# K023184: Ethanol Assay for the Bayer Advia Integrated Module System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Nov 18, 2002 after 55 days
- Product code: DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method)
- Device class: 2
- Regulation: 21 CFR 862.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TDx/Ethanol: named in the summary without a submission number

## Indications for use
The Bayer ADVIA IMS Ethanol method is an in vitro diagnostic device intended to quantitatively measure ethanol (alcohol) levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of ethanol toxicity and overdose.

Source page: https://510kreport.com/device/K023184
Methodology: https://510kreport.com/methodology