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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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The Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates and Phencyclidine, 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 (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only.

The OralTox Oral fluid Drug Test is immunochromatographic assay that uses a lateral flow system for the qualitative detection of Amphetamine, Cocaine, Cannabinoids, Methamphetamine, Opiates and Phencyclidine (target analytes) in human oral fluid. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

The document provided is a 510(k) summary for the Premier Biotech Inc. OralTox Oral Fluid Drug Test. It describes the device, its intended use, and the performance studies conducted to demonstrate substantial equivalence to a predicate device.

Key takeaway for the Acceptance Criteria and Study:

The acceptance criteria for this device, a qualitative drug test, are primarily established through analytical performance studies, specifically assessing precision/reproducibility around the cutoff concentrations, and method comparison studies against a reference method (LC/MS/MS). The device's performance is demonstrated by the percentage of correct results for samples at various concentrations relative to the defined cutoff values.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria as a percentage or specific threshold for "correct results" within the tables. However, based on the presentation of "The percentage of correct results (%)", the implicit acceptance criterion is a high percentage of agreement with the LC/MS/MS reference method, especially for drug-free samples, samples less than half the cutoff, and high positive samples (where 100% agreement is consistently achieved). For "near cutoff" samples, some deviation is expected due to the nature of a qualitative test and the inherent variability around the cutoff.

Here's a consolidated table of reported device performance based on the "Method Comparison Studies" for each drug:

Note: There appears to be a typo in the "Cannabinoids" table for "Drug-Free" in the "No. of Negative" column (327 instead of 359). Assuming the percentage is truly 100%, the negative count should be 359.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • The "Method Comparison Studies" involved a total of 852 samples across all drug types. The sample sizes for each drug category within these studies are detailed in the table above, ranging from 477 (Phencyclidine) to 852 (Methamphetamine, although the overall total is stated as 852, so these numbers represent the number of samples relevant to each specific drug).
  • For the "Precision-Reproducibility-Cut-Off" studies, 60 tests were performed for each concentration of each drug across 3 lots (2 runs per day for 10 days per device lot, resulting in 2x10x3 = 60 tests per concentration). There were 9 concentrations tested for each drug, leading to 540 tests per drug type for this study (60 x 9).
• Data Provenance: The document does not specify the country of origin of the data. It mentions that the "Method comparison studies for the Oral fluid Drug Test were performed at three testing sites." The data appears to be prospective as samples were tested using the OralTox device and compared to LC/MS/MS results.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of "experts" in the context of establishing ground truth for the test set. The ground truth was established by Liquid Chromatography/Mass Spectrometry (LC/MS/MS), which is a highly accurate analytical method, not human expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. As the ground truth was established by LC/MS/MS, a machine-based analytical method, there was no human "adjudication" process needed. The comparison was direct between the device's qualitative result and the quantitative LC/MS/MS result interpreted against the cutoff.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a qualitative in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

6. Standalone Performance (Algorithm Only)

The performance described in the "Analytical Performance" and "Comparison Studies" sections represents the standalone performance of the OralTox Oral Fluid Drug Test. This device is an immunochromatographic assay; it does not involve a separate "algorithm" in the typical sense of AI/ML. The results presented are the device's ability to correctly classify samples based on its chemical/biological reaction, without human interpretation beyond reading the visual result.

7. Type of Ground Truth Used

The primary ground truth used for the comparison studies was Liquid Chromatography/Mass Spectrometry (LC/MS/MS). For the precision studies, samples were prepared by spiking known concentrations of drugs into negative oral fluid samples, and these concentrations were confirmed by LC/MS/MS. This is considered an analytical, highly accurate method for determining drug concentrations.

8. Sample Size for the Training Set

The concept of "training set" is not applicable here. This device is a chemical assay, not a machine learning or AI model that requires a training set. Its "performance" is based on its inherent analytical characteristics determined through laboratory testing with controlled and real-world samples.

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

Not applicable, as there is no training set for this type of device.

In summary: The OralTox Oral Fluid Drug Test demonstrates its acceptance criteria through robust analytical and method comparison studies, relying on LC/MS/MS as the gold standard for ground truth. The device's performance is shown to be highly accurate, especially for drug-free and high-positive samples, with expected variability around the defined cutoff concentrations.

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