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The Quidel Triage® TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine of up to 9 drug assays at or above the threshold concentrations. The threshold concentrations are provided below:

This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (GC/MS), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods.

The Quidel Triage® TOX Drug Screen, 94600 is a single use test device and is used in conjunction with the Quidel Triage® MeterPro. The device contains murine monoclonal antibody conjugates and drug conjugates labeled with a fluorescent dye or immobilized on the solid phase and stabilizers. The testing device is inserted into and read by the Quidel Triage® MeterPro. Threshold concentrations are used to separate a negative result from a presumptive positive result.

This FDA 510(k) summary describes modifications to an existing device, and therefore, many of the standard performance characteristics were "Not applicable" as they were assessed in the original submission (K182719). The primary assessment here is for analytical specificity for four additional compounds.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for the analytical specificity in this submission aren't explicitly stated as numerical targets in the same way clinical performance metrics would be. Instead, the study's purpose was to demonstrate cross-reactivity for the additional compounds. The "reported device performance" is the measured cross-reactivity percentage.

Note on Acceptance Criteria: For analytical specificity (cross-reactivity), the "acceptance" is typically that the manufacturer characterizes the cross-reactivity of relevant compounds. There isn't usually a strict numerical threshold for what percentage is "acceptable" as it depends on the clinical context and the compound. The goal is to inform users of potential interferences. In this case, the acceptance is implied by the FDA's clearance, indicating that the characterized cross-reactivity does not negatively impact substantial equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the specific number of test samples (e.g., individual spiked urine samples) used for each cross-reactivity compound. It only lists the compounds and their cross-reactivity percentages.
• Data Provenance: Not specified in this document. Assumed to be experimental data generated by the manufacturer (Quidel Cardiovascular Inc.) in a lab setting. The country of origin is not mentioned, and it is a prospective lab study to characterize the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable for this type of analytical specificity study. The ground truth (the presence and concentration of the spiked compounds) is established by the controlled experimental setup and precise chemical preparation, not by expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is an analytical study, not one requiring expert adjudication of clinical or imaging data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a qualitative in vitro diagnostic assay, not an imaging or interpretive AI device that would typically involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone performance study was implicitly done in the sense that the device (Quidel Triage® TOX Drug Screen, 94600 with the Triage® MeterPro) determines the presence of drugs based on its internal algorithms (competitive immunoassay followed by fluorescence detection and threshold comparison). The reported cross-reactivity percentages are a measure of its standalone analytical performance. No "human-in-the-loop" is involved in the determination of a positive/negative result by the MeterPro.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this analytical specificity study was analytical spiking and known concentration. The compounds were experimentally prepared at known concentrations in a matrix (likely drug-free human urine) and then tested with the device. The "Results Positive at (ng/mL)" column indicates the lowest concentration at which the device reported a positive result for that compound.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would require a "training set" in the traditional sense of computational models. The device's underlying immunoassay technology relies on specific antibody-antigen binding, not trained algorithms.

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

Not applicable, as there is no "training set" for this immunoassay device.

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