510(k) · Cleared
ClearedBCR-ABL1 (p210) % IS Kit (Digital PCR Method)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Sniper Medical Technologies Co., Ltd. · OYX Bcr/Abl1 Monitoring Test
Cleared on Sep 5, 2023 as substantially equivalent to K181661 (Bio-Rad Laboratories, Inc., 2019) after a 434-day review. Its family tree reaches back 3 generations to 2008.
- Decided
- Sep 5, 2023
- Review
- 434 days
- Class
- Class II
- Product code
- OYX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K082562 (2008). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK082562 Applied Biosystems 7500 Fast DXApplied Biosystems, Inc. · 2008
- 2 generations backK141220 Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS…Thermo Fisher Scientific (Life Technologies Holdin · 2014
- 1 generation backK181661 QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc. · 2019 · Recalled
- This deviceK221869 BCR-ABL1 (p210) % IS Kit (Digital PCR Method)Suzhou Sniper Medical Technologies Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K082562 | Applied Biosystems 7500 Fast DX | Applied Biosystems, Inc. | 2008 | — |
| −2 | K141220 | Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS Software | Thermo Fisher Scientific (Life Technologies Holdin | 2014 | — |
| −1 | K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | Bio-Rad Laboratories, Inc. | 2019 | 1 |
| 0 (this device) | K221869 | BCR-ABL1 (p210) % IS Kit (Digital PCR Method) | Suzhou Sniper Medical Technologies Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OYX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OYX device
- #1 K252243 Fastplex™ BCR-ABL (p210) %IS digital PCR Kitscore 12.2 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemSummary page 4…lassification/Advisory Panel Pathology (88) C. Predicate device: Product Name: QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System 510(k) Number: K181661 Product Code: OYX, PHG Manufacture: Bio-Rad Laboratories, Inc. D. Indications for Use: 1. Indications for use:… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K181661.
How does its category compare?
All OYX devicesOYX Bcr/Abl1 Monitoring Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OYX
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OYX
Too few OYX 510(k)s in any year since 2007 to give a median.
Recalls per year · OYX
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OYX
4in 2025
MAUDE reports naming product code OYX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BCR-ABL1 (p210) %IS Kit (Digital PCR Method) is an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t (9;22) positive Chronic Myeloid Leukemia (CML) adult patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The BCR-ABL1 (p210) %IS Kit (Digital PCR Method) is a reverse transcription-quantitative PCR performed on the Sniper Digital PCR…
Read the full statement (163 words)
The BCR-ABL1 (p210) %IS Kit (Digital PCR Method) is an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t (9;22) positive Chronic Myeloid Leukemia (CML) adult patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The BCR-ABL1 (p210) %IS Kit (Digital PCR Method) is a reverse transcription-quantitative PCR performed on the Sniper Digital PCR All-in-One System and is intended to measure BCR-ABL1 to ABL1, expressed as a log molecular reduction (MR value) from a baseline of 100% on the International Scale, in t (9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs).
The BCR-ABL1 (p210) %IS Kit (Digital PCR Method) is intended for use only on the Sniper Digital PCR All-in-One System.
The test does not differentiate between e13a2 or e14a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t (9;22). This test is not intended for the diagnosis of CML.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221869 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221869: BCR-ABL1 (p210) % IS Kit (Digital PCR Method).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221869
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026