# K082080: Alco Tube Plus

- Pathway: 510(k) (Traditional)
- Applicant: Alcotest Quebec
- Decided: Apr 1, 2009 after 252 days
- Product code: DJZ (Devices, Breath Trapping, Alcohol)
- Device class: 1
- Regulation: 21 CFR 862.3050
- Recalls of this device: none
- 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 1.

## Indications for use
The Alco Tube Plus Alcohol Detector is an in vitro medical device to qualitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available in two cut-offs including 0.05 and 0.08 percent breath alcohol. The device is used only as a screening device .and is only an indication of the possible presence of alcohol in the blood of the test subject.

Source page: https://510kreport.com/device/K082080
Methodology: https://510kreport.com/methodology