# K171403: OralTox Oral Fluid Drug Test

- Pathway: 510(k) (Traditional)
- Applicant: Premier Biotech, Inc.
- Decided: Feb 2, 2018 after 266 days
- Product code: DJC (Thin Layer Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K924446 (1992). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103227: Oratect Oral Fluid Drug Screen Devices, Branan Medical Corporation (2012) Summary page 4.

## Most influential descendants
- K181305: OralTox Oral fluid Drug Test (2018), 1 descendant of its own
- K253705: Healgen® Accurate Oral Fluid Drug Test (2026), 0 descendants of its own
- K240287: LYHER® Oral fluid Multi-Drug Test Kit (Cube) (2025), 0 descendants of its own

## Indications for use
The OralTox 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, 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.

Source page: https://510kreport.com/device/K171403
Methodology: https://510kreport.com/methodology