(80 days)
The SYNCHRON Systems Methaqualone Reagent, in conjunction with the SYNCHRON System DAT Urine Calibrators, is intended for use in the qualitative determination of Methaqualone in human urine samples. This assay is designed for use with the family of SYNCHRON Systems, which include analyzers such as the SYNCHRON CX®4, CX6 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
The SYNCHRON Methaqualone Reagent is an enzyme immunoassay reagent test kit for the SYNCHRON Systems and provides a rapid screening procedure for determining the presence of Methaqualone and it's metabolites in urine. It is designed to complement the current panel of CX Drugs of Abuse Assays, previously cleared by FDA. The kit consists of reagent and calibrators.
This document describes the performance of the SYNCHRON Systems Methaqualone Reagent, an enzyme immunoassay for the qualitative determination of Methaqualone in human urine.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct targets in the provided text. However, the study aims to demonstrate substantial equivalence to the predicate device (Emit II Methaqualone Assay) and highlights specific performance metrics. Below is a table summarizing the reported device performance, which implicitly serves as the 'met' acceptance criteria given the submission of the summary of safety and effectiveness.
| Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Overall Agreement | High agreement with predicate device (Emit II) | 94% |
| Relative Sensitivity | High sensitivity compared to predicate device (Emit II) | 88% |
| Relative Specificity | High specificity compared to predicate device (Emit II) | 100% |
| Shelf-life (unopened) | Comparable to predicate or established standard | 12 months |
| On-Instrument Stability | Comparable to predicate or established standard | 60 days |
| Calibration Frequency | Comparable to predicate or established standard | 7 days |
| Within-Run Imprecision (Negative Calibrator) | Low %CV | 0.6% |
| Within-Run Imprecision (Control 1: 200 ng/mL) | Low %CV | 0.5% |
| Within-Run Imprecision (Low Calibrator: 300 ng/mL) | Low %CV | 0.4% |
| Within-Run Imprecision (Control 2: 375 ng/mL) | Low %CV | 0.4% |
| Within-Run Imprecision (High Calibrator: 1000 ng/mL) | Low %CV | 0.3% |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 103 samples.
- Data Provenance: Not explicitly stated, but the study compares the SYNCHRON Methaqualone Reagent to the Emit II Reagent and also mentions a comparison with GCMS. The nature of the samples (e.g., patient samples, spiked samples) and their geographical origin (e.g., country) are not specified. It is likely retrospective as it involves comparison to existing methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The document does not mention the use of human experts or readers to establish the ground truth for the test set.
- The ground truth reference methods mentioned are the Emit II Reagent (a predicate device) and GCMS (Gas Chromatography-Mass Spectrometry).
4. Adjudication Method for the Test Set
- No human adjudication method is described, as the ground truth was established by laboratory methods (Emit II and GCMS).
- The study implicitly uses the Emit II Reagent as a primary comparitor, and GCMS as a confirmatory method for discordant results (as indicated by "Number of Disconcordant w/ GCMS: 0").
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
- This device is an automated laboratory assay (enzyme immunoassay) for drug detection, not an AI-assisted diagnostic imaging or classification tool that would involve human readers. Therefore, the concept of human reader improvement with/without AI assistance does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, the performance metrics reported (Overall Agreement, Relative Sensitivity, Relative Specificity, Imprecision, Stability) are indicative of standalone performance of the SYNCHRON Systems Methaqualone Reagent as an algorithm/assay.
- The device is an automated chemical analyzer component, and its reported performance reflects its intrinsic capability without direct human intervention in the result interpretation after the sample is processed by the instrument.
7. The Type of Ground Truth Used
- The primary ground truth for comparison in the "Relative Sensitivity and Specificity Study Results" was the Emit II Methaqualone Reagent (a predicate enzyme immunoassay).
- For discordant results, a more definitive analytical method, GCMS (Gas Chromatography-Mass Spectrometry), was used as a confirmatory ground truth. The fact that there were "0" discordant results with GCMS suggests GCMS was considered the gold standard for verifying the true status of the "disconcordant" samples when compared to Emit II.
8. The Sample Size for the Training Set
- The document does not mention a "training set" or "training data." This is because the device is a chemical reagent and assay system, not a machine learning model that requires a training phase.
- The described studies are performance validation studies for a diagnostic assay.
9. How the Ground Truth for the Training Set was Established
- As there is no mention of a training set, the establishment of ground truth for a training set is not applicable to this device.
§ 862.3630 Methaqualone test system.
(a)
Identification. A methaqualone test system is a device intended to measure methaqualone, a hypnotic and sedative drug, in urine. Measurements obtained by this device are used in the diagnosis and treatment of methaqualone use or overdose.(b)
Classification. Class II (special controls). A methaqualone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).