510(k) · Cleared
ClearedFastplex™ BCR-ABL (p210) %IS digital PCR Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Precigenome, Ltd. Co; · OYX Bcr/Abl1 Monitoring Test
Cleared on Jul 2, 2026 as substantially equivalent to K181661 (Bio-Rad Laboratories, Inc., 2019) after a 349-day review. Its family tree reaches back 3 generations to 2008.
- Decided
- Jul 2, 2026
- Review
- 349 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 deviceK252243 Fastplex™ BCR-ABL (p210) %IS digital PCR KitSuzhou Precigenome, Ltd. Co; · 2026
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) | K252243 | Fastplex™ BCR-ABL (p210) %IS digital PCR Kit | Suzhou Precigenome, Ltd. Co; | 2026 | — |
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 K221869 BCR-ABL1 (p210) % IS Kit (Digital PCR Method)score 6.6 · 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 10…e(s): QXDx BCR-ABL %IS Kit QXDx Automated Droplet Generator QXDx Droplet Reader QXDx Software 1.0 2. Predicate 510(k) number(s): K181661 3. Comparison with predicate: Similarities Item… | 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 18 years and passes through 4 companies; a new generation was cleared every 5.6 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. 2026, 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 Fastplex™ BCR-ABL (p210) % IS digital PCR Kit 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) patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The Fastplex™ BCR-ABL (p210) % IS digital PCR Kit is a reverse transcription-quantitative PCR performed on the RainSure DropMDx digital PCR…
Read the full statement (162 words)
The Fastplex™ BCR-ABL (p210) % IS digital PCR Kit 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) patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The Fastplex™ BCR-ABL (p210) % IS digital PCR Kit is a reverse transcription-quantitative PCR performed on the RainSure DropMDx digital PCR 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 Fastplex™ BCR-ABL (p210) % IS digital PCR Kit is intended for use only on the RainSure DropMDx digital PCR 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/K252243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252243: Fastplex™ BCR-ABL (p210) %IS digital PCR Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252243
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026