# K093458: Synchron Systems Enzymatic Creatinine (CR-E) Reagent, Model A60298

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 4, 2009 after 28 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K091742 (2009). 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)
- K091742: Synchron Systems Enzymatic Creatinine (CR-E) Reagent, Model A60298, Beckman Coulter, Inc. (2009) Summary page 1.

## Recalls of this device
- Apr 3, 2017 · Class II · Z-2080-2017: Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.

## Indications for use
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.

Source page: https://510kreport.com/device/K093458
Methodology: https://510kreport.com/methodology