510(k) · Cleared
ClearedWondfo Multi-Drug Urine Test Cup Model W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Wondfo Biotech Co., Ltd. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Nov 15, 2012 after a 55-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Nov 15, 2012
- Review
- 55 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK122904 Wondfo Multi-Drug Urine Test Cup Model W2002-CU; W2003-CU; W2004-CU…Guangzhou Wondfo Biotech Co., Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK150179 CR3 Keyless Split Sample Cup Oxycodone - CannabinoidsGuangzhou Wondfo Biotech Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK143535 CR3 Keyless Split Sample Cup Secobarbital- MethadoneGuangzhou Wondfo Biotech Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK151478 Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd. · 2015
Most influential descendants
Showing 3 of 3 · See all- K150179CR3 Keyless Split Sample Cup Oxycodone - CannabinoidsGuangzhou Wondfo Biotech Co., Ltd. · 2015 · cites it directly1descendant
- K143535CR3 Keyless Split Sample Cup Secobarbital- MethadoneGuangzhou Wondfo Biotech Co., Ltd. · 2015 · cites it directly1descendant
- K151478Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122904 | Wondfo Multi-Drug Urine Test Cup Model W2002-CU; W2003-CU; W2004-CU; W2005-CU… | Guangzhou Wondfo Biotech Co., Ltd. | 2012 | — |
| +1 | K150179 | CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
| +1 | K143535 | CR3 Keyless Split Sample Cup Secobarbital- Methadone | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
| +2 | 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 |
|---|---|---|
| 2015 | 3 | 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 DKZ? 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 DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 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?
The FDA summary names no predicate by number.
What descends from it? (3)
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?
- Of its descendants, K150179 (Guangzhou Wondfo Biotech Co., Ltd., 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, 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 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Wondfo Multi-Ding Urine Test Cup is competitive binding, lateral flow inmmochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Phencyclidine, Notriptyline and Oxycodone in human urine at the cutoff concentrations of: Drug(Identifier) Cut-off level Axnphetamine(AMP) 1000 ng/mL Secobarbital (BAR) 300 nglmL…
Read the full statement (370 words)
Wondfo Multi-Ding Urine Test Cup is competitive binding, lateral flow inmmochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Phencyclidine, Notriptyline and Oxycodone in human urine at the cutoff concentrations of:
Drug(Identifier) Cut-off level
Axnphetamine(AMP) 1000 ng/mL
Secobarbital (BAR) 300 nglmL
Oxazepam (BZO) 300 ng/mL
Cocaine (COC) 300 ng/mL
Cannabinoids (THC) 50 nglmL
Methamphetamine (MET) 1000 nglmL
Methylenedioxymethamphetamine (MDMA) 500 nglmL
Morphine (MOP) 300 ng/mL
Methadone (MTD) 300 nglmL
Phencyclidine (PCP) 25 nglmL
Notriptyline (ICA) 1000 nglmL
Oxycodane (OXY) 100 ng/mL
Configuration of the Wondfo Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GCIMS or LC/MS is the preferred confirmatory method.
The test will yield preliminary positive results when prescription drugs Notriptyline, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Wondfo Multi-Drug Urine Test Panel is competitive binding, lateral flow rimunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Phencyclidine, Notriptyline and Oxycodone in human urine at the cutoff concentrations of:
Drug(Identifier) Cut-off level
Amphetamine(AMP) 1000 nglmL
Secobarbital (BAR) 300 ng/mL
Oxazepamn (BZO) 300 nglmL
Cocaine (COC) 300 ng/mL
Cannabinoids (THC) 50 nglmL
Methamphetanine (MET) 1000 ng/mL
Methylenedioxymethaniphetamine (MDMA) 500 ng/mL
Morphine (MOP) 300 ng/mL
Methadone (MTD) 300 nglmL
Phencyclidine (PCP) 25 ng/mL
Notriptyline (TCA) 1000 nglmL
Oxycodone (OXY) 100 nglmL
Configuration of the 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 chemical method must be used in order to obtain a confirmed analytical result. GCIMS or LC/MS is the preferred confirmatory method.
The test will yield preliminary positive results when prescription drugs Notriptyline, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. 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/K122904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122904: Wondfo Multi-Drug Urine Test Cup Model W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122904
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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