EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana

K152643 · Nantong Egens Biotech Co., Ltd. · LDJ · Nov 2, 2015 · Clinical Toxicology

Device Facts

• Record ID: K152643
• Device Name: EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana
• Applicant: Nantong Egens Biotech Co., Ltd.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Nov 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Indications for Use

EGENS Urine Test Marijuana (THC) is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL. The tests are available in a Cassette format, a Cup format and a Dip Card format. EGENS Urine Test Marijuana (THC) 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 is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use. EGENS Urine Test MDMA is a rapid for the qualitative test detection of Methylenedioxymethamphetamine in human urine at a cutoff concentration of 500 ng/mL. The tests are available in a Cup format and a Dip Card format. EGENS Urine Test MDMA 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 is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

Device Story

Lateral flow immunochromatographic assay for qualitative detection of THC and MDMA in human urine; competitive binding principle using monoclonal mouse antibodies. Urine sample migrates via capillary action; target drug competes with drug-conjugate for antibody binding sites. Visible colored line indicates negative result (drug below cutoff); absence of line indicates positive result (drug above cutoff). Used in point-of-care or home settings by lay users or clinicians. Provides preliminary screening results; positive results require confirmatory testing via GC/MS. Assists healthcare providers in identifying potential substance use, necessitating clinical judgment for final decision-making.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical performance (precision, interference, specificity, pH/specific gravity effects) and a lay-user study (n=700). Lay-user study demonstrated high agreement with GC/MS results across various concentrations (-75% to +75% of cutoff). Analytical testing confirmed performance across three lots and three operators.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: Cup, Cassette, DipCard. Analyte-specific monoclonal mouse antibodies. No electronic components; non-powered. Stability: 4-30°C for 24 months.

Indications for Use

Indicated for qualitative detection of Cannabinoids (50 ng/mL) and Methylenedioxymethamphetamine (500 ng/mL) in human urine. Intended for over-the-counter and prescription use in individuals requiring drug screening. Preliminary results only; requires confirmation by GC/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 MEMORANDUM

510(k) #: k152643

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.