(140 days)
The ALCO-SCREEN® 02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative Blood Alcohol Concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in vitro diagnostic use. The assay is a disposable test for one-time use.
ALCO-SCREEN® 02 is a visually read qualitative test for the detection of alcohol using saliva. The test strip indicates the relative Blood Alcohol Concentration (BAC) at 0.02%. The device consists of a box of 24 individually packaged single test strips each designed for single use and to be disposable, and instruction for use.
Here's an analysis of the provided text regarding the Alco-Screen® 02 device's acceptance criteria and studies:
Acceptance Criteria and Device Performance
The provided text does not explicitly state quantitative acceptance criteria in a table format with specific metrics. However, it does indicate the device's intended performance.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Detection of ethyl alcohol in human saliva | Qualitatively detects ethyl alcohol in human saliva |
| Detects relative Blood Alcohol Concentrations (BAC) ≥ 0.02% | Detects relative BAC ≥ 0.02% |
| Performs as intended | "Results demonstrate that Alco-Screen® performs as intended and meets all established specifications." |
| Substantially equivalent to predicate device (Orasure Technologies Inc, QED A150 Saliva Alcohol Test) | "Alco-Screen® 02 is substantially equivalent to the predicate device currently marketed under the Food, Drug and Cosmetic Act." |
Study Details
Based on the provided information, the description of the studies is quite limited.
- Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "field use studies with an evidentiary device" but does not provide details on sample size, country of origin, or whether the study was retrospective or prospective.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The device is a visually read qualitative test, not an AI-assisted diagnostic. There is no mention of human readers' performance improvement with or without AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a standalone test strip for visual interpretation. There is no algorithm involved in its direct interpretation; a human visually reads the color change.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated how the "true" BAC levels were determined for the performance tests. Given the nature of a BAC test, it's highly probable that a referencemethod (e.g., blood alcohol analysis or a calibrated breathalyzer) would be used as the ground truth.
- The sample size for the training set: Not applicable. This device is a chemical test strip, not an AI algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.
Summary of "Performance Testing" Section:
The document states:
"The performance characteristics of Alco-Screen® 02 were determined by conducting precision and reproducibility studies, analytical specificity studies, stability studies, and field use studies with an evidentiary device. Results demonstrate that Alco-Screen® performs as intended and meets all established specifications."
This paragraph briefly outlines the types of studies conducted but provides no quantitative results, sample sizes, methodology details, or specifics about the "evidentiary device" used in field studies. The "established specifications" are not detailed in the provided text.
§ 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.