# K232604: LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Laihe Biotech Co., Ltd.
- Decided: Jan 10, 2024 after 135 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- 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: 7 generations back to K945610 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182123: ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card, Advin Biotech, Inc. (2019) Summary page 5.

## Indications for use
The LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi-Drug Test Kit (Cassette), and LYHER® Urine Multi-Drug Test Kit (Dipcard) are rapid lateral flow immunoassays for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Test Calibrator Cut-off (ng/mL) Amphetamine (AMP) d-Amphetamine 1000 Cocaine (COC) Benzoylecgonine 300 Marijuana (THC) 11-nor-A9-THC-9-COOH 50 Methamphetamine (MET) d-Methamphetamine 1000 Opiates(OPI) Morphine 2000 Phencyclidine (PCP) Phencyclidine 25 The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 6 analytes. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive positive 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/K232604
Methodology: https://510kreport.com/methodology