510(k) · Cleared
ClearedAcon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug Multi-Line Screen Test Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · DIS Enzyme Immunoassay, Barbiturate
Cleared on Feb 5, 2003 as substantially equivalent to K012824 (ACON Laboratories, Inc., 2001) and 4 other predicates after a 70-day review. Its family tree reaches back 2 generations to 1999. 86 later devices descend from it.
- Decided
- Feb 5, 2003
- Review
- 70 days
- Class
- Class II
- Product code
- DIS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K991079 (1999). 8 ancestors in all, the oldest K980249 (1998). 86 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK991079 Accusign Bzo, Biosign Bzo, Status BzoPrinceton BioMeditech Corp. · 1999
- 1 generation backK012300 Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step…ACON Laboratories, Inc. · 2001
- This deviceK023946 Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step…ACON Laboratories, Inc. · 2003
- Descendant · cites it directly · 83 of its ownK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 80 of its ownK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 55 of its ownK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- Descendant · 4 generations on · 16 of its ownK140748 One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test…Co-Innovation Biotech Co., Ltd. · 2014
- Descendant · 4 generations on · 13 of its ownK182701 Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd. · 2018 · Recalled
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 86 · See all- K031759Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug…ACON Laboratories, Inc. · 2003 · cites it directly83descendants
- K061718Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · 2 generations on80descendants
- K122809Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013 · 3 generations on55descendants
- K140748One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2014 · 4 generations on16descendants
- K182701Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd. · 2018 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991079 | Accusign Bzo, Biosign Bzo, Status Bzo | Princeton BioMeditech Corp. | 1999 | — |
| −1 | K012300 | Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step… | ACON Laboratories, Inc. | 2001 | — |
| 0 (this device) | K023946 | Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug… | ACON Laboratories, Inc. | 2003 | — |
| +1 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| +2 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| +3 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| +4 | K140748 | One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2014 | — |
| +4 | K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 9 | 0 |
| 2016 | 9 | 0 |
| 2017 | 2 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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 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? (6)
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 |
|---|---|---|---|
| * | K012824 | Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step Barbiturates Test Device | 2001 |
| * | K012300 | Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step Benzodiazepines Test… | 2001 |
| * | K022589 | Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test Device | 2002 |
| * | K011353 | Acon Opi One Step Opiates Test Strip, Acon Opi One Step Opiates Test Device | 2001 |
| * | K021526 | Acon Tca One Step Tricyclic Antidepressant Test Strip and Device | 2002 |
| * | — | ACON MTD One Step Methadone Test Strip Named without a submission number |
What descends from it? (86)
See all 862 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 4 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K031759 (ACON Laboratories, Inc., 2003) has gone furthest, with 83 descendants of its own.
- 2 other devices also cite its predicate K012824.
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?
The ACON@One Step Multi-Drug Multi-Line Screen Test Card and Test Device are rapid chromatographic immunoassays for the qualitative and simultaneous detection of two to six drugs in a variety of combinations in human urine. The designated Cutoff concentrations for these drugs are as follows: Analyte — Abbreviation — Calibrator — Cutoff Conc. Barbiturates — BAR — Secobarbital — 300 ng/mL Benzodiazepines — BZO — Oxazepam — 300 ng/mL Methadone — MTD —…
Read the full statement (119 words)
The ACON@One Step Multi-Drug Multi-Line Screen Test Card and Test Device are rapid chromatographic immunoassays for the qualitative and simultaneous detection of two to six drugs in a variety of combinations in human urine. The designated Cutoff concentrations for these drugs are as follows:
Analyte — Abbreviation — Calibrator — Cutoff Conc.
Barbiturates — BAR — Secobarbital — 300 ng/mL
Benzodiazepines — BZO — Oxazepam — 300 ng/mL
Methadone — MTD — Methadone — 300 ng/mL
MDMA (Ecstasy) — MDMA — MDMA — 500 ng/mL
Opiates — MOP or OP1 — Morphine — 300 ng/mL
Tricyclic Antidepressants — TCA — Nortriptyline — 1,000 ng/mL
These tests are intended for healthcare professionals including professionals at the point of care sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023946: Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug Multi-Line Screen Test Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023946
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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