510(k) · Cleared
ClearedWondfo Propoxyphene Urine Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Wondfo Biotech Co., Ltd. · JXN Enzyme Immunoassay, Propoxyphene
Cleared on Nov 23, 2015 as substantially equivalent to K121557 (Guangzhou Wondfo Biotech Co., Ltd., 2012) after an 83-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Nov 23, 2015
- Review
- 83 days
- Class
- Class II
- Product code
- JXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020771 (2002). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK020771 Acon One Step Drug Screen Test CardACON Laboratories, Inc. · 2002
- 1 generation backK121557 Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine TestGuangzhou Wondfo Biotech Co., Ltd. · 2012
- This deviceK152495 Wondfo Propoxyphene Urine TestGuangzhou Wondfo Biotech Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020771 | Acon One Step Drug Screen Test Card | ACON Laboratories, Inc. | 2002 | — |
| −1 | K121557 | Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine Test | Guangzhou Wondfo Biotech Co., Ltd. | 2012 | — |
| 0 (this device) | K152495 | Wondfo Propoxyphene Urine Test | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 JXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K121557 | Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine TestSummary page 4…CFR # Panel JXN 21 CFR, 862.3700 Propoxyphene Test System Toxicology 5. Predicate Devices: K121557 Wondfo Propoxyphene Urine Test 6. Intended Use: Wondfo Propoxyphene Urine Test is an immunochromat… | 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 13 years and passes through 2 companies; a new generation was cleared every 10.2 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All JXN devicesJXN Enzyme Immunoassay, Propoxyphene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JXN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · JXN
Too few JXN 510(k)s in any year since 2007 to give a median.
Recalls per year · JXN
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXN
1in 2024
MAUDE reports naming product code JXN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Wondfo Propoxyphene Urine Test is an immunochromatographic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentration of 300 ng/mL. The test is available in a dip card format and a test cup format. It is intended for prescription use and over the counter use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result.…
Read the full statement (143 words)
Wondfo Propoxyphene Urine Test is an immunochromatographic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentration of 300 ng/mL. The test is available in a dip card format and a test cup format. It is intended for prescription use and over the counter use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. The test will yield preliminary positive results when prescription drug d-Propoxyphene is ingested, even at or above therapeutic doses. There is no uniformly recognized cutoff concentration for d-Propoxyphene. It is not intended to distinguish between prescription use or abuse of this drug. 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/K152495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152495: Wondfo Propoxyphene 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/K152495
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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