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OncoMate MSI Dx Analysis System

FDA PMAEUDAMEDFDA 510(k)

Class III (US FDA PMA)

PMA P240026510(k) K200129Ref MD3140

by Promega Corporation

Identity

Trade Name
OncoMate® MSI Dx Analysis System EUDAMEDFDA PMA
Generic Name
Nucleic Acid Based Assay, Microsatellite Instability FDA PMA
Device Name
OncoMate® MSI Dx Analysis System EUDAMED
Model / Reference
MD3140 EUDAMED

Identifiers

Primary DI / UDI-DI
00849811057120 EUDAMED
Basic UDI-DI
B-00849811057120 EUDAMED
PMA Number
P240026 FDA PMA
510(k) Number
K200129 FDA PMA
FDA Product Code
PZJ FDA PMA
EMDN Code
W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Class II FDA PMA
Legislation / Framework
21 CFR Part 864.1866 FDA PMA
Regulation Number
864.1866 FDA PMA
Market of Registration
Germany EUDAMED
Advisory Committee
Immunology FDA PMA
FDA Decision
SESE Substantially Equivalent FDA PMA

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

The OncoMate MSI Dx Analysis System is a qualitative multiplex polymerase chain reaction test designed to detect mononucleotide deletions in five specific microsatellite loci. It identifies microsatellite instability using DNA extracted from formalin-fixed, paraffin-embedded endometrial carcinoma tissue and matched normal specimens or whole blood.

This system is intended for use with the Applied Biosystems 3500 Dx Genetic Analyzer and the OncoMate MSI Dx Analysis Software. It serves as a companion diagnostic to identify patients with microsatellite stable endometrial carcinoma who may be candidates for treatment with pembrolizumab in combination with lenvatinib. The device is authorized under FDA 510K, FDA PMA, and IVDD regulatory pathways.

Frequently asked questions

What is the primary purpose of the OncoMate MSI Dx Analysis System?

The system is a qualitative multiplex PCR test used to detect microsatellite instability by identifying deletions in five specific microsatellite loci, including BAT-25, BAT-26, NR-21, NR-24, and MONO-27.

What type of specimens are required for this test?

The test requires DNA obtained from formalin-fixed, paraffin-embedded (FFPE) endometrial carcinoma tissue specimens, as well as DNA isolated from matched normal FFPE specimens or whole blood.

How is this system used in clinical treatment?

It acts as a companion diagnostic to identify patients with microsatellite stable endometrial carcinoma who may benefit from combination therapy with KEYTRUDA (pembrolizumab) and LENVIMA (lenvatinib).

What equipment is required to run the OncoMate MSI Dx Analysis System?

The system is designed for use specifically with the Applied Biosystems 3500 Dx Genetic Analyzer and the dedicated OncoMate MSI Dx Analysis Software.

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. Sources consulted: FDA Approves Promega OncoMate® MSI Dx Analysis System as ..., FDA Clears Promega OncoMate® MSI Dx Analysis System, Premarket Approval (PMA) - FDA, OncoMate® MSI Dx Analysis System | CE-Marked IVD, OncoMate® MSI Dx Analysis Software - Promega Corporation

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Promega Corporation

Sources (3)

  • FDA PMA P240026 37 fields · synced Sep 18, 2026
  • EUDAMED fa7b6bfc-ab33-4b55-9cc7-938cd762d857 61 fields · synced Jul 30, 2026
  • FDA 510(k) K200129 1 fields · synced May 18, 2026