ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
Device Facts
| Record ID | K130055 |
|---|---|
| Device Name | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Feb 14, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
Wondfo Buprenorphine Urine Test is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at a cutoff concentration of 10 ng/mL. The test is available in a dip card format and a cup format. It is intended for over the counter use. The Buprenorphine assay will yield preliminary positive results when Buprenorphine is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for buprenorphine in urine. The Wondfo Buprenorphine Urine Test shows the drug was or was not present at the cutoff level. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GC/MS or LC/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. The device does not differentiate between drug abuse and prescription use of buprenorphine.
Device Story
Wondfo Buprenorphine Urine Test is a lateral flow, one-step immunochromatographic assay for qualitative Buprenorphine detection in human urine. The device uses monoclonal antibody-dye conjugates with gold chloride, fixed drug-protein conjugates, and anti-mouse IgG polyclonal antibodies on a membrane. The user immerses the dip card or cup into a urine sample; capillary action draws the sample across the membrane. If Buprenorphine is below the 10 ng/mL cutoff, antibody-dye conjugates bind to the immobilized drug-protein conjugate, creating a colored test line (negative result). If Buprenorphine is at or above the cutoff, it binds to the antibody-dye conjugate, preventing the test line from forming (preliminary positive result). Designed for over-the-counter use by lay users in home or point-of-care settings. Results are visual and qualitative; they provide preliminary data only. Positive results require confirmation via GC/MS or LC/MS. The device assists in identifying Buprenorphine presence but does not distinguish between therapeutic use and abuse.
Clinical Evidence
No clinical studies were performed. Evidence consists of a lay-user study involving 140 participants per format (dip card and cup) across three sites. Participants with diverse backgrounds tested spiked urine samples at concentrations ranging from -75% to +75% of the cutoff. Results showed high agreement with GC/MS confirmation, with 100% agreement at most concentrations and 90% agreement at -25% of the cutoff.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Components include monoclonal antibody-dye conjugate with gold chloride, fixed drug-protein conjugates, and anti-mouse IgG polyclonal antibody on a membrane. Form factors: dip card and cup. No energy source required (capillary action).
Indications for Use
Indicated for the qualitative detection of Buprenorphine in human urine at a 10 ng/mL cutoff for over-the-counter use. Applicable to adults and individuals requiring preliminary screening for Buprenorphine presence. Does not differentiate between prescription use and drug abuse.
Regulatory Classification
Identification
An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An opiate 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).
