# K060935: Synchron Systems Creatinine (Crea) Reagent

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Apr 28, 2006 after 23 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K883181 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042291: Unicel DXC 600 and 800 Synchron Systems, Beckman Coulter, Inc. (2004) Summary page 1.

## Indications for use
CREA reagent, when used in conjunction with UniCel® DxC 600/800 System(s), and SYNCHRON® Systems Multi Calibrator, is intended for the quantitative determination of Creatinine concentration in human serum, plasma or urine. 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/K060935
Methodology: https://510kreport.com/methodology