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The Immunalysis Cannabinoids Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 50ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Cannabinoids in human urine with automated clinical chemistry analyzers. This assay is calibrated against 11-nor-9-carboxy-A9-THC (cTHC). This in-vitro device is for prescription use only.

The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.

The Immunalysis Cannabinoids Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Immunalysis cTHC Urine Control Set: The Immunalysis cTHC Urine Control Set is used as control materials in the Immunalysis Cannabinoids Urine Enzyme Immunoassay.

Immunalysis cTHC Urine Calibrators: The Immunalysis cTHC Urine Calibrators are used as calibrators in the Immunalysis Cannabinoids Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Cannabinoids in urine on automated clinical chemistry analyzers.

The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal and polyclonal antibodies to Cannabinoids, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Cannabinoids derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use.

All of the Immunalysis cTHC Urine Calibrators and Controls are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture.

The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators, as well as the LOW Control and HIGH Control are prepared by spiking known concentrations of 11-nor-9-carboxy-Δ'-THC (cTHC) into the negative calibrator matrix. The negative calibrator, Level 1 calibrator, Level 2 calibrator, Level 3 calibrator, Level 4 calibrator and two controls are sold as individual bottles.

The document describes the Immunalysis Cannabinoids Urine Enzyme Immunoassay, its calibrators, and control set, which are intended for qualitative and semi-quantitative analysis of Cannabinoids in human urine with a cutoff of 50ng/mL. The study evaluates the performance of the device against this cutoff.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document for each test. However, the studies demonstrate the device's performance relative to its intended use and consistency around the 50 ng/mL cutoff. The implicit acceptance criteria appear to be:

• Qualitative Analysis: Accurate classification of samples as negative below the -25% cutoff and positive above the +25% cutoff, with consistent results at the cutoff.
• Semi-Qualitative Analysis: Similar to qualitative, with consistent results around the cutoff.
• Specificity and Cross-Reactivity: Structurally similar compounds should show expected cross-reactivity, and structurally dissimilar compounds should not interfere.
• Interference: Various endogenous compounds, pH levels, and specific gravity should not cause interference.
• Recovery: Expected concentrations should be recovered within an acceptable range.
• Method Comparison: High agreement with LC/MS confirmation for both qualitative and semi-quantitative modes.
• Calibration and Control Performance: Traceability and stability of calibrators and controls within specifications.

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

• Precision/Cutoff Characterization Study:

  • Sample Size: 80 determinations for each concentration level (0 ng/mL, 12.5 ng/mL, 25 ng/mL, 37.5 ng/mL, 50 ng/mL, 62.5 ng/mL, 75 ng/mL, 87.5 ng/mL, 100 ng/mL). This totals 720 determinations for the qualitative and semi-quantitative analysis sections combined (80 x 9 concentrations). The document states "20 days, 2 runs per day in duplicate (N=80)" for each concentration, which implies the N=80 refers to the total number of measurements for that specific concentration over the study period.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The samples for this specific study were likely artificially prepared (spiked) to control concentrations precisely. This would be a prospective study using controlled samples.

• Specificity and Cross-Reactivity Study:

  • Sample Size: Not explicitly stated per compound, but each compound was "spiked into drug free urine at levels that will yield a result that is equivalent to the cutoffs."
  • Data Provenance: Artificially prepared samples (spiked into drug-free urine). This is a prospective study using controlled samples.

• Interference Study:

  • Sample Size: Not explicitly stated per compound. Each potential interferent was "spiked into drug free urine containing the target analyte at ±25% of the cutoff."
  • Data Provenance: Artificially prepared samples (spiked into drug-free urine). This is a prospective study using controlled samples.

• Recovery Study:

  • Sample Size: Not explicitly stated for each dilution, but a drug-free urine pool was spiked and serially diluted.
  • Data Provenance: Artificially prepared samples (spiked into drug-free urine). This is a prospective study using controlled samples.

• Method Comparison Study:

  • Sample Size: 80 clinical urine samples (40 positive, 40 negative) for both qualitative and semi-quantitative evaluations.
  • Data Provenance: "Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories." This indicates retrospective clinical samples, but the country of origin is not specified.

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

• For Precision/Cutoff, Specificity, Interference, Recovery: The ground truth was established by known concentrations of analytes (spiked samples) and the inherent characteristics of the chemicals themselves. No human expert consensus was required for these controlled laboratory studies
• For Method Comparison Study: The ground truth was established by Liquid Chromatography/Mass Spectrometry (LC/MS) or Gas Chromatography/Mass Spectrometry (GC-MS). The document explicitly states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method." While it doesn't specify the number or qualifications of experts operating the LC/MS, these are highly trained laboratory professionals.

4. Adjudication Method for the Test Set

• Given that the primary ground truth relies on LC/MS (a highly accurate quantitative method) for clinical samples and known concentrations for spiked samples, no human adjudication method (like 2+1 or 3+1 consensus) was necessary or mentioned. The LC/MS results serve as the definitive reference.

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, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay for chemical analysis in urine, not an imaging or AI-assisted diagnostic tool that would involve human "readers" interpreting results improved by AI. The document describes traditional laboratory performance studies for a chemical immunoassay.

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

• Yes, this entire study represents a standalone performance evaluation of the Immunalysis Cannabinoids Urine Enzyme Immunoassay. The device itself (the immunoassay kit run on automated clinical chemistry analyzers) operates without direct human-in-the-loop decision-making during the assay process, beyond sample loading and results interpretation which is standard for IVD. The data tables show "Result" obtained from the device.

7. The Type of Ground Truth Used

• For controlled studies (Precision/Cutoff, Specificity, Interference, Recovery): Known concentrations of analytes (spiked samples) serve as the ground truth.
• For clinical sample comparison (Method Comparison): Liquid Chromatography/Mass Spectrometry (LC/MS) or Gas Chromatography/Mass Spectrometry (GC-MS) was used as the confirmatory ground truth.

8. The Sample Size for the Training Set

• This document describes studies for regulatory submission (510(k)), which focus on verification and validation of a developed product.
• No information is provided about a "training set" because this is an in vitro diagnostic assay, not typically an AI/machine learning algorithm that requires a separate, explicitly defined "training set" in the context of the performance studies presented. The immunoassay functions based on chemical reactions, not on learning from data similar to an AI model.

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

• As a training set is not explicitly mentioned or relevant for this type of immunoassay, this question is not applicable to the provided document. The "ground truth" concept applies to the test sets for performance evaluation (as described in point 7), not to an algorithm's training process for this device.

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