510(k) · Cleared
ClearedWondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo Methamphetamine Urine Test Model W11-CU, W11-P
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 Sep 23, 2011 as substantially equivalent to K020771 (ACON Laboratories, Inc., 2002) after a 65-day review. Its family tree reaches back 1 generation to 2002. 6 later devices descend from it.
- Decided
- Sep 23, 2011
- Review
- 65 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020771 (2002). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK020771 Acon One Step Drug Screen Test CardACON Laboratories, Inc. · 2002
- This deviceK112071 Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo…Guangzhou Wondfo Biotech Co., Ltd. · 2011
- Descendant · cites it directly · 4 of its ownK130665 Wondofo Multi-Drug Urine Test Cup / PanelGuangzhou Wondfo Biotech Co., Ltd. · 2013
- Descendant · 2 generations on · 1 of its ownK142044 CR3 Keyless Split Sample Cup Phencyclidien -…Guangzhou Wondfo Biotech Co., Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK141532 CR3 Keyless Split Sample Cup Amphetamine-CocaineGuangzhou Wondfo Biotech Co., Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK140089 CR3 Keyless Split Sample Cup (Opi-Bzo)Guangzhou Wondfo Biotech Co., Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK151478 Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K130665Wondofo Multi-Drug Urine Test Cup / PanelGuangzhou Wondfo Biotech Co., Ltd. · 2013 · cites it directly4descendants
- K142044CR3 Keyless Split Sample Cup Phencyclidien - MethylenedioxymethamphetamineGuangzhou Wondfo Biotech Co., Ltd. · 2014 · 2 generations on1descendant
- K141532CR3 Keyless Split Sample Cup Amphetamine-CocaineGuangzhou Wondfo Biotech Co., Ltd. · 2014 · 2 generations on1descendant
- K140089CR3 Keyless Split Sample Cup (Opi-Bzo)Guangzhou Wondfo Biotech Co., Ltd. · 2014 · 2 generations on1descendant
- K151478Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd. · 2015 · 3 generations on0descendants
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) | K112071 | Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo Methamphetamine Urine… | Guangzhou Wondfo Biotech Co., Ltd. | 2011 | — |
| +1 | K130665 | Wondofo Multi-Drug Urine Test Cup / Panel | Guangzhou Wondfo Biotech Co., Ltd. | 2013 | — |
| +2 | K142044 | CR3 Keyless Split Sample Cup Phencyclidien - Methylenedioxymethamphetamine | Guangzhou Wondfo Biotech Co., Ltd. | 2014 | — |
| +2 | K141532 | CR3 Keyless Split Sample Cup Amphetamine-Cocaine | Guangzhou Wondfo Biotech Co., Ltd. | 2014 | — |
| +2 | K140089 | CR3 Keyless Split Sample Cup (Opi-Bzo) | Guangzhou Wondfo Biotech Co., Ltd. | 2014 | — |
| +3 | K151478 | Wondfo CR3 Keyless Split Sample Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 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 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 3.1 · 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 |
|---|---|---|---|
| * | K020771 | Acon One Step Drug Screen Test CardSummary page 1…LAF 21CFR 862.3610 4. The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Acon Laboratories, Inc. One Step Drug Screen Test, K020771. 5. Description of the device: Assay Principle: lmmunochromatograph assay for Cocaine and Methamphetamine Urine… | 2002 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Cocaine Urine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a cutoff concentration of 300ng~mL. 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. GC/MS is the…
Read the full statement (199 words)
Wondfo Cocaine Urine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a cutoff concentration of 300ng~mL. 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. GC/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 Methamphetamine Urine Test is an immunochromatographic assay for the qualitative determination of D(+)-Methamphetamine in human urine at a cutoff concentration of 1000 ng/mL. 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. GC/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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112071 · printed Nov 5, 2026
Cite this page
510(k) Report. “K112071: Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo Methamphetamine Urine Test Model W11-CU, W11-P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K112071
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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