510(k) · Cleared
ClearedWondofo 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. · DJG Enzyme Immunoassay, Opiates
Cleared on Apr 9, 2013 as substantially equivalent to K112071 (Guangzhou Wondfo Biotech Co., Ltd., 2011) after a 28-day review. Its family tree reaches back 2 generations to 2002. 4 later devices descend from it.
- Decided
- Apr 9, 2013
- Review
- 28 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020771 (2002). 4 later devices descend from it, 3 citing it directly.
- 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 deviceK130665 Wondofo Multi-Drug Urine Test Cup / PanelGuangzhou Wondfo Biotech Co., Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK142044 CR3 Keyless Split Sample Cup Phencyclidien -…Guangzhou Wondfo Biotech Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK141532 CR3 Keyless Split Sample Cup Amphetamine-CocaineGuangzhou Wondfo Biotech Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK140089 CR3 Keyless Split Sample Cup (Opi-Bzo)Guangzhou Wondfo Biotech Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK151478 Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd. · 2015
Most influential descendants
Showing 4 of 4 · See all- K142044CR3 Keyless Split Sample Cup Phencyclidien - MethylenedioxymethamphetamineGuangzhou Wondfo Biotech Co., Ltd. · 2014 · cites it directly1descendant
- K141532CR3 Keyless Split Sample Cup Amphetamine-CocaineGuangzhou Wondfo Biotech Co., Ltd. · 2014 · cites it directly1descendant
- K140089CR3 Keyless Split Sample Cup (Opi-Bzo)Guangzhou Wondfo Biotech Co., Ltd. · 2014 · 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 |
|---|---|---|---|---|---|
| −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) | K130665 | Wondofo Multi-Drug Urine Test Cup / Panel | Guangzhou Wondfo Biotech Co., Ltd. | 2013 | — |
| +1 | K142044 | CR3 Keyless Split Sample Cup Phencyclidien - Methylenedioxymethamphetamine | Guangzhou Wondfo Biotech Co., Ltd. | 2014 | — |
| +1 | K141532 | CR3 Keyless Split Sample Cup Amphetamine-Cocaine | Guangzhou Wondfo Biotech Co., Ltd. | 2014 | — |
| +1 | K140089 | CR3 Keyless Split Sample Cup (Opi-Bzo) | Guangzhou Wondfo Biotech Co., Ltd. | 2014 | — |
| +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 |
|---|---|---|
| 2014 | 3 | 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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 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… | 2011 |
What descends from it? (4)
3 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?
- The line of descent spans 11 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.
- Of its descendants, K142044 (Guangzhou Wondfo Biotech Co., Ltd., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K112071.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
Wondfo Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine in human urine at the cutoff concentrations of: Drug (Identifier) — Cut-off level Amphetamine (AMP) — 1000 ng/mL Secobarbital (BAR) — 300…
Read the full statement (404 words)
Wondfo Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine in human urine at the cutoff concentrations of:
Drug (Identifier) — Cut-off level
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
Morphine 2000 (OPI) — 2000 ng/mL
Phencyclidine (PCP) — 25 ng/mL
Oxycodone (OXY) — 100 ng/mL
Buprenorphine (BUP) — 10 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 will yield preliminary positive results when prescription drugs Buprenorphine, 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 immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine in human urine at the cutoff concentrations of:
Drug (Identifier) — Cut-off level
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
Morphine 2000 (OPI) — 2000 ng/mL
Phencyclidine (PCP) — 25 ng/mL
Oxycodone (OXY) — 100 ng/mL
Buprenorphine (BUP) — 10 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 will yield preliminary positive results when prescription drugs Buprenorphine, 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/K130665 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130665: Wondofo 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/K130665
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