# K113624: Wondfo Buprenorphine Urine Test Wondfo Oxycodone Urine Test

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Mar 12, 2012 after 95 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: 1 generation back to K033047 (2004). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060466: Acon Bup One Step Buprenorphine Test Strip and Acron Bup One Step Buprenorphine Test Device, ACON Laboratories, Inc. (2006) Summary page 1.
- K033047: Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test Device, ACON Laboratories, Inc. (2004) Summary page 1.

## Most influential descendants
- K130055: Acon Bup One Step Buprenorphine Test Strip (2013), 0 descendants of its own

## 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 ngimL. The test is available in a dip card format and a cup format. For in vitro diagnostic use only. 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 conformed analytical result. GCIMS 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. Wondfo Oxycodone Urine Test is an immunochromatographic assay for the qualitative determination of Oxycodone in human urine at a cutoff concentration of 100 nglmL. The test is available in a dip card format and a cup format. For in vitro diagnostic use only. This product is intended for over-the-counter and prescription use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GCIMS or LC/NIS 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.

Source page: https://510kreport.com/device/K113624
Methodology: https://510kreport.com/methodology