# K013538: Ethanol

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Dec 14, 2001 after 51 days
- Product code: DML (Nad-Nadh, Specific Reagent For Alcohol 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 K903153 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993980: Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409UL, Syva Co. (2000) Summary page 1.

## Indications for use
The Ethanol assay is used for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine. The Ethanol assay should be exclusively used to detect ethanol and not other alcohols such as isopropanol or methanol. Reactivity with compounds structurally unrelated to ethanol has not been observed.

Source page: https://510kreport.com/device/K013538
Methodology: https://510kreport.com/methodology