510(k) · Cleared
Recalled · Class II · 2024QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · OYX Bcr/Abl1 Monitoring Test
Cleared on Feb 13, 2019 as substantially equivalent to DEN160003 (Asuragen, Inc., 2016) and 1 other predicate after a 233-day review. Its family tree reaches back 2 generations to 2008. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 13, 2019
- Review
- 233 days
- Class
- Class II
- Product code
- OYX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K082562 (2008). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK082562 Applied Biosystems 7500 Fast DXApplied Biosystems, Inc. · 2008
- 1 generation backK141220 Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS…Thermo Fisher Scientific (Life Technologies Holdin · 2014
- This deviceK181661 QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK252243 Fastplex™ BCR-ABL (p210) %IS digital PCR KitSuzhou Precigenome, Ltd. Co; · 2026
- Descendant · cites it directly · 0 of its ownK221869 BCR-ABL1 (p210) % IS Kit (Digital PCR Method)Suzhou Sniper Medical Technologies Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K082562 | Applied Biosystems 7500 Fast DX | Applied Biosystems, Inc. | 2008 | — |
| −1 | K141220 | Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS Software | Thermo Fisher Scientific (Life Technologies Holdin | 2014 | — |
| 0 (this device) | K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | Bio-Rad Laboratories, Inc. | 2019 | — |
| +1 | K252243 | Fastplex™ BCR-ABL (p210) %IS digital PCR Kit | Suzhou Precigenome, Ltd. Co; | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | DEN160003 | Quantidex qPCR BCR-ABL IS KitSummary page 4…Notification QuantideX qPCR BCR-ABL IS Kit De Novo DEN160003 Applied Biosystems 7500 Fast Dx Real-Time PCR Class II K141220 Instrument with SDS Software 4. Device Description… | 2016 |
| * | K141220 | Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS SoftwareSummary page 4…qPCR BCR-ABL IS Kit De Novo DEN160003 Applied Biosystems 7500 Fast Dx Real-Time PCR Class II K141220 Instrument with SDS Software 4. Device Description 6-1 QXDx AutoDG ddPCR… | 2014 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 15, 2024 | Class II | Z-1358-2024 | Nonconforming Material/Component | Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K252243 (Suzhou Precigenome, Ltd. Co;, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate DEN160003.
How does its category compare?
All OYX devicesOYX Bcr/Abl1 Monitoring Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 QXDx™ BCR-ABL %IS 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 QXDx BCR-ABL %IS Kit is a reverse transcription-quantitative PCR performed on the Bio-Rad QXDx™ AutoDG™ ddPCR System and is intended to measure BCR-ABL1 to ABL1…
Read the full statement (150 words)
The QXDx™ BCR-ABL %IS 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 QXDx BCR-ABL %IS Kit is a reverse transcription-quantitative PCR performed on the Bio-Rad QXDx™ AutoDG™ ddPCR 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 QXDx BCR-ABL %IS Kit is intended for use only on the Bio-Rad QXDx AutoDG ddPCR 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/K181661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181661: QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181661
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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