510(k) · Cleared
ClearedWondfo One Step Buprenorphine Urine Test, Oxycodone Urine Test, Propoxphene Urine Test, Multiple Drug of Abuse Urine Tes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Wondfo Biotech Co., Ltd. · DJG Enzyme Immunoassay, Opiates
Cleared on Aug 25, 2010 as substantially equivalent to K060466 (ACON Laboratories, Inc., 2006) and 2 other predicates after a 321-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Aug 25, 2010
- Review
- 321 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K033047 (2004). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK033047 Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step…ACON Laboratories, Inc. · 2004
- This deviceK093175 Wondfo One Step Buprenorphine Urine Test, Oxycodone Urine Test…Guangzhou Wondfo Biotech Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033047 | Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test… | ACON Laboratories, Inc. | 2004 | — |
| 0 (this device) | K093175 | Wondfo One Step Buprenorphine Urine Test, Oxycodone Urine Test, Propoxphene… | Guangzhou Wondfo Biotech Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DJG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060466 | Acon Bup One Step Buprenorphine Test Strip and Acron Bup One Step Buprenorphine Test…Summary page 1…3700 4. The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: 1. Acon Laboratories, Inc. Acon BUP One Step Buprenorphene Test Strip, K060466. 2. Aeon Laboratories, Inc. Acon OXY One Step Oxycodone Test Strip, K033047 3. Aeon Laboratories, Inc. Acon PPX O… | 2006 |
| * | K033047 | Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test DeviceSummary page 1…)(3)]: 1. Acon Laboratories, Inc. Acon BUP One Step Buprenorphene Test Strip, K060466. 2. Aeon Laboratories, Inc. Acon OXY One Step Oxycodone Test Strip, K033047 3. Aeon Laboratories, Inc. Acon PPX One Step Propoxyplhene Test Strip, K(040445… | 2004 |
| * | K040445 | Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test DeviceSummary page 1…0466. 2. Aeon Laboratories, Inc. Acon OXY One Step Oxycodone Test Strip, K033047 3. Aeon Laboratories, Inc. Acon PPX One Step Propoxyplhene Test Strip, K(040445 Premnarket Notification - Guangzhou Wondfo Biotech Co. Ltd. 5.… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K060466.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
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…
Read the full statement (345 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093175: Wondfo One Step Buprenorphine Urine Test, Oxycodone Urine Test, Propoxphene Urine Test, Multiple Drug of Abuse Urine Tes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093175
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026