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The DRI® Hydrocodone Assay is intended for the qualitative and semi-quantitative detection and estimation of Hydrocodone and its metabolites in human urine at a cutoff of 300 ng/mL. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of specimen for confirmatory method such as LC-MS/MS or GC-MS and permitting laboratories to establish quality control measures.

This assay provides a preliminary analytical test result. A more specific alternative chemical method must be used in order to confirm an analytical result. Gas chromatography/mass spectrometry (GC/MS) and Liquid Chromatography/ tandem mass spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The DRI® Hydrocodone Assay Calibrators are intended for the DRI® Hydrocodone Assay. For In Vitro Diagnostic Use Only.

The DRI® Hydrocodone Controls are unassayed quality control material intended for use in the DRI Hydrocodone Assay to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. For In Vitro Diagnostics Use Only

The DRI® Hydrocodone Assay is supplied as a liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect Hydrocodone and its metabolites without any significant cross-reactivity to other opiate compounds. The assay is based on competition between a drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) and free drug from the urine sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specific antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. In the presence of free drug, the free drug occupies the antibody binding sites, allowing the drug bound G6PDH to interact with the substrate, resulting in enzyme activity. This phenomenon creates a direct relationship between the drug concentration in urine and enzyme activity. The enzyme activity is determined spectrophotometrically at 340 nm by measuring the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.

The DRI® Hydrocodone Assay is a kit comprised of two reagents, Reagent A and Reagent E, which are bottled separately but sold together within the same kit.

The Reagent A solution contains: mouse monoclonal anti-hydrocodone antibody, glucose-6phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide (≤0.09%) as a preservative). The Reagent E solution contains: glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide (≤0.09%) as preservative.

The DRI® Hydrocodone Enzyme Immunoassay calibrators designated for use at the 300 ng/mL cutoff contain 0 (negative), 100, 300, 500, and 1,000 ng/mL of hydrocodone in human urine matrix with sodium azide (≤0.09%) as preservative. The controls are provided at a concentration of 225 and 375 ng/mL. The calibrators are sold separately and the two controls are sold as a kit.

Here's a breakdown of the acceptance criteria and study information for the DRI® Hydrocodone Assay, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision Studies: 80 replicates (tested twice per day for 20 days, n=80) for each spiked concentration level (0, 75, 150, 225, 300, 375, 450, 525, 600 ng/mL).
• Accuracy Study (Patient Samples): 100 patient samples.
• Linearity Study: 5 replicates for each spiked concentration level (12 levels including 0).
• Specificity & Cross-Reactivity: Not explicitly stated but implied to be multiple tests for each substance and concentration.
• Interference (pH, Endogenous Substances, Specific Gravity): Not explicitly stated, but "controls were detected accurately" implies sufficient testing for each condition.

Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission to the FDA, it can be inferred the data was generated under conditions suitable for regulatory review, likely from laboratory settings. The "patient samples" for the accuracy study would be clinical specimens.

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

• For the Accuracy study, the ground truth for the 100 patient samples was established using LC-MS/MS (Liquid Chromatography/tandem mass spectrometry), which is specified as the "preferred confirmatory method" and is an analytical chemical method, not based on expert consensus. Therefore, no human experts were used to establish the ground truth in this context. LC-MS/MS itself is considered a highly sensitive and specific gold standard for drug confirmation.
• For the Precision study, ground truth was based on the known spiked concentrations using LC-MS/MS for confirmation.
• For the Linearity study, ground truth was based on the known spiked concentrations confirmed with LC-MS/MS data.
• For Specificity, Cross-Reactivity, and Interference studies, ground truth was based on known concentrations of spiked substances.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for the accuracy study was established by LC-MS/MS, an objective analytical method. There was no need for human expert adjudication of results against another human interpretation.

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 an in-vitro diagnostic assay for detecting substances in urine, not an imaging or diagnostic AI tool that assists human readers.

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

Yes, the studies presented are all standalone performance evaluations of the assay system (device and analyzer) without human-in-the-loop performance influencing the primary analytical result. The assay directly reports qualitative (positive/negative) or semi-quantitative results. Clinical interpretation and professional judgment are advised after the preliminary analytical test result.

7. The Type of Ground Truth Used

The primary ground truth used for performance evaluation (e.g., accuracy, precision, linearity) was the objective analytical measurement by LC-MS/MS (Liquid Chromatography/tandem mass spectrometry), which is considered a gold standard confirmatory method (sometimes referred to as a "Reference Method"). For spiked samples, the ground truth was the known spiked concentration confirmed by LC-MS/MS.

8. The Sample Size for the Training Set

This document does not specify a separate "training set" or its size. In the context of an immunoassay, the concept of a training set as used in machine learning (where algorithms learn from data) is typically not applicable in the same way. The development of an immunoassay involves optimizing reagent formulations, antibody specificity, and assay conditions rather than training a predictive algorithm on a dataset.

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

Since a "training set" in the machine learning sense is not explicitly mentioned or applicable for this type of immunoassay development, the method for establishing its ground truth is not described. The manufacturer would have performed extensive R&D and optimization during method development to achieve the desired performance characteristics which were then validated in the studies described.

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