SAFECare THC Urine Strip Test
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191924 FDA 510(k)
- FDA Product Code
- NFW 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)
The SAFECare THC Urine Strip Test is a competitive binding, lateral flow immunochromatographic assay designed for the qualitative detection of tetrahydrocannabinol (THC) metabolites in human urine. It functions as a point-of-care diagnostic tool to identify the presence of marijuana use at a cutoff concentration of 50 ng/mL, providing preliminary results for screening purposes.
This single-use, over-the-counter device is intended for use in clinical toxicology settings, such as drug testing programs or medical evaluations. Supplied as a strip-based assay, it requires no special storage conditions beyond room temperature and is classified as a Class II medical device under FDA regulations (K191924, NFW). Results are preliminary and must be confirmed with additional testing for definitive diagnosis.
Frequently asked questions
What is the SAFECare THC Urine Strip Test used for?
This device is designed for the qualitative detection of tetrahydrocannabinol (THC) metabolites in human urine, specifically to screen for marijuana use. It provides preliminary results at a cutoff concentration of 50 ng/mL, making it useful in clinical toxicology settings such as drug testing programs or medical evaluations. Results are not definitive and require confirmation with additional testing.
How is the SAFECare THC Urine Strip Test supplied and stored?
The test is supplied as a single-use, strip-based assay. No special storage conditions are required—it can be stored at room temperature. This makes it convenient for point-of-care use without the need for refrigeration or complex handling.
Is the SAFECare THC Urine Strip Test sterile and single-use?
Yes, the SAFECare THC Urine Strip Test is a single-use device, meaning each strip is intended for one test only. While the device itself is not explicitly described as sterile in the provided data, its design as a lateral flow assay and single-use application aligns with typical practices for minimizing contamination risk in point-of-care diagnostics.
What are the regulatory details for this device?
The SAFECare THC Urine Strip Test is classified as a Class II medical device under FDA regulations and has received 510(k) clearance (K191924). It was reviewed by the FDA’s Clinical Toxicology Advisory Committee and is intended for over-the-counter use. The device falls under the product code NFW and regulation number 862.3870.
Why are the results from this test considered preliminary?
The SAFECare THC Urine Strip Test uses a competitive binding, lateral flow immunochromatographic assay to detect THC metabolites, which provides a rapid and convenient screening result. However, immunochromatographic assays can produce false positives or negatives due to factors like cross-reactivity with other substances or variations in metabolite levels. For this reason, results are considered preliminary and must be confirmed with further testing to ensure accuracy.
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: Safecare Antigen Selbsttest günstig online kaufen | medplus, SAFECARE® THC Urine Strip Test (K191924) — FDA 510 (k) | Innolitics, Safecare Coronatest – Zuverlässige COVID-19 Schnelltests online …, SAFECARE® THC Urine Strip Test 510 (k) K191924 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191924 | Class II | Active |
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Manufacturer
- Manufacturer
- Safecare Biotech (Hangzhou) Co., Ltd.
Sources (1)
- FDA 510(k) K191924 24 fields · synced Oct 5, 2026