# K993920: Ethanol-L3K Assay, Catalogue Number 273-30, 273-17

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Jan 18, 2000 after 61 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For the quantitative determination of ethanol in serum. For IN VITRO diagnostic use. Ethanol (ethyl alcohol) is the most common toxic substance involved in medical-legal cases. Ethanol consumption is often a factor in all types of accidents and ethanol poisoning can be fatal. Ethanol testing of comatose patients aids in the differential diagnosis of the cause of the coma. (1) Early methods for ethanol analysis depended on separation of the ethanol from the specimen. The method described here is an enzymatic procedure which does not require separation and is rapid and easily automated. This method is based on the first enzymatic method described by Bonnichsen and Theorelle (2) and later modified by other authors. (3) However, the current method is unique in that an aldehyde trap is no longer necessary in order to drive the reaction to completion. This is accomplished by the use of a co-factor with a high oxidizing potential. (4)

Source page: https://510kreport.com/device/K993920
Methodology: https://510kreport.com/methodology