| Device |
bcr/abl1 monitoring test |
| Regulation Description |
BCR-ABL quantitation test. |
| Definition |
A BCR/ABL1 Monitoring Test is a quantitative in vitro diagnostic device used to monitor the BCR/ABL1 to ABL1 ratio by reverse-transcriptase quantitative polymerase chain reaction (RQ-PCR) on whole blood or bone marrow of diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) patients expressing BCR-ABL1 fusion transcripts such as e13a2 and/or e14a2. It is intended for use during monitoring of treatment response by reporting results on the international scale (%IS) and as log molecular reduction (MR) value. |
| Physical State |
Multiplex quantitative RT-PCR assay to detect chromosome translocation fusion transcripts and control transcripts test system. |
| Technical Method |
The test uses multiplex reverse–transcriptase polymerase chain reaction to detect and determine BCR-ABL1 (such as e13a2 and/or e14a2) fusion transcript levels and quantifies them relative to levels of ABL1 transcript (or other validated control gene). The test may utilize other technologies and/or quantification methods. |
| Target Area |
Peripheral human whole blood or bone marrow. |
| Regulation Medical Specialty |
Molecular Genetics |
| Review Panel |
Pathology |
|---|
| Product Code | OYX |
|---|
| Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.6060
|
|---|
| 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 |
Not Third Party Eligible |
