LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Tes…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K232604 FDA 510(k)
- FDA Product Code
- LDJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3870 FDA 510(k)
- Regulation Number
- 862.3870 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an enzyme immunoassay for the qualitative detection of tetrahydrocannabinol (THC) and its metabolites in urine. It functions as a rapid, point-of-care diagnostic tool to identify recent cannabis use, aiding clinical toxicology assessments by providing qualitative results for THC presence within specified cut-off thresholds.
The kits are supplied as single-use, non-sterile test strips and cassette formats for immediate visual interpretation. They are classified as Class II devices under FDA regulations, with FDA 510(k) clearance and compliance with the In Vitro Diagnostic Device Regulations (IVDR). Storage requires protection from extreme temperatures and moisture, and results are intended for use in clinical toxicology settings, such as emergency departments or forensic laboratories.
Frequently asked questions
What clinical scenarios would this test kit be most useful for and why?
This test kit is designed for clinical toxicology assessments, particularly in settings like emergency departments or forensic laboratories where rapid detection of recent cannabis use is required. It helps clinicians quickly identify the presence of tetrahydrocannabinol (THC) and its metabolites in urine, aiding in patient evaluation for drug-related symptoms, trauma cases, or forensic investigations where cannabis exposure may be relevant.
Are the test strips and cassettes single-use only, and if so, why?
Yes, the LYHER® Urine Marijuana (THC) Test Kits are supplied as single-use devices. This design choice ensures accuracy and reliability, as reuse could introduce contamination or degradation of the test components, potentially leading to false results. Single-use also aligns with point-of-care testing best practices, where each test is intended for one-time use on a single urine sample.
How should I store these test kits to maintain their integrity, and why is this important?
The kits must be stored protected from extreme temperatures and moisture. Proper storage is critical because exposure to heat, cold, or humidity can compromise the stability of the reagents within the strips or cassettes, leading to inaccurate or unreliable test results. Following these storage guidelines ensures the test performs as intended when used.
What are the key differences between the strip and cassette formats of this test kit?
Both formats detect THC and its metabolites in urine using enzyme immunoassay technology, but they differ in presentation and ease of use. The strip format is typically simpler and faster for basic visual interpretation, while the cassette format may offer clearer, more defined results due to its enclosed design, which can reduce user error from environmental factors like light or handling. The choice between formats may depend on workflow preferences and the need for result clarity in your clinical setting.
What regulatory pathways has this device undergone, and what does that mean for its use in clinical settings?
The LYHER® Urine Marijuana (THC) Test Kit has undergone FDA 510(k) clearance and complies with In Vitro Diagnostic Device Regulations (IVDR). This means the device has been evaluated for safety, performance, and equivalence to predicate devices, ensuring it meets regulatory standards for use in clinical toxicology. Clinicians can rely on its compliance with these frameworks when integrating it into their diagnostic workflows.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K232604 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Laihe Biotech Co., Ltd.
Sources (2)
- FDA 510(k) K232604 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026