WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)

K131754 · Guangzhou Wondfo Biotech Co., Ltd. · DIO · Jul 31, 2013 · Clinical Toxicology

Device Facts

• Record ID: K131754
• Device Name: WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Jul 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Indications for Use

Wondfo Cocaine Urine Test (COC 100) is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. 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. Wondfo Cannabinoids Urine Test (THC 40) is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a Cut-Off concentration of 40 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. 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.

Device Story

Lateral flow immunochromatographic assay for qualitative detection of Benzoylecgonine and 11-nor-Δ9-THC-9-COOH in human urine. Device uses monoclonal antibody-dye conjugate, gold chloride, and fixed drug-protein conjugates on membrane. Urine sample absorbed via capillary action; competitive binding principle: analyte below cutoff allows antibody-dye to bind immobilized drug-protein (colored line, negative); analyte above cutoff binds antibody-dye, preventing line formation (positive). Available in Dip Card and Cup formats. Used in clinical settings by professionals; provides preliminary results requiring GC/MS confirmation. Assists clinicians in drug abuse screening.

Clinical Evidence

Bench testing only. Precision studies performed over 25 days. Specificity and interference testing conducted with various physiological/pathological compounds. Method comparison performed in-house using 80 clinical samples (40 positive, 40 negative) compared to GC/MS reference method.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: monoclonal antibody-dye conjugate, gold chloride, fixed drug-protein conjugates, anti-mouse IgG polyclonal antibody on membrane. Form factors: Dip Card and Cup. Storage: 4-30°C. No electronic components or software.

Indications for Use

Indicated for qualitative detection of Benzoylecgonine (100 ng/mL cutoff) or 11-nor-Δ9-THC-9-COOH (40 ng/mL cutoff) in human urine. Intended for prescription use only; not for point-of-care use. Requires confirmatory testing (e.g., GC/MS).

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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) #: k131754

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.