VENTANA FOLR1 (FOLR-2.1) RxDx Assay

FDA Premarket Approval P220006

Pre-market Approval Supplement Details

• Device: VENTANA FOLR1 (FOLR-2.1) RxDx Assay
• Generic Name: Immunohistochemistry Assay, Antibody, Folr1
• Applicant: Ventana Medical Systems Inc.1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP220006 Date Received04/25/2022 Decision Date11/14/2022 Product Code QUL Advisory Committee Clinical TrialsNCT04296890 Expedited Review Granted? No
• Date Received: 2022-04-25
• Decision Date: 2022-11-14
• PMA: P220006
• Supplement: S
• Product Code: QUL
• Expedited Review: No
• Combination Product: No
• Applicant Address: Ventana Medical Systems Inc.; 1910 E. Innovation Park Drive; tucson, AZ 85755 PMA NumberP220006 Date Received04/25/2022 Decision Date11/14/2022 Product Code QUL Advisory Committee Clinical TrialsNCT04296890; Expedited Review Granted? No Combination ProductNo Approval Order Statement ; VENTANA FOLR1 (FOLR1-2.1) RxDx Assay 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 OrderApproval Order SummarySummary Of Safety And Effectiveness LabelingLabeling; Supplements:

Supplemental Filings

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Supplement Number	Date	Supplement Type
P220006		Original Filing

NIH GUDID Devices

Device ID	PMA	Supp
07613336188019	P220006	000
07613336103241	P220006	000