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510(k) Data Aggregation
(69 days)
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 <0.1% to 14.2% for potentially cross-reacting compounds. |
| Sensitivity | Ability to distinguish low concentrations from zero. | Less than 3.0 mg/dL (lowest concentration of amphetamines that can be distinguished from 0 ng/mL with 95% confidence – Note: The text explicitly mentions "amphetamines" here, which seems like a typo given the Ethyl Alcohol assay. Assuming it means ethyl alcohol, the principle holds.) |
| Endogenous Interference | High recovery compared to controls (minimal interference). | Serum: Bilirubin: 99% recovery, Hemoglobin: 100% recovery, Triglycerides: 97% recovery. LDH/Lactate: 0.4 mg/dL interference (not significant). |
| Urine: Recoveries for interfering substances ranging from 99% to 104%. | ||
| Spiked Sample Recovery | Recovery within an acceptable range (e.g., 90-110%). | Recovery of ethanol spikes in human serum and urine ranged between 95.7% and 101.5% across a quantitative range of 10 to 600 mg/dL. |
| High Sample Dilution | Recovery within an acceptable range after dilution. | Recovery from normal concentrations in diluted serum and urine (with water or Negative Calibrator) ranged from 97.1% to 100.9%. |
| Anticoagulants | Average recovery compared to serum control within an acceptable range. | Average recovery versus serum control ranged from 95.5% to 102.3% for EDTA (K3), Sodium Citrate, Sodium Heparin, and Oxalate/Fluoride. |
| Linearity | Considered linear according to CAP linearity survey acceptance criteria. | Both serum and urine samples are considered linear according to the acceptance criteria of the CAP linearity survey. |
| Urine Preservatives | Recoveries compared to controls within an acceptable range. | Recoveries of urine preservatives compared to controls ranged from 97.5% to 99.1%. |
| Calibration Stability | Acceptable duration of calibration stability. | 25 days on the SYVA-30R Biochemical System. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for most of the individual tests. It mentions "human serum or plasma" and "human urine, serum, or plasma" as the sample types.
- Provenance: The document does not specify the country of origin of the data. It is generally implied to be from the United States given the FDA submission.
- Retrospective/Prospective: The document does not specify whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The studies performed are laboratory-based analytical performance studies, not clinical studies requiring expert interpretation of results for ground truth establishment in the traditional sense. The ground truth for these types of assays is established through reference methods or known concentrations, not expert consensus.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies are analytical performance assessments of an in vitro diagnostic device, not studies involving human interpretation or adjudication of cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic tools where human readers interpret results, often with and without AI assistance. The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay, which is an automated chemical analysis, not subject to human reader interpretation in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are essentially standalone performance studies for the Emit® II Plus Ethyl Alcohol Assay. The device operates as an algorithm/assay without human intervention in the interpretation of the assay result itself. Its performance is measured directly against established analytical metrics and a predicate device.
7. The Type of Ground Truth Used:
The ground truth for these analytical studies is primarily established through:
- Reference Methods/Predicate Device: For comparative analysis, the predicate device (Emit® Ethyl Alcohol Assay K903153) served as the reference standard.
- Known Concentrations/Spiked Samples: For precision, sensitivity, spiked sample recovery, endogenous interference, high sample dilution, anticoagulant, and urine preservative studies, the ground truth would be the known concentrations or expected values of ethyl alcohol or interferents.
- CAP Linearity Survey Acceptance Criteria: For linearity, the ground truth/standard is defined by these external criteria.
8. The Sample Size for the Training Set:
This information is not applicable/not provided. The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay, which is a chemical reaction-based method, not a machine learning or AI algorithm that requires a "training set" in the computational sense. Its parameters are chemically and biochemically defined, not iteratively learned from data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As stated above, this device does not utilize a training set in the way an AI/ML algorithm would. The "ground truth" equivalent for developing such an assay would involve established biochemical principles, reagent formulations, optimization experiments, and quality control standards.
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