# K990516: Ethyl Alcohol Clinical Standard Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Emd Chemicals, Inc.
- Decided: Mar 31, 1999 after 41 days
- Product code: DNN (Calibrators, Ethyl Alcohol)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: 3 (0 Class I)
- 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.

## Recalls of this device
- Mar 27, 2008 · Not classified · Z-1607-2008: Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard.
- Dec 13, 2002 · Not classified · Z-0684-03: The Ethanol Standard is OOS on the low end. The results were 0.44 mg/mL while the specification is 0.48-0.52 mg/mL.
- Dec 13, 2002 · Not classified · Z-0683-03: The Ethanol Standard is OOS on the high end. The results were 1.58 mg/mL while the specification is 1.477-1.538 mg/mL.

## Indications for use
The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization of instruments and methods for the determination of Ethyl alcohol in whole blood or serum. The Standard Solutions may also be used for validation of the laboratory's routine standards and/or control materials.

Source page: https://510kreport.com/device/K990516
Methodology: https://510kreport.com/methodology