SAFECARE® THC Urine Strip Test
Device Facts
| Record ID | K191924 |
|---|---|
| Device Name | SAFECARE® THC Urine Strip Test |
| Applicant | Safecare Biotech (Hangzhou) Co., Ltd. |
| Product Code | NFW · Clinical Toxicology |
| Decision Date | Aug 16, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3870 |
| Device Class | Class 2 |
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.
Indications for Use
Indicated for qualitative detection of Marijuana (11-nor-Δ9-THC-9 COOH) in human urine at 50 ng/mL cutoff. Intended for over-the-counter use by the general population.
Regulatory Classification
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).
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