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MLL (KMT2A) Breakapart FISH Probe Kit +4 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) DEN170070

by Cytocell, Ltd.

Identifiers

510(k) Number
DEN170070 FDA 510(k)
FDA Product Code
QDI FDA 510(k)
Models / Variants
MLL (KMT2A) Breakapart FISH Probe Kit FDA 510(k)EUDAMED
AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit FDA 510(k)EUDAMED
EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit FDA 510(k)EUDAMED
AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit, Del(5q)Deletion FISH Probe Kit FDA 510(k)EUDAMED
Del(7q)Deletion FISH Probe Kit FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.1880 FDA 510(k)
Regulation Number
864.1880 FDA 510(k)
Advisory Committee
Medical Genetics FDA 510(k)
FDA Decision
DENG FDA 510(k)

This kit comprises Fluorescence In Situ Hybridisation (FISH) probes designed for detecting specific chromosomal abnormalities associated with hematologic malignancies. It includes breakapart and deletion probes for genes such as MLL (KMT2A), AML1 (RUNX1), P53 (TP53), EVI1 (MECOM), and Del(20q), as well as dual fusion probes for AML1/ETO (RUNX1/RUNX1T1) and CBFB/MYH11 translocations. The probes facilitate genetic analysis to identify genetic rearrangements linked to conditions like acute myeloid leukemia (AML) and other blood disorders.

The kit is intended for use in clinical laboratories under in vitro diagnostic regulations (IVDR) and has received FDA 510(k) clearance. Supplied as a reagent kit, it requires preparation in a controlled laboratory setting and is designed for single-use per manufacturer specifications. Compliance with regulatory standards ensures accurate detection of targeted genetic alterations for diagnostic purposes, supporting informed clinical decision-making in medical genetics.

Frequently asked questions

What types of genetic abnormalities can this kit detect, and how might they relate to patient care?

This kit detects specific chromosomal abnormalities linked to hematologic malignancies, including gene breakapart patterns (like MLL/KMT2A or AML1/RUNX1), deletions (such as P53/TP53, Del(20q), Del(5q), or Del(7q)), and dual fusion translocations (e.g., AML1/ETO or CBFB/MYH11). These genetic markers are associated with conditions like acute myeloid leukemia (AML) and other blood disorders, helping clinicians identify high-risk patients, refine diagnoses, and tailor treatment plans based on molecular profiling.

Is this kit designed for single-use, and if so, what does that mean for my lab’s workflow?

Yes, the kit is explicitly designed for single-use per manufacturer specifications. This means each kit is intended for one diagnostic procedure, ensuring sterility and accuracy without carryover risks. Your lab will need to prepare a new kit for each patient sample, which may require planning for reagent inventory and workflow adjustments to accommodate this usage model.

How is this kit regulated, and what does that mean for my lab’s compliance?

The kit is authorized under both FDA 510(k) clearance and the In Vitro Diagnostic Regulation (IVDR), meaning it meets stringent standards for accuracy, reliability, and safety in clinical diagnostics. Your lab must ensure compliance with IVDR requirements (e.g., risk management, traceability, and quality systems) since it’s intended for use in clinical settings. The FDA clearance and IVDR compliance also imply that the kit’s performance has been validated for its intended genetic analyses.

Are there multiple probe kits included in this product, and how do I determine which one to use for a patient?

This product bundle includes multiple FISH probe kits targeting different genetic abnormalities (e.g., MLL breakapart, AML1/ETO fusion, P53 deletion, etc.). The choice depends on the clinical suspicion or diagnostic workflow—your lab should consult guidelines (e.g., NCCN or local protocols) or genetic testing requests to select the appropriate probe(s) based on the patient’s symptoms, disease type (e.g., AML subtype), or prior genetic testing results. Always follow your lab’s established protocols for probe selection.

Does this kit require special handling or storage conditions, and what should I consider before use?

While specific storage conditions aren’t detailed here, FISH probe kits like this typically require protection from light, extreme temperatures, and contamination. Check the manufacturer’s instructions for exact storage guidelines (e.g., refrigeration or freezing). Additionally, since the kit is for laboratory use, ensure your facility has the necessary equipment (e.g., fluorescence microscope, hybridization ovens) and trained personnel to prepare and interpret the results accurately. Always follow your lab’s SOPs for reagent handling.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cytocell, Ltd.

Sources (2)

  • FDA 510(k) DEN170070 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026