| Device |
chronic lymphocytic leukemia fish probe kit |
| Regulation Description |
Gene expression profiling test system for breast cancer prognosis. |
| Definition |
The CLL FISH Probe Kit is intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia (CLL). The assay may be used to dichotomize CLL (the 13q-, +12, or normal genotype group versus the 11q- or 17p- group) and may be used as an aid in determining disease prognosis in combination with additional biomarkers, morphology and other clinical information. |
| Physical State |
Reagents for B-cell chronic lymphocytic leukemia prognosis |
| Technical Method |
Fluorescent in situ hybridization |
| Target Area |
B-cell chronic lymphocytic leukemia |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Pathology |
|---|
| Product Code | OVQ |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.6040
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
|
Third Party Review
|
Accredited Persons
|
