CR3 Keyless Split Sample Cup Secobarbital- Methadone

K143535 · Guangzhou Wondfo Biotech Co., Ltd. · DIS · Jan 13, 2015 · Clinical Toxicology

Device Facts

• Record ID: K143535
• Device Name: CR3 Keyless Split Sample Cup Secobarbital- Methadone
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DIS · Clinical Toxicology
• Decision Date: Jan 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3150
• Device Class: Class 2

Indications for Use

CR3 Keyless Split Sample Cup Secobarbital-Methadone is a rapid test for the qualitative detection of Secobarbital and Methadone in human urine at a cutoff concentration of 300ng/mL for each of the drugs. The test may yield preliminary positive results when prescription drugs Secobarbital and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital and Methadone in urine. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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 Secobarbital and Methadone in human urine; competitive binding principle. Device consists of sample cup containing test membranes pre-coated with drug-protein conjugates and mouse monoclonal anti-drug antibody-dye conjugates. User immerses absorbent end in urine; capillary action draws sample across membrane. Analyte below cutoff allows antibody-dye to bind to test line (negative); analyte above cutoff binds antibody-dye, preventing test line formation (positive). Control line confirms proper flow. Used in point-of-care or home settings by lay users or clinicians. Preliminary positive results require confirmation via GC/MS. Benefits include rapid, on-site screening for drug presence to inform clinical or personal decision-making.

Clinical Evidence

Bench testing only. Precision studies (n=50 per concentration level) across 25 days confirmed performance at cutoffs. Interference testing evaluated 100+ compounds. Method comparison against GC/MS performed with 80 clinical samples. Lay-user study (n=260) demonstrated 80-100% agreement with GC/MS across various concentrations near cutoff. Flesch-Kincaid reading grade level <7 for instructions.

Technological Characteristics

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

Indications for Use

Indicated for qualitative detection of Secobarbital and Methadone in human urine at 300ng/mL cutoff. Intended for OTC and prescription use to provide preliminary results requiring confirmation by GC/MS.

Regulatory Classification

Identification

A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A barbiturate 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)

{0}

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k143535

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.