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The Cocaine Metabolite (Benzoylecgonine) Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect cocaine metabolite in human saliva with a cutoff of 15 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 (Benzoylecgonine) 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 cocaine/cocaine metabolite drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.

The Cocaine Metabolite (Benzoylecgonine) Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoasay 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-ofabuse test result, particularly when preliminary positive results are used.

LZI's Oral Fluid Cocaine Metabolite (Benzoylecgonine) Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect benzoylecgonine in oral fluid with minimal crossreactivity 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.

Here's a breakdown of the acceptance criteria and the study details for the LZI Cocaine Metabolite (Benzoylecgonine) Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device and provides performance characteristics rather than explicit "acceptance criteria" in the sense of predefined thresholds. However, we can infer some criteria from the presented data, particularly in comparison to the predicate device. The key performance metrics reported are accuracy, within-run precision, and total precision.

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

• Accuracy Test (Clinical Patients Samples):
  • Sample Size: 118 samples (n=118)
  • Data Provenance: Not explicitly stated, but clinical patient samples are used, implying real-world data. The country of origin is not specified, but the submission is to the US FDA. The study appears to be prospective since it's providing data for pre-market notification.
• Qualitative (Precision) Test:
  • Sample Size: 120 samples (n=120) for "Qualitative : (n=120) mA/min". This likely refers to the number of measurements rather than distinct individuals.
  • Data Provenance: Not specified, but likely laboratory-controlled samples, not clinical patient data. Presumably prospective.

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

• Number of Experts: Not applicable in this context.
• Qualifications of Experts: Not applicable.

For this type of in-vitro diagnostic device, the "ground truth" for drug detection is established by a more definitive analytical method, not by expert consensus in the human interpretation sense.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The "adjudication" is done by comparing the device's results directly against the quantitative results of the GC/MS method.

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:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This is an in-vitro diagnostic device, not an imaging device or one that involves human interpretation of complex data where "readers" are involved in the traditional sense.

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

• Standalone Performance: Yes, the described studies represent standalone performance. The device is an automated immunoassay system that provides a preliminary analytical result. Its accuracy and precision are evaluated independently against a gold standard (GC/MS) or against internal measures. There isn't a "human-in-the-loop" component for the device's direct output. Human professional judgment is still required for interpreting the results in a clinical context, but this is separate from the device's technical performance.

7. The Type of Ground Truth Used:

• Ground Truth: For the accuracy study, the ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method." and "Accuracy: Clinical patients samples (n=118) vs. GC/MS".

8. The Sample Size for the Training Set:

• Training Set Sample Size: The document does not provide details on a specific "training set" size. For laboratory developed immunoassays like this, the development and optimization process (which could be considered analogous to "training") involves various reagent formulations, calibration curves, and testing. However, a distinct, quantifiable "training set" as understood in machine learning is not described. The provided data focuses on the validation of the final product.

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

• Ground Truth for Training Set: Since a distinct training set and its ground truth are not explicitly described in the context of this traditional immunoassay, this information is not available in the provided text. The overall method development and validation would rely on established analytical chemistry principles and comparison to reference methods like GC/MS at various stages.

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