OncoMate® MSI Dx Analysis System
FDA premarket approval P240026 · decided 2025-11-05
Approval details
- PMA number
- P240026
- Trade name
- OncoMate® MSI Dx Analysis System
- Generic name
- Nucleic Acid Based Assay, Microsatellite Instability
- Applicant
- Promega Corporation
- Date received
- 2024-07-26
- Decision date
- 2025-11-05
- Days to decision
- 467 days
- Decision code
- APPR
- Product code
- SFL
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Madison, WI
- Statement
- Approval for the OncoMate® MSI Dx Analysis System. The OncoMate® MSI Dx Analysis System is a qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in five microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) for the identification of microsatellite instability (MSI) using DNA obtained from formalin-fixed, paraffin-embedded (FFPE) endometrial carcinoma tissue specimens, and DNA isolated from matched normal FFPE specimen or whole bl
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OncoMate MSI Dx Analysis System (K200129) | Promega Corporation | 2021-07-26 |