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The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 300 ng/mL and 2000 ng/mL. The assay is intended for use in laboratories for the qualitative andlysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. This in-vitro diagnostic 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 Opiates 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 Opiates Urine Calibrators 300

The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.

Immunalysis Multi-Drug Controls

The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.

Immunalysis Opiates Urine Calibrators 2000

The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package inset: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.

The assay consists of antibody/substrate reagent and enzyme conjugate reagent. The antibody/substrate reagent includes monoclonal antibodies to morphine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes morphine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.

All of the Immunalysis Opiates Urine Calibrators 300 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 are prepared by spiking known concentrations of morphine into the negative calibrator matrix. These five calibrators are sold as individual bottles.

All of the Immunalysis Multi-Drug 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 LOW Control 1, HIGH Control 1, LOW Control 2 and HIGH Control 2 are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These four controls are sold as control sets.

All of the Immunalysis Opiates Urine Calibrators 2000 are liquid and ready to use. Each contains a known concentration of a specific drug analyte. 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 are prepared by spiking known concentrations of morphine into the negative calibrator matrix. These five calibrators are sold as individual bottles.

The provided document describes the Immunalysis Opiates Urine Enzyme Immunoassay and related calibrators and controls. The focus of the acceptance criteria and study is on the analytical performance of the immunoassay for detecting opiates in human urine.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (e.g., minimum sensitivity or specificity values to be achieved). Instead, it presents the results of various analytical performance studies and implies that these results demonstrate substantial equivalence to predicate devices. The "reported device performance" is the outcome of these studies.

I will attempt to extract what could be interpreted as performance metrics and their results for the Immunoassay, focusing on the Qualitative Analysis and Method Comparison, as these are closest to typical acceptance criteria.

Note: The document provides performance for two cut-off levels: 300 ng/mL and 2000 ng/mL. The following table consolidates performance for both where applicable.

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

• Precision/Cutoff Characterization Study: 80 determinations for each concentration level (e.g., 0 ng/mL, 75 ng/mL, 150 ng/mL, etc.) for both 300 ng/mL and 2000 ng/mL cutoffs. This was performed over 20 days, 2 runs per day in duplicate (N=80). The samples for this study would be spiked laboratory samples (morphine in drug-free urine). The provenance is laboratory-controlled.
• Specificity and Cross-Reactivity: Compounds were spiked into drug-free urine. The number of determinations per compound is not explicitly stated but implies tests at a single "Concentration Tested."
• Interference: Potential interferents were spiked into drug-free urine containing morphine at ±25% of the cutoffs. The number of determinations per compound and condition is not explicitly stated.
• Linearity/Recovery: A drug-free urine pool was spiked with a high concentration of the target analyte, then serially diluted. The number of samples for each expected concentration is not directly stated, but the "Mean Concentration" implies multiple measurements.
• Method Comparison: "Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories" were used.
  • For the 300 ng/mL cutoff, the tables indicate a total of 80 clinical samples (40 positive by LC/MS, 40 negative by LC/MS, with one discordant result).
  • For the 2000 ng/mL cutoff, the tables indicate a total of 80 clinical samples (40 positive by LC/MS, 40 negative by LC/MS).
  • Data Provenance: Retrospective, anonymous discarded clinical urine samples. The country of origin is not specified but implicitly in the USA as per FDA submission.

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 device is an in-vitro diagnostic assay for chemical analysis. The "ground truth" for the test set (clinical urine samples) was established using Liquid Chromatography/Mass Spectrometry (LC/MS) confirmation. This is an analytical method, not human expert consensus, for determining the presence and concentration of chemical substances. Therefore, human experts were not directly used to establish the ground truth in the way they might be for interpreting medical images.

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

Not applicable. The ground truth was established by an objective analytical method (LC/MS confirmation), not by expert opinion. Therefore, no human adjudication method was required.

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 immunoassay for chemical testing, not an imaging device or an AI-assisted diagnostic tool that involves human readers.

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

The device itself is a "Homogeneous Enzyme Immunoassay," which operates as a standalone analytical test system on automated clinical chemistry analyzers. Its performance, as reported in the studies (Precision, Specificity, Interference, Linearity, and Method Comparison with LC/MS), represents its standalone performance without explicit human interpretation determining the positive/negative result (though lab personnel operate the instrument and interpret the final reported value). The "semi-quantitative mode" is explicitly stated for aiding decisions on confirmation methods or quality control, not as a human-in-the-loop diagnostic where a human modifies the device's direct output.

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

The ground truth for the clinical urine samples used in the method comparison study was established by Liquid Chromatography/Mass Spectrometry (LC/MS) confirmation, which is considered the preferred confirmatory method for drug of abuse testing.

8. The sample size for the training set

The document does not describe a "training set" in the context of machine learning or AI. This is an immunoassay, which is a chemical analytical test, not a learning algorithm. The studies performed are characterization and validation studies for the assay's analytical performance.

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

Not applicable, as this is not an AI/ML device reliant on a training set. The "ground truth" in the validation studies was established via spiked samples (known concentrations) for various performance characteristics and LC/MS for clinical sample comparison.

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