# K093143: Mission Breath Alcohol Detector

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Jan 28, 2010 after 115 days
- Product code: DJZ (Devices, Breath Trapping, Alcohol)
- Device class: 1
- Regulation: 21 CFR 862.3050
- 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: 4 generations back to K041334 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060761: Breathscan, Breath and Breath Check Alcohol Detectors, Akers Biosciences, Inc. (2006) Summary page 2.

## Recalls of this device
- Jun 17, 2015 · Class III · Z-2322-2015: Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.

## Indications for use
The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicates relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08% or 0.10% cut-off levels. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

Source page: https://510kreport.com/device/K093143
Methodology: https://510kreport.com/methodology