Immunohistochemistry Assay, Antibody, Folr1
Basic Information
- Device Name
- Immunohistochemistry Assay, Antibody, Folr1
- Trade Name
- VENTANA FOLR1 (FOLR-2.1) RxDx Assay
- PMA Number
- P220006
- Device Class
- FDA Class 3
- Product Code
- QUL
- Generic Name
- Immunohistochemistry Assay, Antibody, FOLR1
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Advisory Committee
- Medical Genetics
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 14, 2022
- Date Received
- April 25, 2022
- Expedited Review
- N
- Docket Number
- 22M-2869
Advisory Committee 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.
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 |
|---|---|---|---|
| QUL | Immunohistochemistry Assay, Antibody, Folr1 | FDA class 3 | Hematology |