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The OralTox® Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates, Phencyclidine, Oxycodone and Methadone in human oral fluid at the cutoff concentrations listed below and their metabolites:

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/ Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. It is not intended to detect intermittent dosing of Oxycodone. Clinical consideration and professional judgment should be exercised with any drug of abuse test result. particularly when the preliminary result is positive.

The OralTox Oral fluid Drug Test is an immunochromatographic assay that uses a lateral flow system for the qualitative detection of Amphetamine, Cocaine, Cannabinoids, Methamphetamine, Morphine, Phencyclidine. Oxycodone and Methadone (target analytes) in human oral fluid. The products are single-use in vitro diagnostic devices. Each test kit contains a test cup, a package insert and a sample collection sponge. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the OralTox® Oral fluid Drug Test, a competitive binding, lateral flow immunochromatographic assay for the qualitative and simultaneous detection of several drugs in human oral fluid. This submission is a 510(k) premarket notification, indicating the device is intended to be substantially equivalent to previously marketed devices.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criteria for this device are related to its analytical performance in detecting specific drugs at defined cutoff concentrations. The studies performed focus on demonstrating the accuracy and reliability of the device in comparison to a confirmed analytical method (LC/MS/MS).

Table of Acceptance Criteria and Reported Device Performance (Methadone and Oxycodone - as these were the focus of new data in this submission)

Study Details

The provided document describes analytical performance studies and method comparison studies. There is no mention of clinical studies involving patients or a human-in-the-loop (MRMC) study. The device is an in-vitro diagnostic (IVD) device, and the focus is on its analytical accuracy against a gold standard lab method.

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

   • See table above. The acceptance criteria are largely implied from the nature of the tests performed and the typical expectations for an IVD device. For example, for precision/reproducibility, the expectation is that samples significantly below the cutoff are consistently negative, and samples significantly above are consistently positive, with an acceptable range of uncertainty around the cutoff itself. For method comparison, a high percentage of agreement with the confirmatory method is expected.

2. Sample sizes used for the test set and the data provenance:

   • Precision-Reproducibility-Cut-Off: Samples were prepared at 8 concentrations (-100%, -75%, -50%, -25%, +25%, +50%, +75%, +100% of cutoff). For each concentration, tests were performed "two runs per day for 10 days per device lot." With 3 lots tested (for Oxycodone and Methadone), this means: 8 concentrations x 2 runs/day x 10 days x 3 lots = 480 samples per drug (e.g., 60 samples per concentration/lot).
   • Method Comparison Studies: "Total 932 samples" were tested across all drugs. For Oxycodone, the breakdown is: 152 drug-free, 47 less than half cutoff, 32 near cutoff negative, 29 near cutoff positive, 174 high positive = 434 samples. For Methadone, the breakdown is: 277 drug-free, 13 less than half cutoff, 20 near cutoff negative, 15 near cutoff positive, 173 high positive = 498 samples. (434 + 498 = 932 total, aligning with the stated total).
   • Data Provenance: The document does not explicitly state the country of origin. It indicates that the samples were "prepared by spiking drug in negative oral fluid samples" for precision studies. For method comparison, "Method comparison studies for the Oral fluid Drug Test were performed at eight testing sites with three operators at each site." This suggests retrospective sample collection and external lab testing for the LC/MS/MS ground truth, though the exact nature (e.g., banked samples, newly collected for the study) is not specified. The samples are human oral fluid.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The ground truth was established by Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC-MS/MS), which is described as the "preferred confirmatory method." LC-MS/MS is an analytical chemistry technique, not typically performed by "experts" in the clinical sense (like radiologists). The "ground truth" is derived from the analytical measurement itself, likely performed by trained laboratory technicians or biochemists following established protocols. Therefore, the concept of "number of experts" or "qualifications" beyond standard lab accreditation is not applicable in the way it would be for image interpretation.

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

   • No adjudication method described. The test is a qualitative assay (positive/negative based on visual line presence/absence), and the ground truth is a quantitative analytical measurement (LC-MS/MS). Discrepancies between the device result and the LC-MS/MS result are reported as discordant results, not subject to further "adjudication" by human experts in this context.

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 is an in-vitro diagnostic (IVD) device, not an AI-powered image interpretation device. It is a rapid immunoassay for drug detection. The "readers" are the individuals visually interpreting the test result (presence or absence of a line), not medical professionals interpreting complex images. The study focuses on the analytical performance of the device itself against a gold standard lab method.

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

   • This is a standalone diagnostic device. The performance data presented (precision, linearity, stability, interference, specificity, pH effect, drug recovery, and method comparison studies) characterize the standalone analytical performance of the device itself. The "human-in-the-loop" component is limited to the visual interpretation of the presence/absence of a line, which is a straightforward qualitative assessment, not a complex diagnostic decision.

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

   • The ground truth used was quantitative analytical measurement via Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC-MS/MS). For drug detection, this is typically considered the gold standard.

8. The sample size for the training set:

   • This document describes a premarket notification for an IVD device. The methods described here relate to validation/test set studies. The document does not mention a "training set" in the context of machine learning. Lateral flow immunoassays are developed and optimized through chemical and biological engineering, not by training a machine learning algorithm on a dataset.

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

   • As there is no mention of a "training set" or machine learning model in this document, this question is not applicable. The device's mechanism is based on immunochromatography (antigen-antibody reactions), not data-driven learning.

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