Section 862.3050 - Breath-alcohol test system(a)Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9 .52 FR 16122, May 1, 1987, as amended at 84 FR 71797 , Dec. 30, 2019