SFL · Nucleic Acid Based Assay, Microsatellite Instability
· Class 3
Overview
| Product Code | SFL |
|---|---|
| Device Name | Nucleic Acid Based Assay, Microsatellite Instability |
| Device Class | Class 3 |
| Review Panel |
Identification
The microsatellite instability (MSI) companion diagnostic is nucleic acid based (molecular) in vitro diagnostic device intended for the qualitative detection of a panel of molecular biomarkers for identification of MSI in human clinical tissue specimens. It reports MSI status as either Microsatellite Stable (MSS) or Microsatellite Instability-High (MSI-H). The MSI companion diagnostic is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess MSI status which may be associated with a better clinical response to specific FDA approved therapeutic drugs.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P240026 | OncoMate® MSI Dx Analysis System | Promega Corporation | Nov 5, 2025 | APPR |
| P250005 | Idylla CDx MSI Test | Biocartis Us, Inc. | Aug 15, 2025 | APPR |
Top Applicants
- Biocartis Us, Inc. — 1 clearance
- Promega Corporation — 1 clearance
