Docket Number | 22M-2869 |
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| Notice Date | 11/18/2022 |
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| Advisory Committee |
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| Clinical Trials | NCT04296890
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. The device is a qualitative immunohistochemical assay using mouse monoclonal anti-FOLR1, clone FOLR1-2.1, intended for use in the assessment of folate receptor alpha (FOLR1) protein in formalin-fixed, paraffin-embedded epithelial ovarian, fallopian tube or primary peritoneal cancer tissue specimens by light microscopy. This assay is for use with OptiView DAB IHC Detection Kit for staining on a BenchMark ULTRA instrument.FOLR1 expression clinical cut-off is >= 75% viable tumor cells (TC) with membrane staining at moderate and/or strong intensity levels.This assay is indicated as an aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer who may be eligible for treatment with ELAHERE (mirvetuximab soravtansine). Test results of the VENTANA FOLR1 (FOLR1-2.1) 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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