510(k) DEN170070
DEN170070 is an FDA 510(k) premarket notification submitted by Cytocell, Ltd. for the device "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". The FDA issued a decision of De Novo Granted on December 21, 2018. The device falls under product code QDI (Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies), a Class II device regulated under 21 CFR 864.1880.
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.