# DEN240067: KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)

- Pathway: De Novo (Direct)
- Applicant: Cytocell Limited
- Decided: Sep 19, 2025 after 301 days
- Product code: SFS (Revumenib Eligibility Detection System)
- Device class: 2
- Regulation: 21 CFR 864.1885
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The CDA-LPH013 KMT2A Breakapart FISH Probe Kit PDx is a fluorescence in situ hybridization (FISH) test used to detect rearrangement of the KMT2A region on chromosome 11 at location 11q23.3 in 3:1 methanol/glacial acetic acid fixed bone marrow specimens from patients with acute leukemia with KMT2A rearrangement. The assay is indicated for detecting the presence of rearrangements involving the KMT2A region as a companion diagnostic to aid in identifying those patients for whom treatment with REVUFORJ® (revumenib) is indicated in accordance with the approved therapeutic product labeling. The CDA-LPH013 KMT2A Breakapart FISH Probe Kit PDx is not intended for monitoring of residual disease.

Source page: https://510kreport.com/device/DEN240067
Methodology: https://510kreport.com/methodology