Not Cleared Direct

DEN240067 - KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) (FDA 510(k) Clearance)

Class II Medical Genetics device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN240067 · Cytocell Limited · Medical Genetics device
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Sep 2025
Decision
301d
Days
Class 2
Risk

DEN240067 is an FDA 510(k) submission (not cleared) for the KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013). Classified as Revumenib Eligibility Detection System (product code SFS), Class II - Special Controls.

Submitted by Cytocell Limited (Cambridge, GB). The FDA issued a Not Cleared (DENG) decision on September 19, 2025 after a review of 301 days.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 864.1885 - the FDA medical genetics device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 301 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 399d · This submission: 301d
Pathway characteristics

Device Classification

Product Code SFS Revumenib Eligibility Detection System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Medical Genetics devices follow this clearance model.