Skip to content

Synchron Systems Cholinesterase (Chex) Model A53722

by Beckman Coulter, Inc.

510(k) K103373

Active European Union and United States

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103373↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK103373 Date7 Feb 2011ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DIH
Device Class
Class I
Regulation
21 CFR Part 862.3240
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Synchron Systems Cholinesterase (Chex) Model A53722 is a colorimetric reagent system designed for the quantitative determination of cholinesterase activity (E.C. 3.1.1.8) in human serum and plasma. This device falls under the nomenclature category of Colorimetry, Cholinesterase and is intended for use in clinical toxicology assessments.

This reagent system is supplied for use on Beckman Coulter’s Synchron CX Pro, Synchron LX Pro, and UniCel DxC 600/800 systems. It is classified under FDA product code DIH and is regulated under Class I – General Controls with an FDA 510(k) clearance (K103373). The device is intended for single-use and requires adherence to standard laboratory protocols for storage and handling.

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical applications is the Synchron Systems Cholinesterase (Chex) Model A53722 reagent system primarily used for in a lab setting?

    The Synchron Systems Cholinesterase (Chex) Model A53722 is designed for quantitative determination of cholinesterase activity in human serum and plasma, specifically within clinical toxicology assessments. This helps evaluate exposure to organophosphate or carbamate pesticides, which inhibit cholinesterase, or monitor patients with conditions affecting enzyme levels, such as liver disease or certain neurological disorders.

  • Which Beckman Coulter analyzers is this reagent system compatible with, and how is it supplied?

    The Synchron Systems Cholinesterase (Chex) Model A53722 is exclusively compatible with Beckman Coulter’s Synchron CX Pro, Synchron LX Pro, and UniCel DxC 600/800 systems. It is supplied as a colorimetric reagent system, meaning it relies on chemical reactions to produce measurable color changes for analysis, and is intended for single-use per the manufacturer’s instructions.

  • Is this reagent system sterile, and what storage conditions should be followed?

    The Synchron Systems Cholinesterase (Chex) Model A53722 is intended for single-use, but the data does not explicitly state whether it is sterile. Standard laboratory protocols for storage and handling should be followed, which typically include protecting reagents from extreme temperatures, light exposure, and contamination. Always refer to the manufacturer’s instructions for precise storage guidelines to maintain reagent integrity.

  • What regulatory pathway was followed for this device’s clearance, and what does that mean for its use?

    The Synchron Systems Cholinesterase (Chex) Model A53722 received FDA clearance through a 510(k) submission, classified under Product Code DIH and Class I – General Controls, with a decision of Substantially Equivalent (SESE). This means the device was determined to be as safe and effective as a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended use in clinical toxicology assessments on specified analyzers.