(252 days)
The Alco Tube Plus Alcohol Detector is an in vitro medical device to qualitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available in two cut-offs including 0.05 and 0.08 percent breath alcohol. The device is used only as a screening device and is only an indication of the possible presence of alcohol in the blood of the test subject.
The Alco Tube Plus Alcohol Detector (Tester) is a visual qualitative test for the presence of alcohol in human breath. The tester is constituted of glass tubing containing a reagent of yellow crystals that change color when exposed to alcohol vapors. The other part is an opening to blow into while running the test. If alcohol is present, the crystals will change from yellow to green. How many crystals turn color will depend on the cut-off of the Tester and how much alcohol is in the breath. The yellow crystals are coated with Potassium dichromate and sulfuric acid. The amount of these indicator chemicals is adjusted according to the selected cutoff of the Tester. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium sulfate. The majority of crystals change from yellow to green when alcohol vapors are present at a level equal to or exceeding the cutoff of the Tester. The Alco Tube Plus is available in two cut-offs (0.05%) The cut-off is printed in the instructions and is expressed as a specific percentage of breath alcohol
Here's a breakdown of the acceptance criteria and the study details for the Alco Tube Plus Alcohol Detector, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state "acceptance criteria" in terms of specific performance metrics that the device must meet (e.g., minimum sensitivity, specificity, or accuracy thresholds). Instead, the study's aim was a "Comparison to Evidentiary Breath Test (Alco-Sensor IV)" and to demonstrate that the device is "as safe and effective as the predicate device." The tables provided show the device's performance against different quantitative breath alcohol levels.
Therefore, the "acceptance criteria" can be inferred as the device demonstrating reliable qualitative detection of alcohol at its specified cut-offs (0.05% and 0.08%) when compared to an evidentiary breath test, with no false positives below these cut-offs and clear positive indications at or above them.
| Metric / Performance Aspect | Acceptance Criteria (Inferred) | Reported Device Performance (0.05% cut-off) | Reported Device Performance (0.08% cut-off) |
|---|---|---|---|
| Qualitative Detection at Cut-off | The device should correctly indicate "positive" when breath alcohol levels are at or above the stated cut-off, and "negative" when below. Specifically, no false positives for levels clearly below the cut-off, and consistent positives for levels clearly above. | Positive Results: |
- Near cutoff positive (> 0.05 - 0.083%): 70
- Greater than cutoff + 60% (> 0.083%): 21
Negative Results: - Less than cutoff - 60% (0.05 – 0.083%): 70
- Greater than cutoff + 60% (> 0.083%): 21
Negative Results: - Less than cutoff – 60% (
§ 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.