Not Cleared Direct

DEN170070 - MLL (KMT2A) Breakapart FISH Probe Kit (FDA 510(k) Clearance)

Also includes:
AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit Del(7q)Deletion FISH Probe Kit

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

DEN170070 · Cytocell, Ltd. · Medical Genetics device
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Dec 2018
Decision
448d
Days
Class 2
Risk

DEN170070 is an FDA 510(k) submission (not cleared) for the MLL (KMT2A) Breakapart FISH Probe Kit. Classified as Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies (product code QDI), Class II - Special Controls.

Submitted by Cytocell, Ltd. (Cambridge, GB). The FDA issued a Not Cleared (DENG) decision on December 21, 2018 after a review of 448 days.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 864.1880 - 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 448 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.

View all Cytocell, Ltd. devices

Submission Details

510(k) Number DEN170070 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 29, 2017
Decision Date December 21, 2018
Days to Decision 448 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
49d slower than avg
Panel avg: 399d · This submission: 448d
Pathway characteristics

Device Classification

Product Code QDI Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1880
Definition Fluorescence In Situ Hybridization (fish) Test For Hematologic Malignancies Is Used To Detect Chromosomal Abnormalities In Human Specimens From Patients With Hematologic Malignancies. The Test Is Indicated For The Clinical Management Of Patients Consistent With World Health Organization (who) Guidelines And In Conjunction With Other Clinical And Diagnostic Criteria. The Results Are To Be Interpreted By A Pathologist Or Equivalent Professional.
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.