BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip

K192301 · Shenzhen Bioeasy Biotechnology Co., Ltd. · NFW · Sep 20, 2019 · Clinical Toxicology

Device Facts

• Record ID: K192301
• Device Name: BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
• Applicant: Shenzhen Bioeasy Biotechnology Co., Ltd.
• Product Code: NFW · Clinical Toxicology
• Decision Date: Sep 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Indications for Use

BIOEASY Marijuana Test Dip Card is 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 method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. BIOEASY Marijuana Test Strip is 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 method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

Device Story

Lateral flow immunochromatographic assay for qualitative detection of Marijuana (11-Nor-Δ9-THC-9-COOH) in human urine; 50 ng/mL cutoff. Urine sample migrates via capillary action; competitive binding mechanism uses monoclonal mouse antibodies coated on particles. If drug concentration is below cutoff, antibody-coated particles bind to immobilized drug-conjugate, forming visible colored test line. If drug concentration exceeds cutoff, binding sites are saturated, preventing test line formation. Control line confirms proper test performance. Used in home or point-of-care settings by lay users; results interpreted visually by user. Provides preliminary screening; requires confirmatory testing by GC/MS or LC/MS for clinical decision-making. Benefits include rapid, accessible preliminary detection of marijuana use.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies, interference testing, specificity/cross-reactivity, and method comparison against LC/MS. Lay-user study (n=280) across diverse demographics confirmed ease of use and accuracy; results showed high concordance with LC/MS across concentrations relative to the 50 ng/mL cutoff. No clinical studies performed.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Single-use test device in aluminum pouch with desiccant. Analyte: 11-Nor-Δ9-THC-9-COOH. Cutoff: 50 ng/mL. Visual readout. No electronic components or software.

Indications for Use

Indicated for qualitative detection of Marijuana in human urine at 50 ng/mL cutoff. Intended for over-the-counter use. Provides preliminary results; requires confirmatory testing via GC/MS or LC/MS.

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).

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: k192301

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.