# K014173: Synchron Systems Salicylate Reagent and Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Feb 15, 2002 after 57 days
- Product code: DKJ (Colorimetry, Salicylate)
- Device class: 2
- Regulation: 21 CFR 862.3830
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K844070 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844070: TDX Salicylate, Abbott Laboratories (1984) Summary page 1.

## Recalls of this device
- Apr 3, 2017 · Class II · Z-2084-2017: 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: The Salicylate Reagent lots listed here may fail calibration and/or fail to maintain linearity at the upper end of analytical range.

## Indications for use
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.

Source page: https://510kreport.com/device/K014173
Methodology: https://510kreport.com/methodology