CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE

K141532 · Guangzhou Wondfo Biotech Co., Ltd. · DKZ · Jul 14, 2014 · Clinical Toxicology

Device Facts

• Record ID: K141532
• Device Name: CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Jul 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

CR3 Keyless Split Sample Cup Amphetamine-Cocaine is a rapid test for the qualitative detection of d-Amphetamine (major metabolite of Amphetamine) and Benzoylecgonine (major metabolite of Cocaine) in human urine at a cutoff concentration of 1000ng/mL and 300ng/mL, respectively. 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 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. It is intended for over-the-counter and for prescription use.

Device Story

CR3 Keyless Split Sample Cup is a lateral flow immunochromatographic assay for qualitative detection of d-Amphetamine and Benzoylecgonine in human urine. Device uses competitive binding principle; mouse monoclonal anti-drug antibody-dye conjugates, fixed drug-protein conjugates, and anti-mouse IgG polyclonal antibodies are coated on test membranes. Urine sample is absorbed via capillary action; if analyte concentration is below cutoff, antibody-dye conjugates bind to immobilized drug-protein conjugates in Test Region (T), producing a colored line (negative result). If analyte is above cutoff, analyte binds to antibody-dye conjugate, preventing binding to Test Region (no colored line, positive result). Control line (C) forms regardless of drug presence. Device is used by lay users (OTC) or clinicians (prescription) to obtain preliminary drug screening results. Results require professional judgment and confirmatory testing via GC/MS. Benefits include rapid, point-of-care screening for drug metabolites.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (25 days, two runs/day), analytical specificity (cross-reactivity with metabolites/related compounds), and interference testing (physiological/pathological substances). Method comparison study performed with 80 clinical samples against GC/MS. Lay-user study conducted with 260 participants (diverse backgrounds, ages 21->50) across three sites, demonstrating high accuracy and agreement with GC/MS. Flesch-Kincaid reading grade level for package inserts was <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 test membranes. Form factor: split sample cup. Connectivity: none. Energy source: none (capillary action). Stability: 4-30°C for 18 months.

Indications for Use

Indicated for qualitative detection of d-Amphetamine and Benzoylecgonine in human urine for OTC and prescription use. Cutoff concentrations: 1000ng/mL for Amphetamine, 300ng/mL for Cocaine. Provides preliminary results only; requires GC/MS confirmation.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine 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) #: k141532

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.