meddevicedb.com FDA Device Reference

MLL (KMT2A) Breakapart FISH Probe Kit; 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

DEN170070 Class II Direct
Decision Date
2018-12-21
Sponsor / Applicant
Cytocell, Ltd.

Technical Specification

510(k) Submission ID DEN170070
Product Code QDI
Medical Specialty / Panel Medical Genetics
Regulation Citation 21 CFR 864.1880
Decision Date 2018-12-21
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

MLL (KMT2A) Breakapart FISH Probe Kit; 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 received FDA 510(k) clearance under submission number DEN170070, sponsored by Cytocell, Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Medical Genetics review panel. The statutory decision date of record is 2018-12-21.

Classification & Regulation

This clearance is catalogued under FDA product code QDI and 21 CFR 864.1880, within the Medical Genetics review panel as a Class II device.