DeviceClearance

Product code SFS— Hematology

KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)

Classification name
Revumenib Eligibility Detection System
Device class
Class 2
Regulation
21 CFR 864.1885
Advisory panel
Hematology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SFS under 21 CFR 864.1885, via openFDA

Market context for product code SFS

FDA has cleared 1 device under product code SFS, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SFS

Recent clearances under product code SFS

Data sourced from openFDA. This site is unofficial and independent of the FDA.