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ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer

by Beckman Coulter, Inc.

510(k) K161837

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) K161837↗

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 NumberK161837 Date16 Dec 2016ClearedStatusActive
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  • Withdrawn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
JGS
Device Class
Class II
Regulation
21 CFR Part 862.1665
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.

This device is a reagent for use with the DxC 700 AU Clinical Chemistry Analyzer, designed for in vitro diagnostic measurement of glucose, C-reactive protein (CRP) via latex agglutination, and ion-selective electrode (ISE) analysis of electrolytes. It falls under the category of electrodes, ion-specific and supports automated clinical chemistry testing for biochemical parameters in serum or plasma samples.

The reagent is supplied as part of a consumable kit for use in clinical laboratories, compatible exclusively with the DxC 700 AU analyzer. It is intended for single-use only and requires no sterilization beyond manufacturer-provided packaging. The device has received FDA 510(k) clearance and IVDR conformity, adhering to regulatory standards for in vitro diagnostics. Storage conditions and expiration dates are specified on the packaging.

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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 parameters does this reagent measure, and how does it perform those measurements?

    This reagent is designed for the DxC 700 AU Clinical Chemistry Analyzer to measure glucose levels, C-reactive protein (CRP) via latex agglutination, and electrolytes using ion-selective electrode (ISE) technology. Glucose is quantified biochemically, CRP is detected through latex agglutination (a turbidimetric immunoassay), and electrolytes are analyzed via ISE, which measures ion-specific conductivity in serum or plasma samples.

  • Is this reagent intended for single-use or reusable applications, and what are the handling requirements?

    The reagent is explicitly intended for single-use only and does not require additional sterilization beyond the manufacturer-provided packaging. It is supplied as part of a consumable kit exclusively for the DxC 700 AU analyzer, meaning each unit is designed for one-time use in automated clinical chemistry testing.

  • How should this reagent be stored, and what information is provided regarding expiration?

    Storage conditions and expiration dates are clearly indicated on the packaging. While the exact details (e.g., temperature range, light exposure) are not specified here, the manufacturer’s instructions on the label must be followed to ensure stability and accuracy. Always verify the expiration date before use to maintain regulatory compliance and test reliability.

  • What regulatory pathways has this reagent undergone, and which standards does it comply with?

    This reagent has received FDA 510(k) clearance under the Traditional pathway (K161837) and IVDR conformity, adhering to EU regulatory standards for in vitro diagnostics. The submission was reviewed by the FDA’s Clinical Chemistry (CH) Advisory Committee and classified under product code JGS, reflecting its role in automated biochemical analysis. Compliance ensures its suitability for clinical laboratory use in the U.S. and EU markets.