# K103373: Synchron Systems Cholinesterase (Chex) Model A53722

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Feb 7, 2011 after 82 days
- Product code: DIH (Colorimetry, Cholinesterase)
- Device class: 1
- Regulation: 21 CFR 862.3240
- 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 K030045 (2003). 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)
- K030045: Olympus Cholinesterase Reagent (Catalog Number OSR6114), Olympus America, Inc. (2003) Summary page 1.

## Indications for use
System reagent for the quantitative determination of Cholinesterase activity (E.C. 3.1.1.8) in human serum and plasma on Beckman Coulter Synchron CX® Pro System(s), Synchron LX® Pro System(s) and UniCel® DxC 600/800 System(s). Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

Source page: https://510kreport.com/device/K103373
Methodology: https://510kreport.com/methodology