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510(k) DEN170070

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 by Cytocell, Ltd. — Product Code QDI

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: December 21, 2018
Date Received: September 29, 2017
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies
Device Class: Class II
Regulation Number: 864.1880
Review Panel: PA
Submission Type

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.