| Device |
leukemia translocation panel multiplex test |
| Definition |
The leukemia translocation panel multiplex test is a qualitative in vitro diagnostic device intended to identify specific fusion transcripts by reverse-transcriptase polymerase chain reaction (rt-pcr) from whole blood or bone marrow. It is intended for use as an aid in the diagnosis of recurrent balanced or reciprocal translocation positive acute and chronic myeloid leukemia, acute lymphocytic or promyelocytic leukemias. |
| Physical State |
Mulitplex qualitative chromosome translocation amplification test system. Should not include products not intended for export only or for products intended for re-importation into the USA |
| Technical Method |
The test uses a multiplex reverse-transcriptase polymerase chain reaction (RT-PCR) with multiplex fluorescent real-time PCR or bead-based array detection system |
| Target Area |
Peripheral human whole blood or bone marrow |
| Review Panel |
Immunology |
|---|
| Product Code | OYY |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Immunology and Hematology Devices
(DIHD)
|
|
Not Classified Reason
|
For Export Only
|
|---|
| Submission Type |
Contact ODE
|
|---|
| Device Class |
Not Classified
|
| 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 |
Not Third Party Eligible |
