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The Emit II Plus Oxycodone Assay is a homogeneous enzyme immunoassay with 100 ng/mL cutoff. The assay is intended for in vitro diagnostic use in the qualitative and semiquantitative determination of oxycodone in human urine. The Emit II Plus Oxycodone Assay is designed for use with a number of clinical chemistry analyzers. The semiquantitative mode is for the purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Mass Spectrometry (LC/MS) or permitting laboratories to establish quality control procedures.

The Emit II Plus Oxycodone Assay provides only a preliminary analytical test result. A more specific alternative chemical method(s) must be used to obtain a confirmed analytical test result. Gas Chromatography/Mass Spectrometry (GC/MS) and LC/MS are the preferred confirmatory methods. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

The Emit® II Plus Oxycodone assay is a homogeneous enzyme immunoassay with 100 ng/mL and 300 ng/mL cutoffs. The assay, used for the detection of oxycodone in human urine, utilizes a two- reagent system. The Antibody/Substrate Reagent 1 is a liquid ready-to-use product comprised of mouse monoclonal antibodies to oxycodone, qucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in a diluent containing bovine serum albumin (BSA), preservatives and stabilizers. The Enzyme Reagent 2 is a liquid, ready-to-use product containing oxymorphone labeled with bacterial recombinant glucose-6 phosphate dehydrogenase (rG6PDH) in a diluent containing bovine serum albumin (BSA), HEPES buffer, preservatives and stabilizers.

The assay kit consists of Reagent 1 and Reagent 2 in plastic containers and is available in three sizes: 1000 mL/500 mL, 115 mL/50 mL, and 28 mL/14 mL. Emit® II Plus assays are designed for use with a number of chemistry analyzers. The Emit® II Plus Oxycodone assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result.

The Siemens Healthcare Diagnostics Inc. Emit II Plus Oxycodone Assay is a homogeneous enzyme immunoassay intended for in vitro diagnostic use in the qualitative and semiquantitative determination of oxycodone in human urine. It has two cutoffs: 100 ng/mL and 300 ng/mL.

The study presented focuses on demonstrating substantial equivalence to the predicate device, DRI Oxycodone Assay (K040411), through non-clinical performance evaluations.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state pre-defined acceptance criteria values (e.g., "sensitivity must be > X"). Instead, the performance is reported as observed agreement rates with the confirmatory method (LC-MS/MS) and precision metrics. The implicit acceptance criterion is that the device's performance is comparable to or meets expected standards for drug screening assays, similar to its predicate.

2. Sample sizes used for the test set and data provenance:

• Method Comparison: 100 unaltered native patient samples were tested for each cutoff (100 ng/mL and 300 ng/mL), totaling 200 samples.
• Precision: Urine pools spiked with oxycodone at nine different levels for each cutoff were used. Each level was tested with two replicates, twice a day, for twenty days (n = 80 per level per cutoff). This means 9 levels * 80 replicates * 2 cutoffs = 1440 tests for precision.
• Recovery: 7 concentrations for the 100 ng/mL cutoff and 13 concentrations for the 300 ng/mL cutoff were evaluated. Each concentration was analyzed in replicates of 5. This means 7 concentrations * 5 replicates + 13 concentrations * 5 replicates = 100 tests for recovery.
• Cross-Reactivity & Interference (Structurally Related, Unrelated, Endogenous): Samples were spiked into drug-free urine and evaluated. The exact number of samples for each compound isn't explicitly stated beyond referencing CLSI guidelines, but it's implied that sufficient replicates were done to determine cross-reactivity percentages or lack thereof.
• Specific Gravity and pH: Drug-free urine pools (with varying SG and pH) were spiked to 3 final oxycodone concentrations. Samples were then evaluated qualitatively and semiquantitatively. The number of samples is not explicitly stated but implied to be sufficient for assessment.

Data Provenance: The document does not explicitly state the country of origin for the native patient samples or whether they were retrospectively or prospectively collected. However, the study was conducted by Siemens Healthcare Diagnostics Inc., based in Newark, DE, USA.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

The ground truth for the method comparison study was established using Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS), which is considered a highly specific and sensitive confirmatory method for drug analyses. This is a laboratory-based analytical technique, not an expert panel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

No multi-reader adjudication method was used for the test set. The ground truth was established by LC-MS/MS, a quantitative chemical analysis method.

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 MRMC comparative effectiveness study was done. This device is an in vitro diagnostic assay, not an imaging AI device that would typically involve human readers.

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

The performance reported is for the standalone device (Emit II Plus Oxycodone Assay) on a clinical chemistry analyzer without human interpretation influencing the result of the assay itself. The results are preliminary and require confirmation by LC/MS or GC/MS, implying a human-in-the-loop step for final clinical interpretation and confirmation. However, the performance of the assay itself is standalone.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The primary ground truth for method comparison was Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS), a highly sensitive and specific chemical analytical method. For spiked samples used in precision, recovery, and cross-reactivity studies, the ground truth was the known concentration of the spiked compound.

8. The sample size for the training set:

This document describes a performance evaluation study for a chemical assay, not a machine learning or AI model. Therefore, there is no "training set" in the context of AI. The assay's parameters would have been developed and optimized during its design phase using internal validation processes, for which detailed sample sizes are not provided in this regulatory submission.

9. How the ground truth for the training set was established:

As this is not an AI/machine learning device, there isn't a "training set" in that sense. The assay works based on established biochemical principles (enzyme immunoassay). Its development would involve calibrating and optimizing its response to known concentrations of oxycodone and its metabolites, using chemically prepared standards and samples quantified by reference methods.

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