510(k) · Cleared
Recalled · 2003Modification to Synchron Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Oct 16, 2001 as substantially equivalent to K003488 (Beckman Coulter, Inc., 2000) after an 18-day review. Its family tree reaches back 1 generation to 2000. It has been recalled once.
- Decided
- Oct 16, 2001
- Review
- 18 days
- Class
- Class I
- Product code
- JJY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003488 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK003488 Synchron ControlBeckman Coulter, Inc. · 2000
- This deviceK013235 Modification to Synchron ControlBeckman Coulter, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003488 | Synchron Control | Beckman Coulter, Inc. | 2000 | — |
| 0 (this device) | K013235 | Modification to Synchron Control | Beckman Coulter, Inc. | 2001 | — |
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 JJY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K003488 | Synchron ControlSummary page 2…and imprecision. Comparison to Predicate(s): The modified SYNCHRON Control claims substantial equivalence to the SYNCHRON Control currently in commercial distribution (K003488). The modified SYNCHRON Control contains vancomycin and the current product does not. Summary of Performance Data: Stress stab… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2003 | Not classified | Z-1151-04 | Other | The quality control samples for Vancomycin would not recover correctly when compared to the S.I. unit values listed in the incorrectly printed product insert. The incorrectly printed values were higher than they should be by a factor of 3… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
SYNCHRON® Controls are made from stabilized human serum and are designed
to monitor the performance of SYNCHRON Systems in the clinical laboratory.
SYNCHRON Control levels, 1, 2, and 3 bear a quantitative relationship to each
other: Level 2 is manufactured by combining equal quantities of levels 1 and 3.
The use of three levels enable the laboratorian to monitor changes in calibration
and linearity along with analytical error and imprecision.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013235: Modification to Synchron Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013235
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026