# K253705: Healgen® Accurate Oral Fluid Drug Test

- Pathway: 510(k) (Traditional)
- Applicant: Healgen Scientific,, LLC
- Decided: Mar 16, 2026 after 112 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: 5 generations back to K924446 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181305: OralTox Oral fluid Drug Test, Premier Biotech, Inc. (2018) Summary page 5.

## Indications for use
The Healgen® Accurate Oral Fluid Drug Test is a competitive binding lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Methadone, Methamphetamine, Opiates, Oxycodone, 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 Methadone (MTD) Methadone 30 Methamphetamine (MET) d-Methamphetamine 50 Opiates (OPI) Morphine 40 Oxycodone (OXY) Oxycodone 20 Phencyclidine (PCP) Phencyclidine 10 The test provides only preliminary test results. A more specific alternative chemical method must be used 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 distinguish between prescription use or abuse of the drug. 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/K253705
Methodology: https://510kreport.com/methodology