510(k) · Cleared
Recalled · Class II · 2022Wondfo Multi-Drug Urine Test Cup, Panel
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 Feb 25, 2014 as substantially equivalent to K112071 (Guangzhou Wondfo Biotech Co., Ltd., 2011) after a 61-day review. Its family tree reaches back 2 generations to 2002. It has been recalled once.
- Decided
- Feb 25, 2014
- Review
- 61 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020771 (2002). 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 backK112071 Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo…Guangzhou Wondfo Biotech Co., Ltd. · 2011
- This deviceK133968 Wondfo Multi-Drug Urine Test Cup, PanelGuangzhou Wondfo Biotech Co., Ltd. · 2014
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 | K112071 | Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo Methamphetamine Urine… | Guangzhou Wondfo Biotech Co., Ltd. | 2011 | — |
| 0 (this device) | K133968 | Wondfo Multi-Drug Urine Test Cup, Panel | Guangzhou Wondfo Biotech Co., Ltd. | 2014 | — |
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? (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 |
|---|---|---|---|
| * | K112071 | Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo Methamphetamine Urine Test Model…Summary page 3…New Devices, Predicate devices (K112071) Indication(s) for For the qualitative determination of Amphetamine For the qualitative determination of use… | 2011 |
| † | K121987 | Wondfo Amphetamine Urine Test Wondfo Barbiturates Urine Test Wondfo Benzodiazepines… | 2012 |
| † | K112557 | Stryker Universal Neuro 3 System | 2012 |
| † | K112236 | Wondfo Methylenedioxymethamphetamine Urine Test, Wondfo Morphine Urine Test | 2011 |
| † | K112310 | Wondfo Methadone Urine Test,Opiate Test | 2011 |
| † | K112395 | Wondfo Phencyclidine Urine Test, Tricyclic Antidepressants Urine Test | 2011 |
| † | K113624 | Wondfo Buprenorphine Urine Test Wondfo Oxycodone Urine Test | 2012 |
| † | K130055 | Acon Bup One Step Buprenorphine Test Strip | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class II | Z-1589-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K112071.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of: Amphetamine (AMP): 1000 ng/mL…
Read the full statement (444 words)
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of:
Amphetamine (AMP): 1000 ng/mL
Secobarbital (BAR): 300 ng/mL
Oxazepam (BZO): 300 ng/mL
Cocaine (COC): 300 ng/mL
Cannabinoids (THC): 50 ng/mL
Methamphetamine (MET): 1000 ng/mL
Methylenedioxymethamphetamine (MDMA): 500 ng/mL
Morphine (MOP): 300 ng/mL
Phencyclidine (PCP): 25 ng/mL
Oxycodone (OXY): 100 ng/mL
Buprenorphine (BUP): 10 ng/mL
Methadone (MTD): 300 ng/mL
Notriptyline (TCA): 1000 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. GC/MS or LC/MS is the preferred confirmatory method.
The test may yield positive results for the prescription drugs buprenorphine, oxazepam, oxycodone, and secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs.
Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of:
Amphetamine (AMP): 1000 ng/mL
Secobarbital (BAR): 300 ng/mL
Oxazepam (BZO): 300 ng/mL
Cocaine (COC): 300 ng/mL
Cannabinoids (THC): 50 ng/mL
Methamphetamine (MET): 1000 ng/mL
Methylenedioxymethamphetamine (MDMA): 500 ng/mL
Morphine (MOP): 2000 ng/mL
Phencyclidine (PCP): 25 ng/mL
Oxycodone (OXY): 100 ng/mL
Buprenorphine (BUP): 10 ng/mL
Methadone (MTD): 300 ng/mL
Notriptyline (TCA): 1000 ng/mL
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. GC/MS or LC/MS is the preferred confirmatory method.
The test may yield positive results for the prescription drugs buprenorphine, oxazepam, oxycodone, and secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs.
Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133968 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133968: Wondfo Multi-Drug Urine Test Cup, Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133968
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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