# K972011: Opus Ethanol

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Jul 22, 1997 after 53 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: 1 generation back to K871645 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871645: TDXR Rea (TM) Ethanol, Abbott Laboratories (1987) Summary page 1.

## Indications for use
OPUS Ethanol is an in vitro diagnostic thin film-based, fluorescence inhibition test for the quantitative measurement of ethanol in human serum or plasma as an aid in the diagnosis and treatment of alcohol intoxication and poisoning. OPUS Ethanol is intended for use with the OPUS analyzers.

Source page: https://510kreport.com/device/K972011
Methodology: https://510kreport.com/methodology