# K240287: LYHER® Oral fluid Multi-Drug Test Kit (Cube)

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Laihe Biotech Co., Ltd.
- Decided: Mar 18, 2025 after 411 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.
No later device cites it as a predicate yet.
0 of 10 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 5.

## Indications for use
The LYHER® Oral fluid Multi-Drug Test Kit (Cube) is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocannabinol in human oral fluid. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Test Calibrator Cut-off (ng/mL) Opiates(OPI) Morphine 40 Cocaine (COC) Benzoylecgonine 20 Amphetamine (AMP) d-Amphetamine 50 Marijuana (THC) Delta-9-Tetrahydrocannabinol 40 Methamphetamine (MET) d-Methamphetamine 50 Phencyclidine (PCP) Phencyclidine 10 The single or multi-test panels can consist of the above listed analytes in anycombination, up to a maximum of 6 analytes. The tests provide only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test result. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

Source page: https://510kreport.com/device/K240287
Methodology: https://510kreport.com/methodology