Device |
fish based detection of chromosomal abnormalities from patients with hematologic malignancies |
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. |
Physical State |
The test kits may include fluorescence labeled DNA probes, hybridization buffers, and a counterstain |
Technical Method |
Fluorescence in situ hybridization |
Target Area |
Human bone marrow and peripheral blood specimens |
Regulation Medical Specialty |
Molecular Genetics |
Review Panel |
Pathology |
Product Code | QDI |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
Submission Type |
510(k)
|
Regulation Number |
864.1880
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|