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The CEDIATM 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.

CEDIA technology 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. These fragments spontaneously re-associate to form fully active enzymes that, in the assay format, cleave a substrate. This generates a color change that can be measured spectrophotometrically.

CEDIA™ Heroin Metabolite (6-AM) Assay is supplied as a two liquid and two lyophilized reagent kit homogeneous enzyme immunoassay. The assay uses an antibody that is specific for 6-Acetylmorphine and cross reacts with Heroin. The assay has minimal cross reactivity to structurally related and unrelated compounds. In the assay, analyte in the sample competes with analyte coniugated to one inactive fragment of B-galactosidase 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 conjuqated 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 provided FDA 510(k) summary for the Microgenics Corporation CEDIA™ Heroin Metabolite (6-AM) Assay (K231007) does not contain the detailed information necessary to fully address all aspects of your request. This document is a summary of the device's substantial equivalence to a predicate device, not a complete study report.

Specifically, the document does not contain details regarding the study design, sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. The studies mentioned are focused on analytical performance characteristics (precision, spike recovery, dilution linearity, method comparison, specificity, stability) relevant to an in vitro diagnostic assay, rather than a typical AI/ML device assessment.

However, I can extract the available information regarding acceptance criteria and reported device performance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size:
  • For Precision / Spike Recovery in Qualitative Mode: "All 20 replicates of spiked 7.5 ng/mL and 12.5 ng/mL samples" were used. This indicates 20 replicates for each of these two concentrations, plus presumably samples for the 10 ng/mL cutoff for comparison. The total number of individual samples is not explicitly stated beyond these replicates for specific concentrations.
  • For Method Comparison: No specific number for the test set is provided, only percentages of agreement.
  • For Specificity (Interference): "tested concentrations" are mentioned, but the number of samples is not provided.
  • For Reagent Stability: "one lot" for on-board, reconstituted, and open vial stability, and "three lots" for real-time stability.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The studies appear to be laboratory-based analytical performance studies. The "human urine" matrix is mentioned, indicating human samples were used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. For in vitro diagnostic devices like this assay, "ground truth" is typically established through a reference method (e.g., LC-MS/MS or GC/MS for drug levels) not by human experts interpreting images or other complex data.

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

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of medical images or other subjective data where consensus among experts is needed. For an immunoassay, the "ground truth" is determined by a quantitative chemical method, not by expert consensus.

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

This information is not applicable/not provided. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interact with or are assisted by the AI. This device is an in vitro diagnostic immunoassay, not an AI imaging or diagnostic algorithm designed to assist human readers.

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

This information is not applicable/not provided in the context of AI algorithms. This device is an immunoassay, and its "standalone performance" is what is described in the precision, spike recovery, dilution linearity, and specificity sections. It's an automated chemical analysis, not an AI algorithm performing a task without human intervention in an AI/ML sense.

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

The document mentions that for confirmation, "A more specific alternative chemical method must be used...Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography with tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method." This indicates that confirmatory chemical analysis (LC-MS/MS or GC/MS) serves as the "ground truth" or reference method for determining the presence and concentration of 6-Acetylmorphine in urine samples.

8. The sample size for the training set

This information is not provided. The development of an immunoassay may involve optimization and calibration with a set of samples, but these are typically not referred to as a "training set" in the context of machine learning.

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

This information is not provided. Similar to point 8, the concept of a "training set" and its "ground truth" establishment as used in AI/ML is not directly applicable or documented for this type of in vitro diagnostic device in this summary. The development process would involve optimizing the assay's chemical components and reaction parameters using well-characterized samples.

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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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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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