510(k) DEN240067

KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) by Cytocell Limited — Product Code SFS

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: September 19, 2025
Date Received: November 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.