Identifiers
- 510(k) Number
- K110182 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 cannabinoids and their metabolites in human urine. It employs a competitive binding, lateral flow immunochromatographic assay to identify 11-nor-Δ9-THC-9-COOH, a primary metabolite of THC, in urine samples. The test is designed for use in clinical toxicology settings to screen for recent cannabis use. Results are presented as a qualitative determination, indicating the presence or absence of cannabinoids above a specified cutoff level.
The Cannabinoids Urine Test is supplied as a cassette-format, single-use device with a cutoff of 50 ng/mL. It is intended for in vitro diagnostic use and requires no special storage conditions beyond those specified by the manufacturer. The device has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device (regulation number 862.3870). It is not intended for MRI use and must be handled in accordance with standard laboratory practices for urine testing.
Frequently asked questions
What is the Cannabinoids Urine Test used for?
The Cannabinoids Urine Test is designed for the qualitative detection of cannabinoids and their metabolites in human urine, specifically identifying 11-nor-Δ9-THC-9-COOH, the primary metabolite of THC. It is intended for use in clinical toxicology settings to screen for recent cannabis use. The test provides a quick, visual result indicating whether cannabinoids are present above a cutoff level of 50 ng/mL.
How is the Cannabinoids Urine Test supplied and how should it be stored?
The test is supplied as a single-use cassette-format device. It does not require special storage conditions beyond those recommended by the manufacturer. Standard laboratory storage practices for urine tests should be followed to maintain its integrity and performance.
Is the Cannabinoids Urine Test single-use or reusable?
The Cannabinoids Urine Test is explicitly designed for single-use only. Each cassette is intended for one test, ensuring accuracy and preventing cross-contamination. Reusing the device is not recommended and could compromise results.
What cutoff level does the Cannabinoids Urine Test use, and why is this important?
The test uses a cutoff level of 50 ng/mL for detecting cannabinoids. This cutoff determines the threshold concentration at which the test will indicate a positive result. The 50 ng/mL cutoff is a common standard in clinical toxicology for screening recent cannabis use, balancing sensitivity and specificity to minimize false positives or negatives.
Can the Cannabinoids Urine Test be used with MRI or other imaging equipment?
No, the Cannabinoids Urine Test is not intended for use with MRI or any other imaging equipment. It is strictly an in vitro diagnostic device for laboratory use, and its performance is not affected by or relevant to imaging modalities.
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. Sources consulted: CANNABINOIDS URINE TEST by Guangzhou Wondfo Biotech Co., Ltd. | FDA 510 ..., Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine Test, CANNABINOIDS URINE TEST (K110182) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110182 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
Sources (1)
- FDA 510(k) K110182 24 fields · synced Oct 5, 2026