Identity
- Trade Name
- MMR IHC Panel pharmDx (Dako Omnis) FDA PMA
- Generic Name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay FDA PMA
Identifiers
- PMA Number
- P250004 FDA PMA
- FDA Product Code
- QNH FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 864.1860 FDA PMA
- Regulation Number
- 864.1860 FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The MMR IHC Panel pharmDx (Dako Omnis) is a qualitative immunohistochemical (IHC) assay classified as an Immunohistochemistry Test, DNA Mismatch Repair (MMR) Protein Assay. It is designed to assess the presence of mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6) in formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue, aiding in the identification of MMR-deficient tumors.
This assay is intended for use on the Dako Omnis automated staining instrument with the EnVision FLEX visualization system. Supplied as a multi-component kit, it must be used in conjunction with MLH1, PMS2, MSH2, and MSH6 IHC pharmDx (Dako Omnis) reagents. The device is authorized under FDA_PMA (P250004) and falls under Class III regulatory classification (864.1860), with registration numbers 2028492, 2022180, 2916205, and 3009189893.
Frequently asked questions
What types of tissue samples is this device designed to analyze, and how does it work?
This device is specifically designed to analyze formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue samples. It functions as a qualitative immunohistochemical (IHC) assay to detect the presence of four mismatch repair (MMR) proteins—MLH1, PMS2, MSH2, and MSH6—by staining tissue sections. The results help identify whether a tumor is deficient in MMR proteins, which can guide treatment decisions, such as eligibility for immunotherapy with drugs like OPDIVO® or YERVOY®.
How is the MMR IHC Panel pharmDx (Dako Omnis) supplied, and what equipment is required to use it?
The MMR IHC Panel is supplied as a multi-component kit, including the individual reagents for MLH1, PMS2, MSH2, and MSH6 IHC assays. It must be used together with the Dako Omnis automated staining instrument and the EnVision FLEX visualization system. The kit is not standalone; all components and equipment are necessary for proper operation.
Is this device intended for single-use or can it be reused? How should it be stored?
The MMR IHC Panel pharmDx (Dako Omnis) is designed for single-use per the manufacturer’s specifications, as it is a multi-component kit of reagents intended for one assay cycle. Storage instructions are not explicitly detailed in the provided data, but typically, IHC reagents should be stored according to the manufacturer’s guidelines—often refrigerated or frozen until use, and protected from light and contamination.
What regulatory pathway was followed for this device, and what does that mean for its use?
This device was authorized under the FDA’s Premarket Approval (PMA) pathway, specifically PMA number P250004, and is classified as a Class III medical device (product code QNH). This means it underwent rigorous review to ensure safety and effectiveness for its intended use in identifying MMR-deficient colorectal cancer patients, particularly for guiding immunotherapy eligibility. The PMA designation indicates it has met stringent regulatory requirements before being approved for clinical use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P250004 | Class III | Active |
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Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
Sources (1)
- FDA PMA P250004 23 fields · synced Sep 18, 2026