# K071280: Synchron CX Delta Clinical Systems, Creatinine Test Systems

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 1, 2007 after 25 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: 1 generation back to K950958 (1995). 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)
- K950958: Synchon CX Delta Clin Syst (CX4, CX5, CX7 Delta), Beckman Instruments, Inc. (1995) Summary page 1.

## Indications for use
Beckman Coulter SYNCHRON CX Calibrators 1, 2, and 3 are to be used for calibrating SYNCHRON CX Delta, CX®CE, and CX PRO Systems only. CRE3 reagent, in conjunction with SYNCHRON CX® Delta Systems and SYNCHRON CX®Calibrators 1, 2 and 3 is intended for the quantitative determination of Creatinine (CRE3) in human serum, plasma or urine.

Source page: https://510kreport.com/device/K071280
Methodology: https://510kreport.com/methodology