# K071811: Etoh Flex Reagent Cartridge (DF22)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 24, 2007 after 52 days
- Product code: DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method)
- Device class: 2
- Regulation: 21 CFR 862.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904302 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904302: Dupont Dimension (R) Ethyl Alcohol (Alc) Method, E.I. Dupont DE Nemours & Co., Inc. (1990) Summary page 1.
- K010960: Emit II Plus Ethyl Alcohol Assay, Model OSR9K229, Syva Co., Dade Behring, Inc. (2001) Summary page 1.

## Recalls of this device
- Feb 14, 2020 · Class II · Z-1599-2020: The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.

## Indications for use
The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol in human serum, plasma and urine. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.

Source page: https://510kreport.com/device/K071811
Methodology: https://510kreport.com/methodology