CR3 Keyless Split Sample Cup Morphine - Methamphetamine

K150602 · Guangzhou Wondfo Biotech Co., Ltd. · DNK · Apr 7, 2015 · Clinical Toxicology

Device Facts

• Record ID: K150602
• Device Name: CR3 Keyless Split Sample Cup Morphine - Methamphetamine
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DNK · Clinical Toxicology
• Decision Date: Apr 7, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3640
• Device Class: Class 2

Indications for Use

CR3 Keyless Split Sample 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, respectively. The test is the first step in a two-step process. The send the sample for laboratory testing if preliminary positive results are obtained. The test is intended for over-the-counter and for prescription use. The CR3 Keyless Split Sample 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.

Device Story

The CR3 Keyless Split Sample Cup is a lateral flow immunochromatographic assay for qualitative detection of Morphine and Methamphetamine in human urine. The device uses competitive binding; urine is absorbed into the cup via capillary action and mixes with antibody-dye conjugates. If drug concentration is below the cutoff, antibody-dye conjugates bind to immobilized drug-protein conjugates in the test region, producing a colored line (negative result). If drug concentration is above the cutoff, analyte molecules bind to the antibody-dye conjugate, preventing binding to the test region (positive result). A control line forms regardless of drug presence. The device is used by lay users (OTC) or clinicians (prescription) to obtain preliminary results. Positive results require follow-up laboratory confirmation via GC/MS. The device aids in initial drug screening, allowing for rapid assessment of potential drug presence.

Clinical Evidence

No clinical studies were performed. Evidence consists of analytical performance testing (precision, interference, specificity, stability, and effect of pH/specific gravity) and a lay-user study. Lay-user study (n=260) demonstrated 85-100% agreement with GC/MS across various concentrations near the cutoff. Analytical performance confirmed cutoff values of 300 ng/mL for Morphine and 1000 ng/mL for Methamphetamine.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Components include mouse monoclonal anti-drug antibody-dye conjugates, fixed drug-protein conjugates, and anti-mouse IgG polyclonal antibodies on test membranes. Form factor is a sample cup. Stable at 4-30°C for 18 months. No electronic components or software.

Indications for Use

Indicated for qualitative detection of Morphine and Methamphetamine in human urine at 300 ng/mL and 1000 ng/mL cutoffs, respectively. Intended for OTC and prescription use as a preliminary screening tool. Requires confirmatory testing (e.g., GC/MS) for positive results.

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) #: k150602

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.