510(k) DEN240067
DEN240067 is an FDA 510(k) premarket notification submitted by Cytocell Limited for the device "KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)". The FDA issued a decision of De Novo Granted on Sep 19, 2025. The device falls under product code SFS (Revumenib Eligibility Detection System), a Class II device regulated under 21 CFR 864.1885.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Sep 19, 2025
- Date Received
- Nov 22, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Revumenib Eligibility Detection System
- Device Class
- Class II
- Regulation Number
- 864.1885
- Review Panel
- PA
- Submission Type
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.