OYX — Bcr/Abl1 Monitoring Test Class II
Classification Details
- Product Code
- OYX
- Device Class
- Class II
- Regulation Number
- 866.6060
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Medical Genetics
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221869 | suzhou sniper medical technologies co | BCR-ABL1 (p210) % IS Kit (Digital PCR Method) | September 5, 2023 |
| K190076 | cepheid | Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert I | September 27, 2019 |
| K181661 | bio-rad laboratories | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | February 13, 2019 |
| K173492 | molecularmd corporation | MRDx BCR-ABL Test, MRDx BCR-ABL Test Software | December 22, 2017 |
| DEN160003 | asuragen | Quantidex qPCR BCR-ABL IS Kit | July 22, 2016 |