# K102225: Alco-Breath Tube, Checkpoint Breath Alcohol Test

- Pathway: 510(k) (Traditional)
- Applicant: Alcopro, Inc.
- Decided: Apr 6, 2011 after 240 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 CheckPoint breath alcohol test is a device to test for alcohol in human breath, It is a disposable device designed for one-time use and is a screening test that gives preliminary results. The test is available at cut-offs of 0.02, 0.04, 0.05, and 0.08% BAG. The Alco-Breath Tube is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. This device provides a semi-quantitative estimate of alcohol levels in breath. The ABT-08 device gives readings between 0 and 0.08% BAG and the ABT-1 5 device gives readings between 0 and 0.15% BAG.

Source page: https://510kreport.com/device/K102225
Methodology: https://510kreport.com/methodology