OYX
6 FDA 510(k) clearances · Product code
254 daysmedian time to decision
434 days90th percentile
6clearances measured
FDA profile
- Official device name
- Bcr/Abl1 Monitoring Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6060
- Medical specialty
- Medical Genetics
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Fastplex™ BCR-ABL (p210) %IS digital PCR Kit (K252243) | Suzhou Precigenome, Ltd. Co; | 2026-07-02 |
| BCR-ABL1 (p210) % IS Kit (Digital PCR Method) (K221869) | Suzhou Sniper Medical Technologies Co., Ltd. | 2023-09-05 |
| Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems (K190076) | Cepheid | 2019-09-27 |
| QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (K181661) | Bio-Rad Laboratories, Inc. | 2019-02-13 |
| MRDx BCR-ABL Test, MRDx BCR-ABL Test Software (K173492) | Molecularmd Corporation | 2017-12-22 |
| Quantidex qPCR BCR-ABL IS Kit (DEN160003) | Asuragen, Inc. | 2016-07-22 |
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Every clearance here is in the API, with alerts when new ones post.