# K963197: ON.Site Alcohol

- Pathway: 510(k) (Traditional)
- Applicant: Ansys, Inc.
- Decided: Sep 19, 1996 after 35 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
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. The FDA summary names its predicate without a number.
- (no number) current ON-SITE Alcohol: named in the summary without a submission number

## Indications for use
ON-SITE Alcohol is recommended for professional use only and is not intended for over-the-counter sale to the general public. Professional use includes applications in healthcare, corrections and drug treatment. ON-SITE Alcohol yields only a "qualitative" result. A positive result indicates that alcohol (ethanol) is present at a concentration of approximately 0.02% when performed according to the instructions. Confirmation of ONSITE Alcohol results using gas chromatography is recommended if quantitative results are desired.

Source page: https://510kreport.com/device/K963197
Methodology: https://510kreport.com/methodology