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The CEDIA® Amphetamine OFT Assay is intended for use in the qualitative determination of amphetamine in human oral fluid at a cutoff concentration of 150 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze ™ Saliva Collection System. The assay is calibrated against d-amphetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Amphetamine OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liguid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to anv drug of abuse test result particularly when preliminary positive results are used.

The CEDIA® Amphetamine OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ßgalactosidase, which has been genetically engineered into two inactive fragments i.e., enzyme acceptor (EA) and enzyme donor (ED). These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.

In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment of ß-qalactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample.

The Oral-Eze™ Saliva Collection System consists of Oral-Eze™ saliva collection tube with preservative buffer. Oral-Eze™ saliva collector consists of an absorbent pad attached to a plastic handle. The saliva collector is provided with a volume adequacy indicator. The plastic handle has a round window where blue color will appear when sufficient volume of oral fluid is collected. Samples are collected by placing the collector pad and plastic shield between lower cheek and gum with the plastic shield facing the cheek. Oral fluid collection is done when blue color appears in the window of the handle. The pad is ejected in to the collection tube by placing thumb on the ridges on the handle and pushing the thumb forward. The collection tube is capped and sent to the laboratory for processing and testing.

This document describes the performance testing and acceptance criteria for the CEDIA® Amphetamine OFT Assay.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each of the performance tests (Qualitative Precision, Qualitative Cutoff Characterization, Interference, Specificity and Cross-Reactivity, and Amphetamine Method Comparison).

The data provenance is not explicitly stated in terms of country of origin. However, the device is intended for clinical laboratory use, implying that the samples would typically originate from such settings. The nature of the tests (e.g., "samples at levels below the cutoff," "samples at levels above the cutoff," "endogenous and exogenous substances") suggests controlled laboratory experiments, and potentially spiked or characterized samples, rather than purely retrospective or prospective collection of patient samples. For the Amphetamine Method Comparison, "sample results" are compared to GC/MS, implying collected samples, but the source (e.g., clinical specimens, spiked controls) is not detailed.

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

The document does not mention the use of experts to establish ground truth in the traditional sense of human interpretation for image-based or diagnostic decisions. For the Amphetamine Method Comparison, the ground truth is established by Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), which are considered the "preferred confirmatory methods." These are objective analytical methods, not human expert consensus.

4. Adjudication Method for the Test Set:

Not applicable. The ground truth for the method comparison is based on objective analytical techniques (GC/MS, LC-MS/MS), not human interpretation requiring adjudication.

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:

Not applicable. This is an in vitro diagnostic device (an assay for chemical analysis), not an AI-assisted diagnostic tool that would involve human readers or interpreters.

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

Yes, the performance data presented is for the device operating in a standalone capacity (algorithm/assay only). The results of the CEDIA® Amphetamine OFT Assay are directly compared to the confirmatory methods (GC/MS), without any human interpretation of the assay's primary output affecting the reported performance metrics. The assay provides a "preliminary analytical test result" which then requires confirmed with a "more specific alternative method."

7. The Type of Ground Truth Used:

The primary ground truth used for performance validation, specifically in the "Amphetamine Method Comparison," is Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). These are highly accurate and specific analytical techniques considered the gold standard for drug confirmation.

8. The Sample Size for the Training Set:

Not applicable. This product is a chemical assay, not a machine learning or AI algorithm that requires a training set in the typical sense. The assay's "training" or development would involve laboratory optimization and validation using chemical principles and reference materials, rather than a data-driven training set used for AI.

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

Not applicable, as there is no training set in the context of a machine learning algorithm. The assay's development and parameters would be established through standard analytical chemistry practices, using known concentrations of analytes and reference standards.

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