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The Oratect Oral fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME), Delta-9-Tetrahydrocannabinol (TH), Cocaine (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The Oratect tests detect these drugs at the cutoff concentration listed below.

These products are for in vitro diagnostic use and intended for prescription point of care use.

The Orated® Oral Fluid Drug Screen Device provides only preliminary drug test results. A more specific alternative 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. Samples for confirmatory testing should be collected with the Oratect® Oral Fluid Collection Tube (50 mL polypropylene tube) provided. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

OratectCheck™ Oral Fluid Controls (Negative and Positive controls of the analytes) are available but not supplied with the Oratect Oral Fluid Drug Screen Devices. The OratectCheck™ Oral Fluid Controls are used as quality control materials with Oratect® Oral Fluid Drug Screen Devices.

The Oratect® Oral Fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME), Delta-9-Tetrahydrocannabinol (TH), Cocaine (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The test principle is a competitive lateral flow immunochromatographic assay. The presence of analyte will produce a negative signal.

Acceptance Criteria and Device Performance for Oratect® Oral Fluid Drug Screen Devices

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in the provided document. However, the document consistently uses "Accuracy results against reference method >90%" as the performance metric for the subject device and "Accuracy results against reference method >89%" for the predicate. For the purpose of this summary, we will infer the acceptance criterion to be >90% accuracy against a reference method.

The reported device performance based on the "Accuracy" row in the comparison table is also >90% against reference method.

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

The document mentions "analytical performance validation studies, precision site studies and in method comparison studies".

• Sample Size: The document does not explicitly state the total sample size used for the test set in the "method comparison studies." It mentions "three (3) Point of Care (POC) sites" for the precision study, but not the number of samples at each site or for the overall accuracy study.
• Data Provenance: The data provenance is not explicitly stated (e.g., country of origin, specific demographics). The studies are referred to as "analytical" and "clinical" performance tests, implying human samples were involved. It is likely retrospective data collected for validation, as no prospective clinical trial details are provided.

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

The document does not provide details on the number of experts or their qualifications used to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided text. The study primarily focuses on comparing the subject device's performance against reference laboratory methods (LC/MS or GC/MS) and its predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

The device itself, the "Oratect® Oral Fluid Drug Screen Device," is a standalone immunoassay device. The performance described (accuracy, precision, specificity) is inherently its standalone, algorithm-only (or device-only) performance, as it produces a visually interpreted result without human-in-the-loop assistance beyond the interpretation of the test lines.

7. Type of Ground Truth Used

The ground truth used for the comparison studies was established by "LC/MS or GC/MS reference test method." These are highly specific and quantitative laboratory methods considered the definitive gold standard for drug detection.

8. Sample Size for the Training Set

The document does not provide information regarding a "training set" or its sample size. Immunoassay devices like the Oratect® generally do not involve machine learning algorithms that require a distinct training set in the typical sense. Their performance is validated through analytical and clinical studies as described.

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

Since there is no mention of a "training set" in the context of machine learning, there is no information on how a ground truth for such a set was established. The performance validation relies on comparing the device's results to established reference methods (LC/MS or GC/MS) for individual samples.

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