(126 days)
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:
| Test | Calibrator | Cutoff (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 50 |
| Cocaine (COC) | Benzoylecgonine | 20 |
| Marijuana (THC) | Delta-9-Tetrahydrocannabinol | 40 |
| Methamphetamine (MET) | d-Methamphetamine | 50 |
| Opiates (OPI) | Morphine | 40 |
| Phencyclidine (PCP) | Phencyclidine | 10 |
| Oxycodone (OXY) | Oxycodone | 20 |
| Methadone (MTD) | Methadone | 30 |
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)
| Test | Calibrator | Cutoff (ng/mL) | Acceptance Criteria (Implied) | Reported Device Performance (for Methadone and Oxycodone) |
|---|---|---|---|---|
| Methadone (MTD) | Methadone | 30 | Precision/Reproducibility: Consistent results across multiple runs and lots, especially around the cutoff. | Precision-Reproducibility-Cut-Off: |
- Lot 1 (Methadone):
-100% to -50% cut-off: 60-/0+ (100% negative)
-25% cut-off: 54-/6+ (90% negative, 10% positive)
Cut-off: 49+/11- (81.7% positive, 18.3% negative)
+25% to +100% cut-off: 55+/5- (91.7% positive), 60+/0- (100% positive) - Lot 2 (Methadone): Similar performance, with 55-/5+ at -25% cut-off and 48+/12- at cut-off.
- Lot 3 (Methadone): Similar performance, with 55-/5+ at -25% cut-off and 50+/10- at cut-off.
Method Comparison (Methadone):
- Drug Free &
§ 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).