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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 Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device is intended for use in the collection, preservation, and transport of oral specimens. Oral specimens collected with the Intercept™ Oral Specimen Collection Device can be used to detect cocaine and cocaine metabolites, cannabinoids, phencyclidine, amphetamine, methamphetamine, opiates, barbiturates and methadone with the OraSure Technologies Intercept™ MICRO-PLATE EIAs.

The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device consists of a treated absorbent cotton fiber pad affixed to a nylon stick (Collection Pad) and a preservative solution in a plastic container (Specimen Vial). The Collection Pad is impregnated with a mixture of common salts and gelatin, creating a hypertonic environment which produces an osmotic gradient across the buccal and gingival mucosae. The Pad is placed in contact with the gingival mucosa (between the lower cheek and gum) which enhances the flow of mucosal transudate onto the absorptive cotton fibers of the Pad. Following the collection period, the Collection Pad is removed from the mouth and placed into a Specimen Vial. The vial contains a preservative solution which serves to inhibit the growth of oral microorganisms recovered on the Collection Pad. The vial is sealed with a plastic cap and transported to a laboratory for processing and testing.

This document pertains to the Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device. It is a collection device, so the performance criteria focuses on the ability to collect and preserve samples for subsequent drug testing, rather than direct diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list quantitative acceptance criteria for the device's performance in a table format, nor does it present specific performance data from a study.

However, the core of the submission (K011057) is a claim of substantial equivalence to a predicate device (OraSure® Oral Specimen Collection Device; K970357). The "performance" in this context is implicitly tied to demonstrating that the new device can effectively collect and preserve samples for the same range of drug detection as the predicate and extend this capability to additional drugs when paired with specific assays.

Implicit Acceptance Criteria (derived from the text):

2. Sample Size and Data Provenance for Test Set:

The provided 510(k) summary does not detail a specific "test set" sample size or data provenance for a direct clinical performance study of the collection device itself.

Instead, the submission relies on:

• Substantial Equivalence: By claiming substantial equivalence to the OraSure® Oral Specimen Collection Device (K970357), it implicitly asserts that the new device performs similarly for its core functions.
• Referenced PMA/510(k)s for Assays: For the extended detection capabilities, the document refers to multiple separate premarket notifications (K001197, K000399, K992918, K002375, K993208, K981341, K001976, K002010) for the OraSure Technologies Intercept™ MICRO-PLATE EIAs. The performance data for detecting the specific drugs with oral specimens collected by this device would be detailed within those referenced assay submissions.

Therefore, without access to those referenced documents, we cannot provide details on the test set sample size or data provenance for the drug detection capabilities.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

The document does not mention the use of experts to establish ground truth specifically for the collection device's performance in this 510(k) summary. This is consistent with a substantial equivalence claim for a collection device, where the focus is on physical and functional similarity to an already cleared device, and the analytical performance (e.g., drug detection accuracy) is tied to the separate assays.

4. Adjudication Method for Test Set:

Not applicable, as no direct "test set" and ground truth establishment by experts for the collection device itself is described.

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

Not applicable. The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device is a collection device, not an AI-assisted diagnostic tool or a device that requires human interpretation in the way an imaging AI might. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone Performance Study (Algorithm Only):

Not applicable. This device is a manual specimen collection device and does not involve an algorithm for standalone performance. Its "performance" is its ability to successfully collect and preserve an oral fluid specimen for laboratory analysis.

7. Type of Ground Truth Used:

For the collection device's core functionality, the "ground truth" is implied by its functional equivalence to the predicate device and its ability to deliver a specimen suitable for subsequent laboratory analysis.

For the drug detection claims, the ground truth would be established during the development and validation of the specific EIAs (Enzyme Immunoassays) as detailed in the referenced K numbers. This type of ground truth typically involves:

• Analytical Standards: Known concentrations of drugs and their metabolites.
• Spiked Samples: Oral fluid samples to which known amounts of drugs have been added.
• Clinical Samples with Confirmed Results: Oral fluid samples from actual subjects, where drug presence/absence and concentration have been independently confirmed by more definitive methods (e.g., GC/MS or LC/MS-MS, considered the gold standard for drug testing).

8. Sample Size for the Training Set:

The document does not specify a training set sample size. As a collection device, it does not typically involve traditional machine learning "training sets" in the same way an AI diagnostic algorithm would. Its design and functional validation would be based on engineering principles, materials science, and compatibility testing with chemical assays.

9. How Ground Truth for Training Set Was Established:

Not applicable, as a traditional "training set" with ground truth in the context of an algorithm or machine learning is not described or relevant for this type of device. The "ground truth" for the device's design and functionality would be based on:

• Established methods for oral fluid collection.
• Chemical stability validation for the preservative solution ensuring drug integrity.
• Compatibility testing with the OraSure Technologies Intercept™ MICRO-PLATE EIAs (which themselves would have their own established ground truth).

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