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Breath Alcohol Screen disposable breath alcohol FDA cleared for OTC device image

AlcoCheck Breath Alcohol Screen disposable device 510(k) cleared for OTC

Note: This product is 510(k) cleared for OTC.

The AlcoCheck® Breath Alcohol Screen is a semi-quantitative test that approximates blood alcohol concentration (BAC) from exhaled breath.

  • 510(k) cleared for OTC (IVD over-the-counter record K093143)
  • Compact, plastic tube construction allows test to be carried anywhere
  • Pass/fail design detects alcohol at different threshold levels
  • Available in three threshold levels — .02, .05, .08

The AlcoCheck Breath Alcohol Screen offers users a simple, convenient method to detect alcohol use and to estimate levels of alcohol intoxication. The Breath Alcohol Screen provides semi-quantitative screening of the presence of alcohol, indicating relative blood alcohol concentration (BAC) at 0.02%, 0.05% and 0.08%.

AlcoCheck Breath Alcohol Screen color chart

Easy to use breath alcohol device available for over-the-counter use

To perform a test with the AlcoCheck Breath Alcohol Screen the user squeezes the tube to crush the ampoule and then blows into the end of the tube for 12 seconds.

Compare the color of the majority of crystals in the device to the color blocks on the label. The top two color blocks indicate a positive result at and above the device cutoff level. The bottom two color blocks — with the majority of crystals yellow, light yellow, or light green — indicate negative results.

Breath Alcohol Screen procedure

# 50902K, Box of 25
# 50905K, Box of 25
# 50908K, Box of 25

PDF iconAlcoCheck Breath Alcohol Screen Product Insert