Ethanol Assay for the Bayer Advia Integrated Module System

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K023184 ↗

FDA Product Code

DIC

Device Class

Class II

Regulation

21 CFR Part 862.3040

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K020794 Active Cleared 11 Jul 2002

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  FDA 510(k) K033379 Active Cleared 19 Dec 2003

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• Bayer Special Chemistry Calibrators

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  FDA 510(k) K022178 Active Cleared 12 Nov 2002

See all devices from Bayer Diagnostics Corp. →

• What is the ethanol assay for the Bayer Advia Integrated Module System used for?

  This assay is an in vitro diagnostic reagent intended for the quantitative measurement of ethanol concentration in human serum or plasma (lithium heparin). It is used to diagnose ethanol toxicity and overdose by measuring alcohol levels via an enzyme-based method specific to ethanol.

• How is the ethanol assay supplied and what system is it designed for?

  The assay is supplied as a reagent for use exclusively with the Bayer Advia Integrated Module System. It is formatted to integrate with this automated platform for clinical laboratory testing of ethanol in serum or plasma samples.

• Is the ethanol assay for the Bayer Advia system a single-use or reusable reagent?

  The reagent is intended for single-use in diagnostic testing. Each test consumes the reagent components, and it is not designed for reuse after initial application, consistent with standard in vitro diagnostic reagents for enzymatic assays.

• What regulatory pathway was used for the ethanol assay on the Bayer Advia system?

  The assay received FDA 510(k) clearance under submission K023184 on November 18, 2002, following a traditional review process. It was found substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device.