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The Chemtron Biotech, Inc.'s Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of up to six of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and the calibrators used for these drugs are as follows:

The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are intended for the qualitative detection of drugs of abuse for in vitro diagnostic and prescription use ONLY. They are not intended for point-of-care settings or over the counter use. These assays provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods.

Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The Drugs of Abuse (DOA) Screen Panels are one-step lateral flow immunoassays in which chemically modified drugs (drug-protein conjugates) compete for limited antibody binding sites with drugs that may be present in urine. The test device consists of up to six test strips placed into separate panels of a plastic holder. On each test strip, a drug-protein conjugate is striped on the test band of the membrane - known as the test region (T) and the anti-drug antibody-colloidal gold conjugate pads are placed at the forward end of the membrane.

The Chemtrue® Single/Multi-Panel Drug Screen Tests are qualitative immunoassays designed to detect up to six drugs of abuse in human urine. The acceptance criteria for this device are defined by its performance in detecting specific drugs at or above their established cutoff concentrations, as compared to a reference method (GC/MS).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Overall Agreement" percentages with the GC/MS reference method. While explicit pass/fail thresholds are not stated here, the reported high agreement percentages indicate that the device meets an acceptable level of performance for clinical utility.

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

The studies used clinical specimens for the test set.

• BZO: 203 samples (Dip Card and Cassette)
• BAR: 190 samples (Dip Card and Cassette)
• MDMA: 101 samples (Dip Card and Cassette)
• MTD: 104 samples (Dip Card and Cassette)
• OPI(MOR)2000: 106 samples (Dip Card and Cassette)
• OXY: 106 samples (Dip Card and Cassette)

The data provenance is from clinical specimens, implying a retrospective study design where samples were collected and then tested. The document does not specify the country of origin.

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

This information is not provided in the document. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical chemical method, not human expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth was established by an objective chemical method (GC/MS), not human adjudication.

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 is not applicable. The device is an immunoassay for drug screening, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are outside the scope of this device.

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

Yes, the performance study (method comparison) represents a standalone evaluation of the device. The Chemtrue® cassettes and dip cards were compared directly against the GC/MS reference method, acting as an "algorithm only" in the sense that its output (positive/negative) was assessed independently of human interpretation influence beyond reading the test lines.

7. The Type of Ground Truth Used

The ground truth used was analytical/objective data from Gas Chromatography/Mass Spectrometry (GC/MS). The document states: "Samples with drug concentration above the cut-off level were considered presumptive positive and concentration below the cut-off were considered negative." and "The product performance characteristics of were evaluated with the GC/MS confirmed values in a blind-labeled clinical specimen correlation study."

8. The Sample Size for the Training Set

The document does not provide information regarding a distinct training set. The device is a lateral flow immunoassay, a chemical sensing technology, and not typically developed using machine learning models that require explicit training sets in this context.

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

As no training set is described for this type of device, this information is not applicable. The device's performance characteristics (such as antibody specificity and cutoff concentrations) are established during the assay development and manufacturing process, not through a 'training set' in the machine learning sense.

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