# K130055: Acon Bup One Step Buprenorphine Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Feb 14, 2013 after 36 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K033047 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113624: Wondfo Buprenorphine Urine Test Wondfo Oxycodone Urine Test, Guangzhou Wondfo Biotech Co., Ltd. (2012)

## Indications for use
Wondfob Buprenorphine Urine Test is an immunochromatographic assay for the qualitative determination of B~uprenorphine 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 B~uprenorphine 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.

Source page: https://510kreport.com/device/K130055
Methodology: https://510kreport.com/methodology