510(k) · Cleared
ClearedAcon Bup One Step Buprenorphine Test Strip
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 Feb 14, 2013 as substantially equivalent to K113624 (Guangzhou Wondfo Biotech Co., Ltd., 2012) after a 36-day review. Its family tree reaches back 2 generations to 2004.
- Decided
- Feb 14, 2013
- Review
- 36 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033047 (2004). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK033047 Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step…ACON Laboratories, Inc. · 2004
- 1 generation backK113624 Wondfo Buprenorphine Urine Test Wondfo Oxycodone Urine TestGuangzhou Wondfo Biotech Co., Ltd. · 2012
- This deviceK130055 Acon Bup One Step Buprenorphine Test StripGuangzhou Wondfo Biotech Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033047 | Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test… | ACON Laboratories, Inc. | 2004 | — |
| −1 | K113624 | Wondfo Buprenorphine Urine Test Wondfo Oxycodone Urine Test | Guangzhou Wondfo Biotech Co., Ltd. | 2012 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K113624 | Wondfo Buprenorphine Urine Test Wondfo Oxycodone Urine Test | 2012 |
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
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…
Read the full statement (157 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130055 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130055: Acon Bup One Step Buprenorphine Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130055
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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