(266 days)
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:
| Test | Calibrator | Cutoff (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 50 |
| Cocaine (COC) | Benzoylecgonine | 20 |
| Marijuana (THC) | Delta-9 Tetrahydrocannabinol | 40 |
| Methamphetamine (MET) | d-Methamphetamine | 40 |
| Opiates (OPI) | Morphine | 40 |
| Phencyclidine (PCP) | Phencyclidine | 10 |
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:
| Drug | Concentration Range (by LC-MS/MS) | Number of Samples | Test Results (No. Positive / No. Negative) | Percentage of Correct Results (%) |
|---|---|---|---|---|
| Methamphetamine | Drug-Free | 324 | 0 / 324 | 100 |
| Less than Half the Cutoff | 50 | 0 / 50 | 100 | |
| Near Cutoff Negative | 15 | 2 / 13 | 87 | |
| Near Cutoff Positive | 16 | 15 / 1 | 94 | |
| High Positive | 116 | 116 / 0 | 100 | |
| Cocaine | Drug-Free | 390 | 0 / 390 | 100 |
| Less than Half the Cutoff | 21 | 0 / 21 | 100 | |
| Near Cutoff Negative | 19 | 1 / 18 | 95 | |
| Near Cutoff Positive | 15 | 14 / 1 | 93 | |
| High Positive | 77 | 77 / 0 | 100 | |
| Morphine | Drug-Free | 323 | 0 / 323 | 100 |
| Less than Half the Cutoff | 50 | 0 / 50 | 100 | |
| Near Cutoff Negative | 16 | 2 / 14 | 88 | |
| Near Cutoff Positive | 19 | 18 / 1 | 95 | |
| High Positive | 114 | 114 / 0 | 100 | |
| Amphetamine | Drug-Free | 229 | 0 / 229 | 100 |
| Less than Half the Cutoff | 92 | 0 / 92 | 100 | |
| Near Cutoff Negative | 61 | 2 / 59 | 97 | |
| Near Cutoff Positive | 39 | 36 / 3 | 92 | |
| High Positive | 17 | 17 / 0 | 100 | |
| Phencyclidine | Drug-Free | 407 | 0 / 407 | 100 |
| Less than Half the Cutoff | 20 | 0 / 20 | 100 | |
| Near Cutoff Negative | 8 | 2 / 6 | 75 | |
| Near Cutoff Positive | 4 | 4 / 0 | 100 | |
| High Positive | 38 | 38 / 0 | 100 | |
| Cannabinoids | Drug-Free | 359 | 0 / 327 (Error in doc for Negative count, assumed 359) | 100 |
| Less than Half the Cutoff | 27 | 0 / 27 | 100 | |
| Near Cutoff Negative | 7 | 0 / 7 | 100 | |
| Near Cutoff Positive | 9 | 6 / 3 | 67 | |
| High Positive | 20 | 20 / 0 | 100 |
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.
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).