# K181553: Immunalysis Ethyl Alcohol Enzyme Assay

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Oct 31, 2018 after 140 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
Longest line of descent: 2 generations back to K903152 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032461: Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221, Lin-Zhi International, Inc. (2003) Summary page 4.

## Indications for use
The Immunalysis Ethyl Alcohol Enzyme Assay is an in vitro diagnostic device for the quantitative analysis of ethyl alcohol (ethanol) in human urine, serum or plasma with automated clinical chemistry analyzers. The measurement of ethanol is used for the diagnosis and treatment of alcohol intoxication and poisoning. This assay is calibrated against ethyl alcohol. This device is intended for prescription use only.

Source page: https://510kreport.com/device/K181553
Methodology: https://510kreport.com/methodology