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The CEDIA Heroin Metabolite (6-Acetylmorphine, or 6-AM) Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and/or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine at a cut-off concentration of 10 ng/mL. The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect 6-Acetylmorphine in human urine. The assay is designed for use with a number of clinical chemistry analyzers. This product is intended to be used by trained professionals only.

The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) or Liquid chromatography/ mass spectrometry (LC-MS/MS) is the preferred confirmatory method.

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

The assay consists of buffers (1 and 2) and Ivophilized reagents (1a and 2a). The components include mouse monoclonal antibodies to 6-Acetylmorphine, recombinant microbial enzyme donor (ED) – 6-Acetylmorphine conjugate: enzyme acceptor (EA), chlorophenol red 3-D-galactopyranoside; stabilizers and preservatives. Calibrators and controls are sold separately.

The document describes the analytical performance of the CEDIA Heroin Metabolite (6-AM) Assay for detecting 6-Acetylmorphine in human urine. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as a target range for each metric, but rather implied by the successful demonstration of performance in each analytical study. The reported device performance is provided in detailed tables for each study.

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

• Precision Study: 80 replicates (2 runs/day, 2 times a day for 20 days) for each of the 9 spiked concentrations (total 720 tests per mode, Qualitative and Semi-Quantitative).
• Spike Recovery: 20 replicates for each of the 3 spiked concentrations (total 60 tests per mode, Qualitative and Semi-Quantitative).
• Analytical Recovery and Linearity: Replicates of five for each of the 11 intermediate levels created from dilutions. Total 55 tests.
• Method Comparison and Accuracy: 100 unaltered patient samples.
• Specificity (Cross-Reactivity): Varies per substance, but single concentrations were tested for each compound.
• Interference (pH and Endogenous Substances): Single concentrations were tested for each compound, at both Low and High Control levels.
• Specific Gravity: Unspecified number of samples across the range of 1.002 to 1.030, tested at both Low and High Control levels.

Data Provenance: The studies were performed at the manufacturer's site (Microgenics Corporation, Thermo Fisher Scientific, Fremont, CA). The data appears to be prospective as it involves controlled spiking of samples and testing in a laboratory setting to evaluate the device's performance characteristics. The specific country of origin for the patient samples in the method comparison study is not mentioned, but given the manufacturer's location, it is likely the United States. The term "unaltered patient samples" implies a retrospective collection of samples if they were banked, but the testing itself was prospective.

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

For the CEDIA Heroin Metabolite (6-AM) Assay, the "ground truth" for the test set (primarily for method comparison and accuracy) was established by Liquid Chromatography/tandem mass spectrometry (LC-MS/MS). This is an analytical chemical method, not human expert interpretation. Therefore, the concept of "number of experts" and their "qualifications" in the traditional sense of medical image or clinical diagnosis interpretation does not directly apply here. LC-MS/MS is considered the definitive confirmatory method for drug concentration.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth is established by a definitive analytical method (LC-MS/MS), not by human interpretation requiring adjudication. Any discrepancies between the assay and LC-MS/MS are analyzed and explained (e.g., the one discordant sample in the method comparison was attributed to cross-reactivity with morphine).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an in vitro diagnostic immunoassay, not an AI-assisted diagnostic tool that aids human readers (e.g., radiologists interpreting images). The study focuses on the assay's analytical performance against a gold standard chemical method, not on human interpretive performance.

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

This is fundamentally a "standalone" or "algorithm only" study in the context of IVD devices. The CEDIA Immunoassay operates as an automated system on clinical chemistry analyzers, generating a result without direct human interpretation of a visual output that would then be further modified by a human. While trained professionals operate the analyzer, the core measurement and qualitative/semi-quantitative determination are performed by the device itself based on the chemical reaction. The performance metrics reported are for the device's output compared to a reference method.

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

The primary ground truth used is confirmatory analytical methods, specifically Liquid Chromatography/tandem mass spectrometry (LC-MS/MS). This is considered the "gold standard" for precise and accurate quantification of drug metabolites in biological samples. For other studies like precision or linearity, the ground truth is the known spiked concentrations of 6-acetylmorphine into drug-free urine.

8. The Sample Size for the Training Set

Not applicable. This device is an immunoassay, not an AI/machine learning model that requires a distinct "training set" in the computational sense. The "development" or "training" of such assays involves chemical formulation and optimization, followed by rigorous analytical validation studies as described.

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

Not applicable (as explained in point 8). The assay's chemical reagents and methodology are developed and optimized based on chemical principles and prior knowledge of enzyme immunoassays, rather than learning from a labeled training dataset in the AI sense.

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