(127 days)
The Contralco Alcohol Breath Tester is an in vitro medical device to semi-quantitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available at several detection cut-offs: 0.02, 0.04, 0.05, 0.06, 0.08, and 0.10 relative percent Blood Alcohol Concentration (BAC). 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 Contralco Alcohol Breath Tester is a visual qualitative test for alcohol in human breath. The Tester contains chemicals that change color in the presence of alcohol vapors. The Tester is made up of 2 parts: the reagent and the plastic bag. One part contains light yellow crystals that change color when exposed to alcohol vapors. The other part (plastic bag) collects the volume of air necessary for the analysis. If alcohol is present, the crystals will change from yellow to light green. The number of crystals that change color will depend on the cut-off of the Tester and the amount of alcohol in the breath. The yellow crystals in the reagent are coated with Chromium VI oxide (CrO3) and sulfuric acid (H2SO4). The amount of these indicator chemicals is adjusted according to the selected cut-off of the tester. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium sulfate [Cr2(SO4)3]. The majority of crystals change from yellow to light green when alcohol vapors are present at a level equal to or exceeding the cut-off of the Tester. The Contralco Tester is available in several cut-offs (0.02, 0.04, 0.05, 0.06, 0.08 and 0.10%). The cut-off is printed on the Tester label and is expressed as a specific percentage of breath alcohol.
The Contralco Alcohol Breath Tester is an in vitro medical device designed to semi-quantitatively detect alcohol in human breath. The device is a disposable screening tool for one-time use, available in several cut-offs: 0.02, 0.04, 0.05, 0.06, 0.08, and 0.10 relative percent Blood Alcohol Concentration (BAC). It is intended for over-the-counter use as a screening device to indicate the possible presence of alcohol in the blood.
A study was conducted to assess the safety and effectiveness of the Contralco Alcohol Breath Tester by comparing its performance against a quantitative comparator device (LION, manufactured by LION LABORATORIES LIMITED) and to confirm that consumers could correctly perform and interpret the test according to the package insert.
1. Acceptance Criteria and Reported Device Performance:
The document implicitly defines the acceptance criteria as the device results being "coherent" with the quantitative comparator device, with a specified effectiveness percentage. No explicit qualitative criteria for "coherent" are provided beyond the single reported disagreement.
| Acceptance Criteria (Implicit) | Reported Device Performance (Contralco 0.05% Cut-off) |
|---|---|
| Results are coherent with a quantitative comparator device (LION). | 58 out of 59 measurements were coherent with the quantitative device. One measurement was not coherent. This resulted in a reported 98% effectiveness. |
2. Sample Size and Data Provenance:
- Test Set Sample Size: 59 measures/volunteers.
- Data Provenance: The study was conducted at the exit of a nightclub. The country of origin is not explicitly stated, but the submitter is from France. The study appears to be prospective, involving volunteers in a real-world setting.
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: One trained individual operated the quantitative comparator device (LION).
- Qualifications of Experts: The individual operating the quantitative device is described as "trained." Further specific qualifications (e.g., years of experience, certification) are not provided.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The study design involved a direct comparison between the subject device (interpreted by volunteers) and a quantitative comparator device (operated by a trained individual) as the ground truth. There was no mention of multiple reviewers adjudicating the results of the Contralco device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No. This study does not appear to be an MRMC study. It focused on the Contralco device's performance as interpreted by consumers versus a quantitative reference, rather than comparing human reader performance with and without AI assistance.
6. Standalone Performance:
- Standalone Performance: Yes, the study essentially tested the standalone performance of the Contralco Alcohol Breath Tester as interpreted by users. The "volunteers blew in balloons, and interpreted the results of the reactant." This represents the device's performance without a human expert interpreting its immediate output. The comparison data from the LION device served as the reference.
7. Type of Ground Truth Used:
- Ground Truth: Quantitative measurements from a LION Alcohol Breath Tester, operated by a trained individual. This serves as a reference standard for Blood Alcohol Concentration (BAC).
8. Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This device is a chemical-based test kit and does not involve AI or machine learning models that require a training set. The calibration of the device with different cut-offs (e.g., 0.05% BAC) is an intrinsic property of its chemical composition, adjusted according to the desired detection cut-off.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable. As noted above, there is no training set for this device. The "training" of the device is its manufacturing process where the amount of indicator chemicals (Chromium VI oxide and sulfuric acid) is adjusted to produce a color change at specific cut-off levels.
§ 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.