(51 days)
The Ethanol assay is used for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine. The Ethanol assay should be exclusively used to detect ethanol and not other alcohols such as isopropanol or methanol. Reactivity with compounds structurally unrelated to ethanol has not been observed.
Ethanol is an in vitro diagnostic assay for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine. The assay is based on an enzymatic reaction. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically. The increase in absorbance at 340 nm is proportional to the concentration of alcohol in the specimen.
This submission describes the "Ethanol" assay, an in vitro diagnostic device for the quantitative analysis of ethyl alcohol in human serum, plasma, or urine. The study presented aims to demonstrate substantial equivalence to a predicate device, the Emit® II Plus Ethyl Alcohol assay (K993980).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Performance) | Reported Device Performance (Ethanol Assay) |
|---|---|
| Correlation with Predicate Device (Emit® II Plus Ethyl Alcohol assay on SYVA 30R Analyzer) | Acceptable correlation demonstrated. |
| - Serum: Not explicitly stated as a numerical criterion, but the predicate's performance implies a high correlation is expected. | - Serum: Correlation coefficient = 0.996, slope = 1.00, Y-intercept = -1.87 mg/dL |
| - Urine: Not explicitly stated as a numerical criterion, but the predicate's performance implies a high correlation is expected. | - Urine: Correlation coefficient = 0.997, slope = 1.01, Y-intercept = -4.85 mg/dL |
| Precision (Implied from predicate or general assay expectations) | Precision studies conducted. |
| - Within-run Total %CV: Implied to be low for similar assays. | - Low control: 5.1% Total %CV |
| - Within-run Total %CV: Implied to be low for similar assays (e.g., around 1-5% for calibrators/controls). | - 100 mg/dL calibrator/control: 2.8% Total %CV |
| - Within-run Total %CV: Implied to be low for similar assays. | - High control: 1.7% Total %CV |
| Assay Range (Implied from predicate or general assay expectations) | 10 to 600 mg/dL |
| Limit of Quantitation (Sensitivity) (Implied from predicate or general assay expectations) | 5 mg/dL |
Note: The acceptance criteria are not explicitly defined as pass/fail thresholds in the provided text but are inferred from the need to demonstrate "substantially equivalent performance" to the predicate device. The presented performance characteristics are typical metrics for demonstrating equivalence in IVD assays.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of human serum or urine samples used in the comparative performance studies to generate the correlation data (correlation coefficients, slopes, and y-intercepts). It only mentions "Comparative performance studies were conducted." The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.
For the precision studies, "three levels of control material" were used for the within-run study. The number of replicates for each level is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "Ethanol" assay is an in vitro diagnostic (IVD) test that quantifies a biomarker (ethyl alcohol concentration). The "ground truth" for such devices is typically established by comparing its performance to a reference method or another legally marketed device (the predicate device in this case), or by using known concentrations in control materials. It does not involve interpretation by human clinicians or experts for ground truth establishment in the same way an imaging or pathology device might require.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (e.g., 2+1, 3+1) is not applicable here. Adjudication is used to resolve discrepancies in independent interpretations by multiple experts, typically for qualitative or semi-quantitative diagnostic tests where human judgment is involved. For a quantitative IVD assay like the Ethanol assay, the comparison is directly between the numerical results of the new device and the predicate device (or known concentrations).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. MRMC studies are used to evaluate the impact of an AI-powered diagnostic aid on human reader performance (e.g., radiologists interpreting images). The "Ethanol" assay is an automated in vitro diagnostic test for quantifying a biomarker and does not involve human interpretation in the diagnostic process beyond performing the test and reviewing results. Therefore, there is no "human reader improvement with AI vs without AI assistance" to measure.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The entire study presented is a standalone performance evaluation of the "Ethanol" assay. The device itself is an automated enzymatic assay. The performance characteristics (correlation, precision, range, sensitivity) are inherently "standalone" in that they describe the capability of the device itself to accurately measure ethanol concentration, without requiring active human interpretation of its diagnostic output (beyond standard laboratory procedures).
7. The Type of Ground Truth Used
The ground truth used for the comparative performance studies was the results obtained from the predicate device, the Emit® II Plus Ethyl Alcohol assay on the SYVA 30R Analyzer. For the precision studies, the ground truth was the known concentrations of the control materials (low control, 100 mg/dL calibrator/control, and high control).
8. The Sample Size for the Training Set
The document does not specify a training set sample size. This submission describes an in vitro diagnostic that uses an enzymatic reaction. This type of assay does not typically involve machine learning algorithms that require "training sets" in the conventional sense (i.e., large datasets used to train a model). Instead, it relies on established biochemical principles and calibration procedures.
9. How the Ground Truth for the Training Set Was Established
As noted above, this device does not utilize a training set in the machine learning context. The "ground truth" relevant to the development and calibration of such an enzymatic assay would historically involve:
- Known concentrations of analyte: Prepared standards and calibrators with precisely measured ethanol concentrations.
- Reference methods: Historical or established reference methods for measuring ethanol.
These elements would be used during the assay's development and manufacturing to establish its analytical performance characteristics and ensure it accurately measures ethanol. The specific details of how these were established are not provided in this 510(k) summary, as it is focused on demonstrating equivalence to the predicate, not the de novo development process.
§ 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.