510(k) DEN160003
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 22, 2016
- Date Received
- January 19, 2016
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bcr/Abl1 Monitoring Test
- Device Class
- Class II
- Regulation Number
- 866.6060
- Review Panel
- PA
- Submission Type
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.