(149 days)
This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
This devise is intended to measure alcohol in the human breathe. Measurements obtained by this device are use as an aid in the detection of alcohol intoxication.
Protocol's alcohol breath checker is designed to measure deep lung air to test for the presence of alcohol in the blood. Protocol's breath checker is an alcohol screening device and uses a blow time of at least 3 seconds to capture an accurate deep lung sample. Protocol's alcohol breathe tester contains an oxide semiconductor sensor designed to test for the presence of alcohol. The oxide semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.. The device provides a semi-quantitative measure of a patient's blood alcohol level using colored LEDs as indicators. The indications are: Red & Yellow: BAC 0.08 or more; Yellow: BAC 0.05 to 0.08; Green: BAC
The Protocol Alcohol Breath Checker is a breath-alcohol test system designed to measure alcohol in human breath for the diagnosis of alcohol intoxication.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to a predicate device (K052448, Connectables Pocket Breathalyzer) rather than explicitly stating acceptance criteria with specific numerical targets. However, based on the comparison provided and the ultimate conclusion, we can infer some key performance aspects being "accepted" as equivalent to the predicate.
| Feature | Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (Protocol Alcohol Breath Checker) |
|---|---|---|
| Accuracy | +/- 0.01% BAC | SAME (implied to be +/- 0.01% BAC) |
| Measurement Range | 0.00-0.40% BAC | SAME (0.00-0.40% BAC) |
| Blowing Time | 3 Seconds | 3 Seconds |
| Display Interpretation | Red: BAC > 0.08, Yellow: BAC 0.04 to 0.08, Green: BAC |
§ 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.