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AU Bicarbonate Reagent

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K131546

by Beckman Coulter Ireland Inc.

Identifiers

510(k) Number
K131546 FDA 510(k)
FDA Product Code
KHS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1160 FDA 510(k)
Regulation Number
862.1160 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The AU Bicarbonate Reagent is an enzymatic, carbon-dioxide measurement reagent designed for quantitative determination of bicarbonate levels in human serum and plasma. Classified under the nomenclature for enzymatic diagnostic reagents, it is intended for use with Beckman Coulter AU analyzers in clinical chemistry applications.

This reagent is supplied as a single-use, non-sterile liquid for in vitro diagnostic use. It is regulated under the FDA’s 510(k) pathway with a clearance type of Traditional and is authorized for use in clinical chemistry settings. The product is distributed under the product code KHS and adheres to regulatory standards outlined in 21 CFR 862.1160, with no third-party manufacturing involvement.

Frequently asked questions

What clinical chemistry applications is the AU Bicarbonate Reagent specifically designed for?

The AU Bicarbonate Reagent is designed for quantitative determination of bicarbonate levels in human serum and plasma using Beckman Coulter AU analyzers. It leverages enzymatic methods to measure carbon-dioxide levels, which is critical for assessing acid-base balance and metabolic disorders in clinical settings.

Is the AU Bicarbonate Reagent intended for single-use or reusable applications, and what does this mean for workflow?

The reagent is supplied as a single-use, non-sterile liquid, meaning each vial is intended for one measurement cycle. This design minimizes contamination risk and ensures consistent results, though it requires careful inventory management to avoid waste in high-volume labs.

How should the AU Bicarbonate Reagent be stored, and are there any special handling requirements?

While the data does not specify exact storage conditions, as a liquid reagent, it should typically be stored refrigerated (2–8°C) and protected from light to preserve stability. Always refer to the manufacturer’s instructions for precise details, as improper storage could compromise accuracy or shelf life.

What regulatory pathways does the AU Bicarbonate Reagent follow, and how does this affect its use in clinical settings?

The reagent is cleared via the FDA’s 510(k) pathway (Traditional clearance) and authorized under the In Vitro Diagnostic Regulation (IVDR). This means it meets U.S. and EU standards for safety and performance in clinical chemistry, ensuring compliance for use in accredited labs. The clearance type indicates it was deemed *substantially equivalent* to a predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AU BICARBONATE REAGENT (K131546) — FDA 510 (k) | Innolitics, Part | Beckman Coulter, BfArM - All news at a glance - Urgent Field Safety Notice for ..., AU BICARBONATE REAGENT 510 (k) K131546 - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Beckman Coulter Ireland Inc.
FDA Applicant
Beckman Coulter Ireland, Inc.

Sources (2)

  • FDA 510(k) K131546 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026