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Synchron Systems Creatinine Reagent

by Beckman Coulter, Inc.

510(k) K071283

Active European Union and United States

CE IVDR 510(k)

Valid until

No date given

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) K071283↗

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 · Special NumberK071283 Date1 Jun 2007ClearedStatusActive
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  • Withdrawn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
CGX
Device class
Class II
Regulation
21 CFR Part 862.1225
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Creatinine Reagent is an in vitro diagnostic reagent kit designed for quantitative measurement of creatinine in serum, plasma, or urine. It employs alkaline picrate colorimetry to determine creatinine levels, functioning as a direct replacement for original equipment manufacturer (OEM) reagents on Beckman Synchron analyzers, including the CX and CX Delta systems.

This reagent is supplied as a kit containing two liquid components—an alkaline buffer and picric acid—which are mixed to form the working reagent. It is intended for use in clinical chemistry laboratories and is classified as a Class II medical device under FDA regulations (510(k) clearance) and the In Vitro Diagnostic Regulation (IVDR). The product is not described as single-use or reusable, nor is MRI safety or sterility specified in the provided data.

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Questions

AI-generated answers, 18 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 chemistry analyzers is this creatinine reagent designed to replace original equipment manufacturer (OEM) reagents on?

    The Synchron Systems Creatinine Reagent is specifically designed as a direct replacement for OEM reagents on Beckman Synchron analyzers, including the CX and CX Delta systems. This ensures compatibility with these platforms for quantitative creatinine measurement.

  • How is the Synchron Systems Creatinine Reagent supplied, and what components does the kit include?

    The reagent is supplied as a kit containing two liquid components: an alkaline buffer and picric acid. These components must be mixed to form the working reagent before use in clinical chemistry laboratories.

  • What analytical method does this reagent use to measure creatinine levels, and what sample types can it analyze?

    The reagent employs alkaline picrate colorimetry to quantitatively measure creatinine levels. It is intended for use with serum, plasma, or urine samples, making it versatile for various clinical chemistry applications.

  • Is there any information provided about whether this reagent is single-use or reusable?

    The provided data does not explicitly state whether the Synchron Systems Creatinine Reagent is single-use or reusable. It is important to follow manufacturer guidelines or laboratory protocols for proper usage and disposal.

  • What regulatory pathways has this device undergone, and what classification does it hold?

    The Synchron Systems Creatinine Reagent has received FDA 510(k) clearance and complies with the In Vitro Diagnostic Regulation (IVDR). It is classified as a Class II medical device under FDA regulations, indicating a higher level of scrutiny due to its role in clinical chemistry testing.