510(k) · Cleared
Recalled · Class II · 2017Synchron Systems Enzymatic Creatinine (CR-E) Reagent, Model A60298
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JFY Enzymatic Method, Creatinine
Cleared on Dec 4, 2009 as substantially equivalent to K091742 (Beckman Coulter, Inc., 2009) after a 28-day review. Its family tree reaches back 1 generation to 2009. It has been recalled once.
- Decided
- Dec 4, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- JFY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K091742 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK091742 Synchron Systems Enzymatic Creatinine (CR-E) Reagent, Model A60298Beckman Coulter, Inc. · 2009 · Recalled
- This deviceK093458 Synchron Systems Enzymatic Creatinine (CR-E) Reagent, Model A60298Beckman Coulter, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K091742 | Synchron Systems Enzymatic Creatinine (CR-E) Reagent, Model A60298 | Beckman Coulter, Inc. | 2009 | 1 |
| 0 (this device) | K093458 | Synchron Systems Enzymatic Creatinine (CR-E) Reagent, Model A60298 | Beckman Coulter, Inc. | 2009 | — |
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 JFY? 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 JFY device
- #1 K252619 Qscheck Uisacrscore 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K091742 | Synchron Systems Enzymatic Creatinine (CR-E) Reagent, Model A60298Summary page 1…s substantial equivalence to the Beckman Coulter SYNCHRON Systems Enzymatic Creatinine (CR-E) reagent currently in commercial distribution, FDA 510(k) Number K091742. Candidate(s) Predicate Manufacturer Docket SYNCHRON Systems… | 2009 |
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 3, 2017 | Class II | Z-2080-2017 | Under Investigation by firm | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All JFY devicesJFY Enzymatic Method, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JFY
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JFY
59in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JFY
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFY
61in 2025
MAUDE reports naming product code JFY, 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 | 8 | 193 | 0 | 1 |
| 2008 | 4 | 170 | 2 | 4 |
| 2009 | 3 | 59 | 3 | 22 |
| 2010 | 0 | — | 3 | 22 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 1 | 39 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 56 |
| 2020 | 0 | — | 0 | 34 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 61 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
CR-E reagent, when used in conjunction with SYNCHRON® Systems, UniCel® DxC Systems and SYNCHRON® Systems AQUA CAL 1 and 2 and SYNCHRON CX® Calibrator Level 1 and 2, is intended for the quantitative determination of creatinine (CR-E concentration in human serum, plasma or urine (urine is not available on the SYNCHRON CX® PRO Systems).
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093458 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093458: Synchron Systems Enzymatic Creatinine (CR-E) Reagent, Model A60298.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093458
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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