| Device |
revumenib eligibility detection system |
| Definition |
A revumenib eligibility detection system is identified as a prescription in vitro diagnostic device intended for the qualitative detection of structural abnormalities of chromosome 11 in specimens from patients with acute leukemia for the purpose of identifying patients who may benefit from treatment with revumenib, in accordance with the approved therapeutic product labeling. |
| Physical State |
The test kits may include fluorescence labeled DNA probes, hybridization buffers, and a counterstain. Should not include devices using non-in situ hybridization methods or for devices intended for monitoring of residual disease. |
| Technical Method |
Bone marrow cells of interest are hybridized with nucleic acid probes for determining the presence KMT2A rearrangements using fluorescence in situ hybridization to determine drug therapeutic eligibility. Hybridization may be performed manually or using an automated stainer. |
| Target Area |
Human clinical hematolymphoid specimens |
| Regulation Medical Specialty |
Hematology |
| Review Panel |
Pathology |
|---|
| Product Code | SFS |
|---|
| Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
864.1885
|
|---|
| 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 |
Not Third Party Eligible |
