← Product Code [NFW](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NFW) · K191924 # SAFECARE® THC Urine Strip Test (K191924) _Safecare Biotech (Hangzhou) Co., Ltd. · NFW · Aug 16, 2019 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NFW/K191924 ## Device Facts - **Applicant:** Safecare Biotech (Hangzhou) Co., Ltd. - **Product Code:** [NFW](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NFW.md) - **Decision Date:** Aug 16, 2019 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3870 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use SAFECARE® THC Urine Strip Test is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The test is intended for over-the-counter use. ## Device Story Single-use lateral flow immunochromatographic assay; detects 11-nor-Δ9-THC-9 COOH in human urine. Principle: competitive binding; urine migrates via capillary action; target drug competes with drug-conjugate for limited antibody-coated particle binding sites. Output: visual colored line in test region (negative result) or absence of line (positive result); control line confirms test validity. Used in home/point-of-care settings by lay users. Provides preliminary results; requires confirmatory testing (GC/MS or LC/MS) for clinical decision-making. Benefits: rapid, accessible screening for marijuana metabolites. ## Clinical Evidence Bench testing only. Precision studies verified 50 ng/mL cutoff over 25 days. Interference testing confirmed no cross-reactivity with numerous physiological/pathological substances at 100µg/mL. Specificity testing evaluated cross-reactivity with THC metabolites. Method comparison study (n=80 clinical samples) showed high concordance with LC/MS. Lay-user study (n=140) demonstrated 90-100% accuracy across various concentrations relative to LC/MS, confirming ease of use and performance in intended user population. ## Technological Characteristics Lateral flow immunochromatographic assay; competitive binding principle. Uses monoclonal mouse antibody-coated particles. Form factor: test strip. Storage: 4-30°C. No electronic components, energy source, or software. Materials: standard immunochromatographic test strip components. ## Regulatory Identification A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use. ## Special Controls *Classification.* Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. 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Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination. --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NFW/K191924](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NFW/K191924) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com