WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST

K121987 · Guangzhou Wondfo Biotech Co., Ltd. · DKZ · Aug 1, 2012 · Clinical Toxicology

Device Facts

• Record ID: K121987
• Device Name: WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Aug 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

Wondfo Amphetamine, Secobarbital, and Oxazepam Urine Tests are intended for the qualitative determination of d-Amphetamine , Secobarbital, and Oxazepam at a specific cut-off concentration in human urine samples. They are intended for healthcare professional use and over the counter use.

Device Story

Lateral flow immunochromatographic assay for qualitative detection of d-Amphetamine, Secobarbital, and Oxazepam in human urine; utilizes competitive binding principle with monoclonal antibody-dye conjugates and immobilized drug-protein conjugates on a membrane. Device formats include cup and dip card. Used in clinical or home settings by healthcare professionals or lay users. Urine sample is absorbed into the device via capillary action; analyte presence prevents antibody-dye conjugate binding to the test region, resulting in no colored band (positive result). Absence of analyte allows binding, producing a colored test line (negative result). Results are visual; intended for preliminary screening only; requires confirmatory testing via GC/MS. Benefits include rapid, point-of-care drug screening.

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 per drug. Lay-user studies conducted with 140 participants per drug format (cup/dip card) across diverse demographics, showing high agreement (85-100%) with GC/MS results across various concentrations relative to cut-offs.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Materials include monoclonal antibody-dye conjugates (gold chloride), drug-protein conjugates, and anti-mouse IgG polyclonal antibody on membranes. Form factors: cup and dip card. Stability: 4-30°C for 23 months. No electronic components or software algorithms.

Indications for Use

Indicated for qualitative detection of d-Amphetamine (1000ng/mL), Secobarbital (300ng/mL), and Oxazepam (300ng/mL) in human urine. Intended for prescription and OTC use. Provides preliminary results; requires confirmatory testing (GC/MS preferred).

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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Decision Summary, k121987

This 510(k) was reviewed under OIVD’s Pilot Triage 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.