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The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.

The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.

This test provides only preliminary test results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method.

A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.

The Triage TOX Drug Screen Methadone assay is a fluorescence immunoassay intended to be used with the Triage MeterPlus for the point-of-care qualitative determination of methadone in urine.

The Triage Methadone assay is identical in principle, reagents and procedure to the previously cleared Triage TOX Drug Screen (FDA file number K043242). The only difference between the two tests is that an assay for methadone has been added.

Here's a breakdown of the acceptance criteria and study information for the Triage® TOX Drug Screen Methadone assay, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document focuses on the substantial equivalence of the new Methadone assay to a previously cleared device. The primary performance metric presented is the overall agreement with the predicate device and the confirmation by GC/MS for discordant samples.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 102 specimens
• Data Provenance: Obtained from clinical sources (retrospective, collected from patients for whom testing was clinically indicated). The country of origin is not specified, but the submission is to the FDA in the US, suggesting the data is likely from the US.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the number of experts used to establish the ground truth or their qualifications.
• The primary ground truth for discordant samples was established using Gas Chromatography/Mass Spectroscopy (GC/MS), which is an analytical chemical method and not a human expert consensus.

4. Adjudication Method

• Not applicable / None specified for clinical samples. The comparison relies on the Triage 8 Panel for Drugs of Abuse as a predicate and GC/MS for discrepancy resolution. There's no indication of multiple human readers adjudicating results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC study was not done. This device is an in vitro diagnostic (IVD) assay designed for qualitative determination of substances, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, the concept of improving human readers with AI assistance does not apply in this context.

6. Standalone (Algorithm Only) Performance Study

• Yes, in effect. The study described is a direct comparison of the Triage Methadone assay ("algorithm only") against a predicate device and GC/MS. The device's performance (96.1% overall agreement, 100% agreement with GC/MS for specific enantiomers) is a standalone performance metric. The "Triage MeterPlus" performs the fluorescence immunoassay without human interpretation of the raw signal.

7. Type of Ground Truth Used

• Predicate Device/Clinical Samples and GC/MS Confirmation: For the initial comparison, the "ground truth" was established by the predicate device (Biosite Triage® 8 Panel for Drugs of Abuse). For the discordant samples between the Triage Methadone assay and the predicate, the definitive ground truth was established by GC/MS (Gas Chromatography/Mass Spectroscopy), an objective analytical gold standard for drug confirmation. Specifically, it determined the presence of l-methadone at concentrations greater than 175 ng/mL.

8. Sample Size for the Training Set

• The document does not explicitly mention a training set sample size. This type of IVD device is typically developed and optimized during its creation phase, and the comparison study is a validation of the finalized assay. The "training" would be part of the R&D process, not typically a separate, reported clinical training set like in AI/ML models.

9. How the Ground Truth for the Training Set Was Established

• Not explicitly stated/not applicable in the context of a "training set" as understood in AI/ML. For immunoassay development, ground truth for optimization and calibration would typically be established using known concentrations of analytes (e.g., methadone standards) prepared in a suitable matrix (e.g., synthetic urine or stripped urine), often confirmed by methods like GC/MS. The document focuses on the validation against clinical samples and a well-established reference method.

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