FDA product code OYX: Bcr/Abl1 Monitoring Test
OYX is the FDA product code for bcr/abl1 monitoring test. It is a Class II device, regulated under 21 CFR 866.6060 and reviewed by the Pathology panel. FDA has cleared 5 510(k) submissions under OYX, 2 in the last five years, from 5 different applicants. The average 510(k) review took 262 days (median 254); 349 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 3 recalls for OYX devices, 3 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Bcr/Abl1 Monitoring Test |
| Device class | Class II |
| Regulation | 21 CFR 866.6060 |
| Review panel | PA — Pathology |
| Medical specialty | Medical Genetics |
| Premarket route | 510(k) |
510(k) clearances per year for OYX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 39 |
| 2019 | 2 | 244 |
| 2023 | 1 | 434 |
| 2026 | 1 | 349 |
Compare with all 510(k) review times · Search every OYX clearance
Top OYX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Suzhou Precigenome, Ltd. Co; | 1 | 2026-07-02 |
| Suzhou Sniper Medical Technologies Co., Ltd. | 1 | 2023-09-05 |
| Cepheid | 1 | 2019-09-27 |
| Bio-Rad Laboratories, Inc. | 1 | 2019-02-13 |
| Molecularmd Corporation | 1 | 2017-12-22 |
Most recent OYX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252243 | Suzhou Precigenome, Ltd. Co; | Fastplex BCR-ABL (p210) %IS digital PCR Kit | 2026-07-02 | 349 |
| K221869 | Suzhou Sniper Medical Technologies Co., Ltd. | BCR-ABL1 (p210) % IS Kit (Digital PCR Method) | 2023-09-05 | 434 |
| K190076 | Cepheid | Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems | 2019-09-27 | 254 |
| K181661 | Bio-Rad Laboratories, Inc. | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | 2019-02-13 | 233 |
| K173492 | Molecularmd Corporation | MRDx BCR-ABL Test, MRDx BCR-ABL Test Software | 2017-12-22 | 39 |
Recalls for OYX devices
3 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-10-30.
| Year | Recalls |
|---|---|
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code OYX?
OYX is the FDA product code for bcr/abl1 monitoring test. It is a Class II device, regulated under 21 CFR 866.6060 and reviewed by the Pathology panel.
What device class is OYX?
Class II, regulation 21 CFR 866.6060. Typical premarket route: 510(k).
How long does a 510(k) take for product code OYX?
Across 5 cleared submissions the average was 262 days from receipt to decision (median 254).
Which companies have the most OYX clearances?
Suzhou Precigenome, Ltd. Co; (1); Suzhou Sniper Medical Technologies Co., Ltd. (1); Cepheid (1); Bio-Rad Laboratories, Inc. (1); Molecularmd Corporation (1).
Have OYX devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2025-10-30.
Next steps
- Run an FDA pathway report with predicate devices for product code OYX
- Run a recall and safety report across every OYX manufacturer
- Watch product code OYX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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