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The CEDIA Heroin Metabolite (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 method must be used to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) or Liquid chromatography with tandem 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 lyophilized reagents (1a and 2a). The components include mouse monoclonal antibodies to 6-Acetylmorphine, recombinant microbial "enzyme donor" - 6-Acetylmorphine conjugate, "enzyme acceptor", chlorophenol red ß-Dgalactopyranoside, stabilizers and preservatives.

Here's a summary of the acceptance criteria and study details for the CEDIA Heroin Metabolite (6-AM) Assay, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size:
  • Precision Studies: 80 samples for both qualitative and semi-quantitative modes (two replicates per run, twice a day, for 20 days). These samples were spiked at various concentrations relative to the cutoff (0, 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20 ng/mL).
  • Analytical Recovery and Dilution Linearity: Drug-free urine spiked to 20 ng/mL and diluted to generate 10 intermediate levels. Each sample was run in replicates of five.
  • Method Comparison and Accuracy: 103 patient samples.
  • Specificity (Cross-reactivity): Varies per compound, usually tested at one high concentration for structurally related/unrelated compounds, and two control levels (7.5 ng/mL and 12.5 ng/mL) for "structurally unrelated compounds spiked at the concentration listed below into Low Control and High Control".
  • Interference (Endogenous & pH): Low Control (7.5 ng/mL) and High Control (12.5 ng/mL) samples, spiked with various interfering substances.
  • Interference (Specific Gravity): Drug-free urine samples separated into 11 specific gravity levels, then each spiked at Low Control (7.5 ng/mL) or High Control (12.5 ng/mL).
• Data Provenance: The document does not explicitly state the country of origin. The studies are described as analytical performance studies conducted by the manufacturer (Microgenics Corporation, Fremont, CA, USA). The studies appear to be prospective for the current submission, though some stability data references previous 510(k) submission (K173183).

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth in the traditional sense (e.g., radiologists, clinicians reviewing images). For this type of in vitro diagnostic device (immunoassay), the "ground truth" for the test set is established by a highly accurate and precise reference method.

4. Adjudication Method for the Test Set

Not applicable. For this type of in vitro diagnostic, adjudication by human experts is not typically used for establishing ground truth. The comparison is made against a validated confirmatory laboratory method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is an in vitro diagnostic assay, not an imaging device or AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

6. Standalone Performance

Yes. The entire document describes the standalone performance of the CEDIA Heroin Metabolite (6-AM) Assay in both qualitative and semi-quantitative modes. The performance metrics (precision, accuracy, specificity, interference, stability) are all evaluated for the assay itself, without a human-in-the-loop component.

7. Type of Ground Truth Used

The primary ground truth for the test set (method comparison and accuracy, as well as for spiking concentrations in other studies) was established using Liquid Chromatography/tandem mass spectrometry (LC-MS/MS), and potentially Gas chromatography/mass spectrometry (GC/MS), as these are stated as the "preferred confirmatory methods."

8. Sample Size for the Training Set

Not applicable. This is an immunoassay, not a machine learning or AI-based device that would typically have a separate "training set" for model development. The reagents are chemical components that react based on established biochemical principles.

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

Not applicable, as there is no "training set" in the context of an immunoassay. The development of the assay's reagents and methodologies would rely on chemical and biochemical principles and rigorous validation against known standards and reference methods.

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