(158 days)
The Teco Saliva Alcohol Test is a semi-quantitative screening test for measuring alcohol in human saliva. This strip specifies the relative Blood Alcohol Concentration (BAC) at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results can be used for the indication of alcohol intoxication. For in vitro diagnostic use only.
The Teco Saliva Alcohol Test is a screening test for the semi-quantitative detection of the presence of ethyl alcohol in human saliva. The test strip indicates relative Blood Alcohol Concentrations (BAC) at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results are used for the diagnosis of alcohol intoxication. The test is intended for both prescription and over-the-counter in vitro diagnostic use. The assay is a disposable test for one-time use.
The Teco Saliva Alcohol Test is used to detect the amount of alcohol in the saliva after consumption. This is a semi-quantitative test that is read visually. The test strip determines the relative Blood Alcohol Concentration at 5 cut-off levels (negative, 0.02%, 0.04%, 0.08% and 0.3%). The device consists of a test strip (1 test strip per foil pouch). The resultant color on the test strip is compared to the color blocks printed on the pouch.
The Teco Saliva Alcohol Test is a plastic strip tipped with a reactive pad containing tetramethylbenzidine, alcohol oxidase, and peroxidase. The test is utilizes two coupled enzymatic reactions to create the visual changes in the presence of varying amounts of saliva alcohol. The first reaction consists of an oxidation reaction where the ethanol in the saliva is converted to aldehyde by the alcohol oxidase. The second reaction is the oxidation of TMB, the color indicator substrate, and is catalyzed by the enzyme peroxidase. The color change of the pad corresponds to the amount of present alcohol in the sample. The results are read by comparing the colored pad to the color chart found on the strip package
This document describes the Teco Saliva Alcohol Test, a semi-quantitative screening test for measuring alcohol in human saliva. The device aims to determine relative Blood Alcohol Concentration (BAC) at specific cut-off levels.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format for performance metrics like sensitivity, specificity, or accuracy. It primarily focuses on demonstrating substantial equivalence to a predicate device (ACON Mission Saliva Alcohol Test).
However, it implicitly indicates that the device's performance is acceptable if it can achieve "comparable testing data" to the predicate device and "perform satisfactorily" in conjunction with various studies.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | Comparable testing data to the legally marketable ACON Mission Saliva Alcohol Test. Performance is satisfactory when used appropriately. | Clinical study results indicate that intended users were able to obtain comparable testing data when using the Teco Saliva Alcohol Test and the ACON Mission Saliva Alcohol test. Performance characteristics were verified through method comparison, precision, linearity, shelf life, and stress studies. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Clinical study results indicate that the intended users were able to obtain comparable testing data." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the clinical study.
3. Number of Experts and Qualifications for Ground Truth Establishment
The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications. The primary ground truth for comparison appears to be the results obtained from the predicate device.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. It mentions comparison with a predicate device, suggesting a direct comparison rather than an expert consensus/adjudication process for the Teco Saliva Alcohol Test's results themselves.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The evaluation focuses on the device's performance compared to a predicate, not on how human readers' performance improves with or without the device's assistance.
6. Standalone (Algorithm Only) Performance Study
The Teco Saliva Alcohol Test is described as a "visually read color change" device with the resultant color compared to color blocks printed on the pouch. This intrinsically involves human interpretation. Therefore, a standalone (algorithm only without human-in-the-loop performance) study is not applicable and not mentioned.
7. Type of Ground Truth Used
The primary "ground truth" used for evaluating the Teco Saliva Alcohol Test is the performance of a legally marketed predicate device (ACON Mission Saliva Alcohol Test). The clinical study aimed to show "comparable testing data" between the two devices. The predicate device itself would have had its own established ground truth (likely laboratory confirmation of BAC levels).
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This device is a chromogenic assay; it is not a machine learning or AI-based algorithm that typically requires explicit training datasets.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of this device, the question of how its ground truth was established is not applicable.
§ 862.3040 Alcohol test system.
(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.