The CheckPoint breath alcohol test and the Alco-Breath Tube alcohol test received FDA 510-k clearance in April 2011. The FDA clearance is for over-the-counter (OTC) use, which means that the devices may be sold directly to consumers. By regulation, devices that have FDA over-the-counter clearance also have CLIA waived status.
To receive FDA clearance AlcoPro demonstrated to the FDA that untrained users could learn to use the devices and get accurate results just by reading the instructions. Our customers will appreciate the additional information and illustrations in the new instruction sheets that provide much clearer directions for using the devices and interpreting the results.
The CheckPoint device is a pass/fail device available in 0.02, 0.04, 0.05, and 0.08 % BAC cut-off levels. An optional blow bag can be used to ensure each user blows the same amount of breath through the device. See the new CheckPoint instruction sheet here. Click here to order the CheckPoint device.
The Alco-Breath Tube gives semi-quantitative results up to 0.15 % BAC and 0.08 % BAC. See the new Alco-Breath Tube 0.15% instruction sheet here, and the Alco-Breath Tube 0.08% instruction sheet here. Click here to order the Alco-Breath Tube device.