QDI — Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies Class II
FDA product code QDI covers "Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies", a Class II medical device regulated under 21 CFR 864.1880. Submissions are reviewed by the Medical Genetics panel. At least 1 recent 510(k) clearance has been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN170070 | cytocell | MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P | December 21, 2018 |