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The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system to detect opiates in human saliva with a cutoff of 30 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt) and diluted with 1 mL of buffer. The calibrators and controls of the analyte Morphine are prepared with oral fluid buffer so that it can be used to verify and validate the assay. The assay is intended for use in the qualitative determination for opiate drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.

The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system 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) 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.

LZI's Oral Fluid Opiate Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect Opiate in oral fluid with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme and free drug from the saliva sample for a fixed amount of specific antibody. In the absence of free drug from the saliva sample the specific antibody binds to the drug labeled G6PDH enzyme causing a decrease in enzyme activity. It is therefore the drug concentration is proportional to the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.

The provided text describes the LZI Opiate Oral Fluid Homogeneous Enzyme Immunoassay. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on establishing substantial equivalence to a predicate device rather than explicitly stating acceptance criteria in a quantitative table. However, the "Comparison to Predicate Device" section implicitly outlines key performance characteristics that are likely considered for equivalence. The study described focuses on analytical performance, specifically to demonstrate accuracy around the specified cutoff.

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

The provided text does not explicitly state a sample size for a "test set" in the context of a clinical performance study. The studies described appear to be analytical performance studies rather than clinical trials with patient samples.

• Spike Recovery Study: Used samples "spiked" with known concentrations of morphine. The number of samples/replicates is not specified.
• Precision Study: Conducted using "three levels of controls repeatedly" (number of replicates not specified).
• Specificity/Cross-reactivity: Tested "various, common prescription drugs and abused drugs." (Number of drugs and concentrations not specified).
• Method Comparison with GC/MS: Compared 118 oral fluid specimens. The provenance (country of origin, retrospective/prospective) of these 118 specimens is not stated.

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

Not applicable. The ground truth for the analytical studies was established through:

• Known concentrations: For the spike recovery study.
• Reference method (GC/MS): For the method comparison study. GC/MS results are considered the "gold standard" for drug confirmation. No human experts were involved in establishing the ground truth for these analytical performance studies in this context.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or subjective assessment that would require an adjudication method. The studies are objective analytical performance evaluations.

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 device is an automated, homogeneous enzyme immunoassay for detecting opiates. It does not involve human readers interpreting images or data where AI assistance would be a factor.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are standalone analytical performance evaluations of the device's ability to detect opiates. The "algorithm" here refers to the immunoassay's chemical reaction and measurement process.

7. The Type of Ground Truth Used

• Known concentrations: For spike recovery (morphine concentration).
• GC/MS (Gas Chromatography/Mass Spectrometry): For the method comparison study, GC/MS served as the definitive method for confirming the presence and concentration of opiates in oral fluid specimens.

8. The Sample Size for the Training Set

Not explicitly stated. This device is an immunoassay, not a machine-learning algorithm in the modern sense that typically involves a distinct "training set" for model development. The development of such assays involves iterative optimization of reagents and conditions, which would utilize various "samples" during R&D, but not in the formalized machine learning "training set" context.

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

Not applicable in the machine learning sense. The "ground truth" during the development of this immunoassay would involve:

• Using known concentrations of morphine and its metabolites.
• Testing known positive and negative oral fluid samples (potentially characterized by GC/MS).
• Optimizing reagent concentrations and reaction conditions to achieve desired sensitivity, specificity, and cutoff performance.

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