| Device |
kit d816v mutation detection system |
| Definition |
A KIT D816V mutation detection system is an in vitro diagnostic test intended for qualitative detection of KIT D816V mutational status from fresh bone marrow samples of patients with aggressive systemic mastocytosis using nucleic acid amplification and real time detection systems. The KIT D816V mutation detection system is indicated as an aid in the selection of aggressive systemic mastocytosis patients for whom Gleevec® (imatinib mesylate) treatment is being considered. |
| Physical State |
Test consists of reagents, instrumentation, software and instructions needed to perform the test method. |
| Technical Method |
The device utilizes in vitro amplification and the detection of genomic DNA representing a somatic gene mutation from a cancerous hematologic specimen of interest. |
| Target Area |
Human peripheral blood or bone marrow specimens |
| Review Panel |
Pathology |
|---|
| Product Code | SGD |
|---|
| Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
HDE - Humanitarian Device Exemption
|
|---|
| Device Class |
HDE
|
| 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 |
