EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine

K151557 · Nantong Egens Biotech Co., Ltd. · DNK · Jul 16, 2015 · Clinical Toxicology

Device Facts

• Record ID: K151557
• Device Name: EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine
• Applicant: Nantong Egens Biotech Co., Ltd.
• Product Code: DNK · Clinical Toxicology
• Decision Date: Jul 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3640
• Device Class: Class 2

Indications for Use

The EGENS Urine Test Cup Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively. EGENS Urine Test Cup Morphine - Methamphetamine 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. The EGENS Urine Test DipCard Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively. EGENS Urine Test DipCard Morphine - Methamphetamine 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 Morphine and Methamphetamine in human urine; competitive binding principle using monoclonal mouse antibodies. Urine specimen migrates via capillary action; target drugs below cutoff do not saturate antibody binding sites, allowing formation of visible colored test line; target drugs above cutoff saturate binding sites, preventing test line formation. Control line indicates proper test performance. Used in home (OTC) or clinical settings; operated by lay users or healthcare professionals. Provides preliminary results; positive results require confirmation via GC/MS. Aids in identifying potential drug use; clinical judgment required for interpretation.

Clinical Evidence

Bench testing only. Precision studies (3 operators, 25 days) and cutoff verification (125 samples per drug) demonstrated consistent performance. Interference and specificity studies confirmed no cross-reactivity with common substances. Method comparison against GC/MS showed high agreement. Lay-user study (n=560) confirmed ease of use and performance across diverse demographics.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding; monoclonal mouse antibodies. Formats: Cup and DipCard. No electronic components or software. Stable at 4-30°C for 24 months.

Indications for Use

Indicated for qualitative detection of Morphine (300 ng/mL cutoff) and Methamphetamine (1000 ng/mL cutoff) in human urine. Intended for over-the-counter and prescription use by lay users and clinicians for preliminary screening. Requires confirmatory testing (GC/MS).

Regulatory Classification

Identification

A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A morphine 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) #: k151557

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.