WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)

K132630 · Guangzhou Wondfo Biotech Co., Ltd. · DJC · Sep 27, 2013 · Clinical Toxicology

Device Facts

• Record ID: K132630
• Device Name: WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DJC · Clinical Toxicology
• Decision Date: Sep 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Indications for Use

Wondfo Methamphetamine Urine Test (MET 300) is an immunochromatographic assay for the qualitative determination of D(+)-Methamphetamine in human urine at a Cut-Off concentration of 300 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 Oxazepam Urine Test (BZO 200) is an immunochromatographic assay for the qualitative determination of Oxazepam in human urine at a Cut-Off concentration of 200 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 D(+)-Methamphetamine and Oxazepam in human urine. Device formats include Dip Card and Cup. Principle: competitive binding; urine sample migrates via capillary action across membrane pre-coated with drug-protein conjugates; antibody-dye conjugate binds to target analyte if present. Absence of colored test line indicates positive result; presence indicates negative result. Used in clinical settings by professionals; not for point-of-care. Provides preliminary results requiring GC/MS confirmation. Assists healthcare providers in identifying drug presence to inform clinical decision-making.

Clinical Evidence

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

Technological Characteristics

Lateral flow immunochromatographic assay. Components: monoclonal antibody-dye conjugate, gold chloride, drug-protein conjugates, anti-mouse IgG polyclonal antibody. Formats: Dip Card and Cup. Stable at 4-30°C for 18 months. No electronic components or software.

Indications for Use

Indicated for the qualitative detection of D(+)-Methamphetamine (300 ng/mL cutoff) or Oxazepam (200 ng/mL cutoff) in human urine. Intended for prescription use only; not for point-of-care use. Requires confirmatory testing via GC/MS.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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) #: k132630

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.