QDI — Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies Class II

FDA Device Classification

Classification Details

Product Code
QDI
Device Class
Class II
Regulation Number
864.1880
Submission Type
Review Panel
PA
Medical Specialty
Medical Genetics
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN170070cytocellMLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, PDecember 21, 2018