BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
FDA 510(k) K221869 · Suzhou Sniper Medical Technologies Co., Ltd.
Submission
- Device name
- BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
- Applicant
- Suzhou Sniper Medical Technologies Co., Ltd.
Suzhou, CN - Received
- June 28, 2022
- Decision date
- September 5, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OYX – Bcr/Abl1 Monitoring Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6060
- Specialty
- Medical Genetics
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…
Other 510(k)s with product code OYX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252243 | Fastplex BCR-ABL (p210) %IS digital PCR KitOYX · Traditional | Suzhou Precigenome, Ltd. Co; | 07/02/2026SE |
| K190076 | Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert…OYX · Traditional | Cepheid | 09/27/2019SE |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemOYX · Traditional | Bio-Rad Laboratories, Inc. | 02/13/2019SE |
| K173492 | MRDx BCR-ABL Test, MRDx BCR-ABL Test SoftwareOYX · Traditional | Molecularmd Corporation | 12/22/2017SESD |
Questions and answers
When was BCR-ABL1 (p210) % IS Kit (Digital PCR Method) cleared by the FDA?
BCR-ABL1 (p210) % IS Kit (Digital PCR Method) (K221869) received a 510(k) decision of Substantially Equivalent on September 5, 2023, 434 days after the submission was received.
What is the product code of K221869?
The FDA product code is OYX – Bcr/Abl1 Monitoring Test, a Class II (moderate risk) device regulated under 21 CFR 866.6060.