Bcr/Abl1 Monitoring Test
The BCR/ABL1 Monitoring Test is a quantitative in vitro diagnostic device that uses reverse-transcriptase quantitative PCR (RQ-PCR) to monitor the BCR/ABL1 to ABL1 ratio in whole blood or bone marrow of Philadelphia chromosome-positive chronic myeloid leukemia (CML) patients, reporting results on the international scale (%IS) and as log molecular reduction (MR) values to assess treatment response. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OYX, with regulation number 866.6060 under the Medical Genetics specialty, reviewed by the pathology panel.
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Basic Information
- Product Code
- OYX
- Device Class
- FDA class 2
- Regulation Number
- 866.6060
- Medical Specialty
- Medical Genetics
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K221869 | BCR-ABL1 (p210) % IS Kit (Digital PCR Method) | Sep 05, 2023 | Substantially Equivalent | Suzhou Sniper Medical Technologies Co., Ltd. |
| K190076 | Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems | Sep 27, 2019 | Substantially Equivalent | Cepheid |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | Feb 13, 2019 | Substantially Equivalent | Bio-Rad Laboratories, Inc. |
| K173492 | MRDx BCR-ABL Test, MRDx BCR-ABL Test Software | Dec 22, 2017 | Unknown | Molecularmd Corporation |
| DEN160003 | Quantidex qPCR BCR-ABL IS Kit | Jul 22, 2016 | Unknown | Asuragen, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.