# K093175: Wondfo One Step Buprenorphine Urine Test, Oxycodone Urine Test, Propoxphene Urine Test, Multiple Drug of Abuse Urine Tes

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Aug 25, 2010 after 321 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). 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)
- 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.
- K040445: Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test Device, ACON Laboratories, Inc. (2004) Summary page 1.

## Indications for use
The Wondfo One Step Buprenorphine Urine Test Strip is intended for the qualitative determination of buprenorphine in human urine at the cut-off concentration of 10 ng/ml. The assay is in strip format. The device is intended for healthcare professionals in a central laboratory setting only and is not for use in point-of-care settings. For in vitro diagnostic use. This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods. The Wondfo One Step Oxycodone Urine Test Strip is intended for the qualitative determination of oxycodone in human urine at the cut-off concentration of 100 ng/ml. The assay is in strip format. The device is intended for healthcare professionals in a central laboratory setting only and is not for use in point-of-care settings. For in vitro diagnostic use. This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods. The Wondfo One Step Propoxyphene Urine Test Strip is intended for the qualitative determination of propoxyphene in human urine at the cut-off concentration of 300 ng/ml. The assay is in strip format. The device is intended for healthcare professionals in a central laboratory setting only and is not for use in point-of-care settings. For in vitro diagnostic use. This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods.

Source page: https://510kreport.com/device/K093175
Methodology: https://510kreport.com/methodology