# K252523: Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test

- Pathway: 510(k) (Traditional)
- Applicant: Healgen Scientific,, LLC
- Decided: Feb 12, 2026 after 185 days
- Product code: NFW (Test, Cannabinoid, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.3870
- 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 K923386 (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)
- K223162: Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT, Healgen Scientific,, LLC (2023) Summary page 5.

## Indications for use
The Healgen® Accurate Oral Fluid Drug Test COT/THC is a lateral flow chromatographic immunoassay for the qualitative detection of cotinine (COT) and/or marijuana (THC) in oral fluid at the following cut-off concentrations: Test Calibrator Cut-off (ng/mL) Cotinine (COT) (-) Cotinine 30 Marijuana (THC) Delta-9-Tetrahydrocannabinol 40 This test provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Liquid chromatography mass spectrometry (LC/MS) is the preferred method for the confirmation test. The Healgen® Accurate Oral Fluid Drug Test is a competitive binding lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Marijuana (THC) and Cotinine in human oral fluid at the cutoff concentrations listed below and their metabolites: Test Calibrator Cut-off (ng/mL) Cotinine (COT) (-) Cotinine 30 Marijuana (THC) Delta-9-Tetrahydrocannabinol 40 This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography mass spectrometry (GC/MS) and liquid chromatography mass spectrometry (LC/MS) are the preferred confirmatory methods.

Source page: https://510kreport.com/device/K252523
Methodology: https://510kreport.com/methodology