# K972725: Alcohol Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Sep 25, 1997 after 66 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
The alcohol reagent set is for the quantitative determination of ethyl alcohol in serum or whole blood. Alcohol analysis is most frequently requested for emergency room patients to aid in the differential diagnosis of central nervous system depression, which can be due to alcohol intoxication. It is also requested for forensic medicine purposes.

Source page: https://510kreport.com/device/K972725
Methodology: https://510kreport.com/methodology