(39 days)
The SYNCHRON Systems Alcohol (ALC) Reagent, when used in conjunction with SYNCHRON Systems Alcohol Calibrator, is intended for the quantitative determination of alcohol in human serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.
The SYNCHRON Systems Alcohol (ALC) Reagent in conjunction with SYNCHRON Systems Alcohol Calibrator, is intended for use on Beckman's SYNCHRON Systems Clinical Systems.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: SYNCHRON® Systems Alcohol (ALC) Reagent
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values for the SYNCHRON® Systems Alcohol (ALC) Reagent. Instead, it presents performance data (Method Comparison and Imprecision) and states that this data supports substantial equivalence to predicate devices already in commercial distribution. The implicit acceptance criteria are that the device performs comparably or better than the predicate device.
Given this, the table below reports the performance metrics directly from the study:
| Performance Metric | Acceptance Criteria (Implicit: Comparable to Predicate) | Reported Device Performance (SYNCHRON ALC Reagent) |
|---|---|---|
| Method Comparison (vs. DCL Ethanol Assay) | ||
| Slope | Close to 1.0 | 1.037 |
| Intercept (mg/dL) | Close to 0.0 | 0.34 |
| r (correlation coefficient) | Close to 1.0 | 0.9986 |
| Within-Run Imprecision (Default Range) | ||
| Level 1 (51.4 mg/dL): %C.V. | Low and acceptable for clinical use | 1.73% |
| Level 2 (102.2 mg/dL): %C.V. | Low and acceptable for clinical use | 1.53% |
| Level 3 (239.7 mg/dL): %C.V. | Low and acceptable for clinical use | 1.33% |
| Within-Run Imprecision (Extended Range) | ||
| Level 1 (287.55 mg/dL): %C.V. | Low and acceptable for clinical use | 1.24% |
| Level 2 (488.63 mg/dL): %C.V. | Low and acceptable for clinical use | 1.24% |
2. Sample Size Used for the Test Set and Data Provenance
-
Method Comparison Study:
- Sample Size: n = 78
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This type of study (comparing a new assay to a predicate) is typically prospective, but the document doesn't specify.
-
Imprecision Study:
- Sample Size (Default Range): n = 80 for each of the three levels (Level 1, Level 2, Level 3)
- Sample Size (Extended Range): n = 20 for each of the two levels (Level 1, Level 2)
- Data Provenance: Not explicitly stated. These are laboratory-based studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For the SYNCHRON® Systems Alcohol (ALC) Reagent, the "ground truth" for the method comparison study was established by the predicate method: DCL Ethanol Assay Kit on the SYNCHRON CX Systems. This is a comparative study against an existing, legally marketed device, not a study requiring human expert interpretation for ground truth. Therefore, there were no human experts used to establish ground truth in the traditional sense.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or adjudication for the test set. The comparison is between two quantitative analytical methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes the validation of a laboratory reagent for quantitative measurement of alcohol. MRMC studies are typically used for imaging or diagnostic algorithms that require interpretation by human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies presented are standalone performance evaluations of the SYNCHRON® Systems Alcohol (ALC) Reagent. The method comparison and imprecision studies assess the analytical performance of the reagent system itself, without human intervention in the result determination process beyond standard laboratory procedures for running the assay.
7. Type of Ground Truth Used
The ground truth for the method comparison study was the results obtained from the predicate method (DCL Ethanol Assay Kit). For the imprecision studies, the "ground truth" is the true concentration of alcohol in the control samples used, which is typically established by reference methods or gravimetric preparation.
8. Sample Size for the Training Set
Not applicable. This is an in vitro diagnostic (IVD) reagent, and the validation described involves analytical performance studies rather than machine learning model training. The reagent itself does not have a "training set" in the context of an AI/ML algorithm.
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 algorithm for this device.
§ 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.