510(k) · Cleared
ClearedAcon One Step Drug Screen Test Card
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on May 15, 2002 after a 68-day review. The FDA summary names no predicate by number. 21 later devices descend from it.
- Decided
- May 15, 2002
- Review
- 68 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 9 citing it directly.
- This deviceK020771 Acon One Step Drug Screen Test CardACON Laboratories, Inc. · 2002
- Descendant · cites it directly · 6 of its ownK112071 Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo…Guangzhou Wondfo Biotech Co., Ltd. · 2011
- Descendant · cites it directly · 6 of its ownK102203 Chemtrue Single / Multi Drug Screen Cassette / Dip Card TestsChemtron Biotech, Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK121339 Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette TestsChemtron Biotech, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK142580 Chemtrue Multi-Panel DOA DIP Card TestsChemtron Biotech, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK130665 Wondofo Multi-Drug Urine Test Cup / PanelGuangzhou Wondfo Biotech Co., Ltd. · 2013
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K112071Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo Methamphetamine Urine Test Model…Guangzhou Wondfo Biotech Co., Ltd. · 2011 · cites it directly6descendants
- K102203Chemtrue Single / Multi Drug Screen Cassette / Dip Card TestsChemtron Biotech, Inc. · 2011 · cites it directly6descendants
- K121339Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette TestsChemtron Biotech, Inc. · 2012 · 2 generations on5descendants
- K142580Chemtrue Multi-Panel DOA DIP Card TestsChemtron Biotech, Inc. · 2014 · 2 generations on4descendants
- K130665Wondofo Multi-Drug Urine Test Cup / PanelGuangzhou Wondfo Biotech Co., Ltd. · 2013 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +1 | K102203 | Chemtrue Single / Multi Drug Screen Cassette / Dip Card Tests | Chemtron Biotech, Inc. | 2011 | — |
| +2 | K121339 | Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests | Chemtron Biotech, Inc. | 2012 | — |
| +2 | K142580 | Chemtrue Multi-Panel DOA DIP Card Tests | Chemtron Biotech, Inc. | 2014 | — |
| +2 | K130665 | Wondofo Multi-Drug Urine Test Cup / Panel | Guangzhou Wondfo Biotech Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 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 3.0 · 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?
The FDA summary names no predicate by number.
What descends from it? (21)
See all 219 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112071 | Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo Methamphetamine Urine Test Model… | 2011 | 6 |
| K102203 | Chemtrue Single / Multi Drug Screen Cassette / Dip Card Tests | 2011 | 6 |
| K121557 | Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine Test | 2012 | 1 |
| K121987 | Wondfo Amphetamine Urine Test Wondfo Barbiturates Urine Test Wondfo Benzodiazepines… | 2012 | 0 |
| K112236 | Wondfo Methylenedioxymethamphetamine Urine Test, Wondfo Morphine Urine Test | 2011 | 0 |
| K112395 | Wondfo Phencyclidine Urine Test, Tricyclic Antidepressants Urine Test | 2011 | 0 |
| K111560 | Wondfo Amphetamine Urine Test, Wondfo Barbiturates Urine Test, Wondfo Benzodiazepines… | 2011 | 0 |
| K110182 | Cannabinoids Urine Test | 2011 | 0 |
| K050024 | One Step Multiple Drugs of Abuse Assays | 2005 | 0 |
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, K112071 (Guangzhou Wondfo Biotech Co., Ltd., 2011) has gone furthest, with 6 descendants of its own.
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.
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?
The ACON One Step Drug Screen Test Card and ACON One Step Drug Screen Test Card with Integrated Cup are rapid chromatographic immunoassay devices for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, and/or barbiturate in human urine. The test is calibrated against analytes with their respective cutoff concentrations listed in the following table. Test —…
Read the full statement (185 words)
The ACON One Step Drug Screen Test Card and ACON One Step Drug Screen Test Card with Integrated Cup are rapid chromatographic immunoassay devices for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, and/or barbiturate in human urine. The test is calibrated against analytes with their respective cutoff concentrations listed in the following table.
Test — Calibrator — Cut-off
Amphetamine (AMP) — D-Amphetamine — 1,000 ng/mL
Barbiturates (BAR) — Secobarbital — 300 ng/mL
Benzodiazepines (BZO) — Oxazepam — 300 ng/mL
Cocaine (COC) — Benzoylecgonine — 300 ng/mL
Methamphetamine (mAMP) — D-Methamphetamine — 1,000 ng/mL
Morphine (MOP 300 or OPI 300) — Morphine — 300 ng/mL
Methadone (MTD) — Methadone — 300 ng/mL
Opiates (OPI 2000) — Morphine — 2,000 ng/mL
Phencyclidine (PCP) — Phencyclidine — 25 ng/mL
Marijuana (THC) — 11-nor-A’-THC-9 COOH — 50 ng/mL
The configurations of the ACON One Step Multi-Drug Screen Test Card and ACON One Step Multi-Drug Screen Test Card with Integrated Cup come with any combination of the above listed drug analytes. They are intended for the healthcare professionals including professionals at point-of-care sites.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020771: Acon One Step Drug Screen Test Card.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020771
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