510(k) · Cleared
ClearedOne Step Multiple Drugs of Abuse Assays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Wondfo Biotech Co., Ltd. · DIS Enzyme Immunoassay, Barbiturate
Cleared on Nov 17, 2005 as substantially equivalent to K020771 (ACON Laboratories, Inc., 2002) after a 316-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Nov 17, 2005
- Review
- 316 days
- Class
- Class II
- Product code
- DIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020771 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK020771 Acon One Step Drug Screen Test CardACON Laboratories, Inc. · 2002
- This deviceK050024 One Step Multiple Drugs of Abuse AssaysGuangzhou Wondfo Biotech Co., Ltd. · 2005
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) | K050024 | One Step Multiple Drugs of Abuse Assays | Guangzhou Wondfo Biotech Co., Ltd. | 2005 | — |
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 DIS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 2…fo Biotech Co. Ltd. The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: ACON Laboratories, Inc. One Step Drug Screen Test Card, K020771. Description of the device: Assay Principle: Immunochromatographic assay for drugs of abuse using a lateral flow, one… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 8 other devices also cite its predicate K020771.
How does its category compare?
All DIS devicesDIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIS
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIS
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIS
1in 2018
MAUDE reports naming product code DIS, 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 | 3 | 331 | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 29 | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
One Step Multiple Drugs of Abuse Assays is used for the qualitative determination of the following drugs of abuse in urine: Product Name — Cutoff Amphetamine (amphetamine) — 1000ng/ml Barbiturate (secobarbital) — 300ng/ml Benzodiazipines (oxazepam) — 300ng/ml Cocaine (benzoylecgonine) — 300ng/ml Methamphetamine (methamphetamine) — 10OOng/ml Morphine (morphine) — 300ng/ml Opiate (morphine) — 2000ng/ml Methadone (methadone) — 300ng/ml…
Read the full statement (184 words)
One Step Multiple Drugs of Abuse Assays is used for the qualitative determination of the following drugs of abuse in urine:
Product Name — Cutoff
Amphetamine (amphetamine) — 1000ng/ml
Barbiturate (secobarbital) — 300ng/ml
Benzodiazipines (oxazepam) — 300ng/ml
Cocaine (benzoylecgonine) — 300ng/ml
Methamphetamine (methamphetamine) — 10OOng/ml
Morphine (morphine) — 300ng/ml
Opiate (morphine) — 2000ng/ml
Methadone (methadone) — 300ng/ml
Methylenedioxymethamphetamine (methylenedioxymethamphetamine) — 500ng/ml
Phencyclidine (phencyclidine) — 25ng/ml
Tricyclic antidepressant drugs (nortriptyline) — 10OOng/ml
Cannabinoids (tetrahydrocannabinol-COOH) — 50ng/ml
The configurations of the One Step Multiple Drugs of Abuse Assays are available in any combination of the above tests. These devices are intended to be used by healthcare professionals only. For in vitro diagnostic use. Measurements obtained by this device are used in the diagnosis and treatment of use or overdose of the drugs listed above.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050024: One Step Multiple Drugs of Abuse Assays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050024
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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