CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids

K150179 · Guangzhou Wondfo Biotech Co., Ltd. · DJG · Feb 25, 2015 · Clinical Toxicology

Device Facts

• Record ID: K150179
• Device Name: CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Feb 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

CR3 Keyless Split Sample Cup Oxycodone-Cannabinoids is a rapid test for the qualitative detection of Oxycodone and Cannabinoids in human urine at a cutoff concentration of 100 ng/mL and 50 ng/mL, respectively. The test is the first step in a two-step process. The second step is to 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 test may yield preliminary positive results even when the prescription drug Oxycodone is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxycodone in urine. The CR3 Keyless Split Sample Cup Oxycodone-Cannabinoids 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

Lateral flow immunochromatographic assay for qualitative detection of Oxycodone and Cannabinoids in human urine; cup-based format. Principle: competitive binding; mouse monoclonal anti-drug antibody-dye conjugate binds to immobilized drug-protein conjugate on membrane. Negative result: colored line in Test Region (T) (analyte below cutoff). Positive result: no line in Test Region (analyte above cutoff). Control line (C) confirms proper flow. Used in clinical or home settings; operated by lay users or clinicians. Provides preliminary screening; positive results require laboratory confirmation via GC/MS. Assists in identifying potential drug presence to guide clinical decision-making or further diagnostic testing.

Clinical Evidence

No clinical studies performed. Evidence consists of bench testing: precision studies (3 operators, 25 days), analytical cut-off verification, interference testing (100+ compounds), specificity/cross-reactivity, and method comparison against GC/MS (80 clinical samples). Lay-user study (n=260) demonstrated 85-100% agreement with GC/MS across various concentrations and confirmed readability of instructions (Flesch-Kincaid grade <7).

Technological Characteristics

Lateral flow immunochromatographic assay. Components: mouse monoclonal anti-drug antibody-dye conjugate, fixed drug-protein conjugates, anti-mouse IgG polyclonal antibodies on membrane. Form factor: cup. No energy source required. Stability: 18 months at 4-30°C.

Indications for Use

Indicated for qualitative detection of Oxycodone (100 ng/mL) and Cannabinoids (50 ng/mL) in human urine. Intended for OTC and prescription use as a preliminary screening tool. Not intended to distinguish between prescription use and abuse. Requires confirmatory testing (GC/MS) for positive results.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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) #: k150179

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.