510(k) · Cleared
ClearedWondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Wondfo Biotech Co., Ltd. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on May 8, 2012 after a 21-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- May 8, 2012
- Review
- 21 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK121166 Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test PanelGuangzhou Wondfo Biotech Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK130275 Quikscreen Multi (Mdma and Opi) Otc Drug Cup TestTianjin New Bay Bioresearch Co., Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K130275Quikscreen Multi (Mdma and Opi) Otc Drug Cup TestTianjin New Bay Bioresearch Co., Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K121166 | Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel | Guangzhou Wondfo Biotech Co., Ltd. | 2012 | — |
| +1 | K130275 | Quikscreen Multi (Mdma and Opi) Otc Drug Cup Test | Tianjin New Bay Bioresearch Co., Ltd. | 2013 | — |
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 DIO? 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 DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 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 |
|---|---|---|---|
| * | — | Wondfo single DOA Tests Named without a submission number |
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 |
|---|---|---|---|
| K130275 | Quikscreen Multi (Mdma and Opi) Otc Drug Cup Test | 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?
- Of its descendants, K130275 (Tianjin New Bay Bioresearch Co., Ltd., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, 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 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow lmmunochromatographic assays for qualitative and simultaneous detection of Cocaine, Methadone, Methamphetamine, Methylenedioxymethamphetamnine, Morphine, Morphine 2000, Phencyclidine, Notriptyline in human urine at the cutoff concentrations of: Configuration of the Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel can…
Read the full statement (120 words)
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding,
lateral flow lmmunochromatographic assays for qualitative and simultaneous detection of Cocaine,
Methadone, Methamphetamine, Methylenedioxymethamphetamnine, Morphine, Morphine 2000,
Phencyclidine, Notriptyline in human urine at the cutoff concentrations of:
Configuration of the Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel can
consist of any combination of the above listed drug analytes.
The test provides only preliminary test results. A more specific alternative chenilcal method must be
used in order to obtain a confirmed analytical result GC/MS or LCIMS 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/K121166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121166: Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121166
Report an extraction error
Are you the manufacturer?
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