510(k) · Cleared
Recalled · Class II · 2017Synchron Systems Salicylate Reagent and Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · DKJ Colorimetry, Salicylate
Cleared on Feb 15, 2002 as substantially equivalent to K844070 (Abbott Laboratories, 1984) after a 57-day review. Its family tree reaches back 1 generation to 1984. It has been recalled 2 times.
- Decided
- Feb 15, 2002
- Review
- 57 days
- Class
- Class II
- Product code
- DKJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K844070 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK844070 TDX SalicylateAbbott Laboratories · 1984 · Recalled
- This deviceK014173 Synchron Systems Salicylate Reagent and CalibratorBeckman Coulter, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844070 | TDX Salicylate | Abbott Laboratories | 1984 | 1 |
| 0 (this device) | K014173 | Synchron Systems Salicylate Reagent and Calibrator | Beckman Coulter, Inc. | 2002 | — |
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 DKJ? 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 |
|---|---|---|---|
| * | K844070 | TDX SalicylateSummary page 1…(21 CFR § 862.3200) 4.0 Predicate Device(s): Beckman Coulter Predicate Manufacturer Docket Number SYNCHRON® Systems TDx® Salicylate Assay | Abbott Laboratories, Inc.* | K844070 Salicylate (SALY) Reagent *Abbott Laboratories, Inc., Abbott Park, IL 5.0 Description: The SYNCHRON System Salicylate (SALY) Reag… | 1984 |
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-2084-2017 | 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. |
| Oct 22, 2007 | Not classified | Z-2238-2009 | Nonconforming Material/Component | The Salicylate Reagent lots listed here may fail calibration and/or fail to maintain linearity at the upper end of analytical range. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K844070.
How does its category compare?
All DKJ devicesDKJ Colorimetry, Salicylate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKJ
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · DKJ
Too few DKJ 510(k)s in any year since 2007 to give a median.
Recalls per year · DKJ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKJ
1in 2020
MAUDE reports naming product code DKJ, 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 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Salicylate (SALY) Reagent, when used in conjunction with SYNCHRON® Systems Salicylate Calibrator, is intended for the quantitative determination of salicylate in serum and plasma on Beckman Coulter's SYNCHRON Systems by a colorimetric timed-endpoint method. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.
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/K014173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014173: Synchron Systems Salicylate Reagent and Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014173
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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