510(k) · Cleared
ClearedWondfo Cannabinoids Urine Test Wondfo 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. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Jul 25, 2012 as substantially equivalent to K020771 (ACON Laboratories, Inc., 2002) and 1 other predicate after a 61-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.
- Decided
- Jul 25, 2012
- Review
- 61 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K020771 (2002). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK020771 Acon One Step Drug Screen Test CardACON Laboratories, Inc. · 2002
- This deviceK121557 Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine TestGuangzhou Wondfo Biotech Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK152495 Wondfo Propoxyphene Urine TestGuangzhou Wondfo Biotech Co., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K152495Wondfo Propoxyphene Urine TestGuangzhou Wondfo Biotech Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020771 | Acon One Step Drug Screen Test Card | ACON Laboratories, Inc. | 2002 | — |
| 0 (this device) | K121557 | Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine Test | Guangzhou Wondfo Biotech Co., Ltd. | 2012 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 LDJ? 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 LDJ device
- #1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 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 |
|---|---|---|---|
| * | K020771 | Acon One Step Drug Screen Test CardSummary page 1…21 CFR 862.3700 4. The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: 1. Acon Laboratories, Inc. ACON One Step Drug Screen Test, K020771. 2. Acon Laboratories, Inc. ACON One Step Propoxyphene Test Device and Test Strip, K040445 5. Description of the device… | 2002 |
| * | K040445 | Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test DeviceSummary page 1…)]: 1. Acon Laboratories, Inc. ACON One Step Drug Screen Test, K020771. 2. Acon Laboratories, Inc. ACON One Step Propoxyphene Test Device and Test Strip, K040445 5. Description of the device: Assay Principle: lmmunochromatograph assay for Cannabinoids and Propoxyphene 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 |
|---|---|---|---|
| K152495 | Wondfo Propoxyphene Urine Test | 2015 | 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 LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LDJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDJ
48in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDJ
1in 2015
MAUDE reports naming product code LDJ, 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 | 2 | — | 4 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 219 | 0 | 0 |
| 2012 | 4 | 193 | 0 | 0 |
| 2013 | 3 | 162 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 48 | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Wondfo Propoxyphene Urine Test is an immunochromatogmaphic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentmation of 300 nglmL. The test is available in a dip card format and a cup format. This product is only intended for 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 is the…
Read the full statement (201 words)
Wondfo Propoxyphene Urine Test is an immunochromatogmaphic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentmation of 300 nglmL. The test is available in a dip card format and a cup format. This product is only intended for 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 is the preferred confirmatory method. Clinical considemation and professional judgment should .be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Wondfo Cannabinoids Urine Test is an immunochromatographic assay for the qualitative determination of 11-nor-AS-THC-9-COOH (major metabolite of Cannabinoids) in human urine at a cutoff concentration of 50 nglrnL. The test is available in a dip card format and a 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 conformed analytical result. GCIMS 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/K121557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121557: Wondfo Cannabinoids Urine Test 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/K121557
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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