510(k) · Cleared
ClearedWondfo Buprenorphine Urine Test Wondfo Oxycodone Urine Test
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 Mar 12, 2012 as substantially equivalent to K060466 (ACON Laboratories, Inc., 2006) and 1 other predicate after a 95-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.
- Decided
- Mar 12, 2012
- Review
- 95 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K033047 (2004). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK033047 Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step…ACON Laboratories, Inc. · 2004
- This deviceK113624 Wondfo Buprenorphine Urine Test Wondfo Oxycodone Urine TestGuangzhou Wondfo Biotech Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK130055 Acon Bup One Step Buprenorphine Test StripGuangzhou Wondfo Biotech Co., Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K130055Acon Bup One Step Buprenorphine Test StripGuangzhou Wondfo Biotech Co., Ltd. · 2013 · cites it directly0descendants
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) | K113624 | Wondfo Buprenorphine Urine Test Wondfo Oxycodone Urine Test | Guangzhou Wondfo Biotech Co., Ltd. | 2012 | — |
| +1 | K130055 | Acon Bup One Step Buprenorphine Test Strip | Guangzhou Wondfo Biotech Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (2)
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…ing equivalence [807.92(a)(3)]: 1. Acon Laboratories, Inc. Acon BUIP One Step Buprenorphene Test Strip and Acon BUP One Step Buprenorphene Test Device, K060466. 2. Acon Laboratories, Inc. Acon OXY One Step Oxycodone Test Strip and Acon OXY One Step Oxycodone Test Device,… | 2006 |
| * | K033047 | Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test DeviceSummary page 1…Step Buprenorphene Test Device, K060466. 2. Acon Laboratories, Inc. Acon OXY One Step Oxycodone Test Strip and Acon OXY One Step Oxycodone Test Device, K033047 5. Description of the device: Assay Principle: Immunochromatograph assay for Buprenorphine and Oxycodone Urine Test… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130055 | Acon Bup One Step Buprenorphine Test Strip | 2013 | 0 |
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?
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
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…
Read the full statement (218 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113624: Wondfo Buprenorphine Urine Test Wondfo Oxycodone Urine Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113624
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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