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510(k) Data Aggregation
(51 days)
DML
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.
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(69 days)
DML
The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in the quantitative analysis of ethyl alcohol in human serum or plasma.
The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in the quantitative analysis of ethyl alcohol in human urine, plasma, and serum. The Emit® II Plus Ethyl Alcohol Assay is designed for use with most clinical chemistry analyzers.
The Syva Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in quantitative analysis of ethyl alcohol in human urine, serum, or plasma.
Here's a breakdown of the acceptance criteria and the study details for the Emit® II Plus Ethyl Alcohol Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Study Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Comparative Analysis | Excellent correlation (high correlation coefficient, slope near 1) to predicate device. | Serum: Correlation of 0.986 with predicate method, slope of 1.000. |
| Urine: Correlation of 0.997 with predicate method, slope of 1.000. | ||
| Precision | Acceptable within-run and total precision (low %CV). | Within-run: %CV ranging from 1.39% to 1.55%. |
| Total precision: %CV ranging from 1.61% to 1.78%. | ||
| Specificity | Acceptable levels of cross-reactivity (low percentage). | Cross-reactivity ranging from |
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(35 days)
DML
ON•SITE Alcohol is recommended for professional use only and is not intended for overthe-counter sale to the general public. Professional use includes applications in healthcare, corrections and drug treatment.
ON•SITE Alcohol yields only a "qualitative" result. A positive result indicates that alcohol (ethanol) is present at a concentration of approximately 0.02% when performed according to the instructions.
Confirmation of ON•SITE Alcohol results using gas chromatography is recommended if quantitative results are desired.
ON•SITE Alcohol is a self contained, disposable enzymatic test device that provides rapid detection of alcohol in saliva or urine. It includes all reagents and supplies necessary to perform the test.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative form, but rather implied by the design intention and the performance characteristics observed in the 'modified' device compared to the 'current' device. The key goal was to increase the reaction time and slightly raise the limit of detection.
| Criteria (Implied) | Current Device Performance | Modified Device Performance | Target/Acceptance (Implied) |
|---|---|---|---|
| Accuracy & Precision (Detection at 0.008% w/v EtOH) | 13/20 positives in 2 mins, Mean Reaction Time: 111 sec | 0/20 positives in 2 mins, Mean Reaction Time: 147 sec | Reduced detection at 0.008% (i.e., fewer positives at 2 mins, increased reaction time) |
| Accuracy & Precision (Detection at 0.02% w/v EtOH) | 20/20 positives in 2 mins, Mean Reaction Time: 81 sec | 12/20 positives in 2 mins, Mean Reaction Time: 115 sec | Maintain detection at 0.02% (or slightly reduced as a side effect of shifted LOD), increased reaction time |
| Accuracy & Precision (Detection at 0.032% w/v EtOH) | 20/20 positives in 2 mins, Mean Reaction Time: 61 sec | 20/20 positives in 2 mins, Mean Reaction Time: 100 sec | Maintain detection at 0.032%, increased reaction time |
| Sensitivity (Reaction Times across various EtOH concentrations) | Range of mean reaction times from 1 min 6 sec to 1 min 47 sec | Range of mean reaction times from 1 min 29 sec to 2 min 41 sec | Consistently increased reaction times across all tested concentrations |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Accuracy and Precision: 20 replicates for each of the three ethanol controls (0.008%, 0.02%, 0.032% w/v). This means 20x3 = 60 tests for the current device and 60 tests for the modified device, totaling 120 tests for this part.
- Sensitivity: 10 replicates for each of the eight ethanol controls (0.005% to 0.0225% w/v). This means 10x8 = 80 tests for the current device and 80 tests for the modified device, totaling 160 tests for this part.
- Data Provenance: Not specified within the document (e.g., country of origin, type of samples used - saliva/urine). Given the context of a 510(k) summary, it's implied to be laboratory testing of controlled ethanol solutions, not human samples. It is a prospective laboratory study comparing a modified device to its predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth was established by laboratory-prepared ethanol solutions of known concentrations. The "results were read" likely implies visual interpretation by a technician, but their number or qualifications are not specified as it's not an expert-driven ground truth.
4. Adjudication Method for the Test Set
Not applicable. The outcomes were objective measurements (time to positive result) and counts of positive/negative results at a specific time point, based on predefined ethanol concentrations. No adjudication process for differing interpretations of subjective data would be needed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This study is a technical performance comparison between two versions of a diagnostic device in a laboratory setting, not a study involving human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was a standalone performance study. The device's reaction to known concentrations of alcohol was evaluated directly, without human interpretation of results beyond simple visual observation of a color change, and timing that change. There is no "algorithm" in the modern sense relevant to AI.
7. The Type of Ground Truth Used
The ground truth used was objectively known concentrations of ethanol in laboratory-prepared control solutions.
8. The Sample Size for the Training Set
Not applicable. This device is an enzymatic test, not an AI/machine learning model, so there is no training set in the computational sense. The "training" for the device's development would have been implicit in chemical formulation and calibration, not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of an AI/ML model. If interpreted very broadly as the development process for the chemical formulation, the ground truth would still be based on known chemical reactions and desired performance characteristics to achieve the intended "shift in reaction time and detection levels."
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