# K181305: OralTox Oral fluid Drug Test

- Pathway: 510(k) (Traditional)
- Applicant: Premier Biotech, Inc.
- Decided: Sep 20, 2018 after 126 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: 4 generations back to K924446 (1992). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171403: OralTox Oral Fluid Drug Test, Premier Biotech, Inc. (2018) Summary page 4.

## Most influential descendants
- K253705: Healgen® Accurate Oral Fluid Drug Test (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K181305
Methodology: https://510kreport.com/methodology