DEN240067 is an FDA 510(k) submission for the KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013). This device is classified as a Revumenib Eligibility Detection System (Class II - Special Controls, product code SFS).
Submitted by Cytocell Limited (Cambridge, GB). The FDA issued a Not Cleared (DENG) decision on September 19, 2025.
This device falls under the Medical Genetics FDA review panel. Regulated under 21 CFR 864.1885. A Revumenib Eligibility Detection System Is Identified As A Prescription In Vitro Diagnostic Device Intended For The Qualitative Detection Of Structural Abnormalities Of Chromosome 11 In Specimens From Patients With Acute Leukemia For The Purpose Of Identifying Patients Who May Benefit From Treatment With Revumenib, In Accordance With The Approved Therapeutic Product Labeling..
| 510(k) Number | DEN240067 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | November 22, 2024 |
| Decision Date | September 19, 2025 |
| Days to Decision | 301 days |
| Submission Type | Direct |
| Review Panel | Medical Genetics (MG) |
| Summary | - |
| Product Code | SFS - Revumenib Eligibility Detection System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.1885 |
| Definition | A Revumenib Eligibility Detection System Is Identified As A Prescription In Vitro Diagnostic Device Intended For The Qualitative Detection Of Structural Abnormalities Of Chromosome 11 In Specimens From Patients With Acute Leukemia For The Purpose Of Identifying Patients Who May Benefit From Treatment With Revumenib, In Accordance With The Approved Therapeutic Product Labeling. |