# K071277: Synchron LX20 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K883181 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965240: Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX Creatinine Picric Reagent, Synchron L, Beckman Instruments, Inc. (1997) Summary page 1.

## Recalls of this device
- May 15, 2017 · Class II · Z-2730-2017: The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.

## Indications for use
The Beckman Coulter AQUA CAL 1, 2, and 3 are intended for use on SYNCHRON LX® and UniCel® DxC Systems for the calibration of Sodium, Potassium, Chloride, Urea Nitrogen, Urea, Glucose Creatinine, Calcium, Carbon Dioxide, and Phosphorus. CREm reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System and SYNCHRON® Systems AQUA CAL I and 2, is intended for the quantitative determination of Creatinine concentration in human serum, plasma or urine.

Source page: https://510kreport.com/device/K071277
Methodology: https://510kreport.com/methodology