Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
Basic Information
- Device Name
- Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
- Trade Name
- MMR IHC Panel pharmDx (Dako Omnis)
- PMA Number
- P250004
- Device Class
- FDA Class 3
- Product Code
- QNH
- Generic Name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 15, 2025
- Date Received
- February 18, 2025
- Expedited Review
- N
Advisory Committee Statement
For In Vitro Diagnostic Use.MMR IHC Panel pharmDx (Dako Omnis) is a qualitative immunohistochemical (IHC) assay intended for use in the assessment of mismatch repair (MMR) proteins (MLH1, PMS2, MSH2, and MSH6) in formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue using EnVision FLEX visualization system on Dako Omnis automated staining instrument. MMR IHC Panel pharmDx (Dako Omnis) consists of MLH1 IHC pharmDx (Dako Omnis), PMS2 IHC pharmDx (Dako Omnis), MSH2 IHC pharmDx (Dako Omnis), and MSH6 IHC pharmDx (Dako Omnis), which must be used together to identify MMR deficient CRC patients.MMR IHC Panel pharmDx (Dako Omnis) is indicated as an aid to identify MMR deficient CRC patients eligible for treatment with OPDIVO® (nivolumab) alone or OPDIVO (nivolumab) in combination with YERVOY® (ipilimumab).
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 |
|---|---|---|---|
| QNH | Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay | FDA class 3 | Hematology |