WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)

K131232 · Guangzhou Wondfo Biotech Co., Ltd. · DJR · May 31, 2013 · Clinical Toxicology

Device Facts

• Record ID: K131232
• Device Name: WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DJR · Clinical Toxicology
• Decision Date: May 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Indications for Use

Wondfo Methadone Urine Test (MTD 200) is an immunochromatographic assay for the qualitative determination of Methadone 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. Wondfo Morphine Urine Test (MOP 100) is an immunochromatographic assay for the qualitative determination of Morphine 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.

Device Story

Lateral flow immunochromatographic assay for qualitative detection of Methadone or Morphine in human urine; utilizes competitive binding principle. Device consists of absorbent end, monoclonal antibody-dye conjugate, and pre-coated membrane with drug-protein conjugates. Urine sample migrates via capillary action; analyte below cut-off binds to immobilized drug-protein conjugate in test region (colored line = negative); analyte above cut-off binds to antibody-dye conjugate (no line = positive). Available in Dip Card or Cup formats. Used in clinical/laboratory settings by professional staff. Provides preliminary results to assist clinical decision-making; requires confirmatory testing via GC/MS. Benefits include rapid screening for drug presence.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (25 days, two runs/day) and method comparison against GC/MS using 80 clinical samples. Results demonstrated concordance with GC/MS. Interference and specificity tested against numerous physiological/pathological compounds; no interference observed. Stability confirmed for 18 months at 4-30°C.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Materials: monoclonal antibody-dye conjugate, gold chloride, drug-protein conjugates, anti-mouse IgG polyclonal antibody. Formats: Dip Card and Cup. Standalone device; no energy source required. Visual readout.

Indications for Use

Indicated for qualitative detection of Methadone (200 ng/mL) or Morphine (100 ng/mL) in human urine. Intended for prescription use only; not for point-of-care use. Provides preliminary results requiring GC/MS confirmation.

Regulatory Classification

Identification

A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

Special Controls

*Classification.* Class II (special controls). A methadone 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) #: k131232

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.