# K993980: Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409UL

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Feb 1, 2000 after 69 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: 1 generation back to K903153 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903153: Emit Ethyl Alcohol Assay, Syva Co. (1990) Summary page 1.

## Most influential descendants
- K013538: Ethanol (2001), 0 descendants of its own

## Indications for use
The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in the quantitative analysis of ethyl alcohol (ethanol) in human urine, plasma, and serum. The Emit® II Plus Ethyl Alcohol Assay is designed for use with most clinical chemistry analyzers.

Source page: https://510kreport.com/device/K993980
Methodology: https://510kreport.com/methodology