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 Co. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on May 8, 2002 as substantially equivalent to K011673 (ACON Laboratories, Inc., 2001) and 5 other predicates after a 98-day review. Its family tree reaches back 2 generations to 1995. 88 later devices descend from it.
- Decided
- May 8, 2002
- Review
- 98 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K945610 (1995). 9 ancestors in all. 88 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 1 generation backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- This deviceK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 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 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · 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 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −1 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| 0 (this device) | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| +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 |
|---|---|---|
| 1996 | 2 | 0 |
| 2001 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 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 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? (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 |
|---|---|---|---|
| * | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test DeviceSummary page 2…ard and Test Device to compare their performance with clinical urine specimens. 510(k) Number for these predicate devices are: ACON AMP One Step Amphetamine Test Strip K011673 ACON mAMP One Step Methamphetamine Test Strip K011672 ACON COC One Step Cocaine Test Strip K010841 ACON OPI One Step Opiates Test… | 2001 |
| * | K011672 | Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test…Summary page 2…clinical urine specimens. 510(k) Number for these predicate devices are: ACON AMP One Step Amphetamine Test Strip K011673 ACON mAMP One Step Methamphetamine Test Strip K011672 ACON COC One Step Cocaine Test Strip K010841 ACON OPI One Step Opiates Test Strip K011353 ACON THC One Step Marijuana Test Strip… | 2001 |
| * | K010841 | Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test DeviceSummary page 2…these predicate devices are: ACON AMP One Step Amphetamine Test Strip K011673 ACON mAMP One Step Methamphetamine Test Strip K011672 ACON COC One Step Cocaine Test Strip K010841 ACON OPI One Step Opiates Test Strip K011353 ACON THC One Step Marijuana Test Strip K003557 ACON PCP One Step Phencyclidine Test… | 2001 |
| * | K011353 | Acon Opi One Step Opiates Test Strip, Acon Opi One Step Opiates Test DeviceSummary page 2…ep Amphetamine Test Strip K011673 ACON mAMP One Step Methamphetamine Test Strip K011672 ACON COC One Step Cocaine Test Strip K010841 ACON OPI One Step Opiates Test Strip K011353 ACON THC One Step Marijuana Test Strip K003557 ACON PCP One Step Phencyclidine Test Strip K011730 56 Comparison… | 2001 |
| * | K003557 | Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step Marijuana Test Device…Summary page 2…Step Methamphetamine Test Strip K011672 ACON COC One Step Cocaine Test Strip K010841 ACON OPI One Step Opiates Test Strip K011353 ACON THC One Step Marijuana Test Strip K003557 ACON PCP One Step Phencyclidine Test Strip K011730 56 Comparison to a Predicate Device: A comparison of the fea… | 2001 |
| * | K011730 | Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test DeviceSummary page 2…ne Step Cocaine Test Strip K010841 ACON OPI One Step Opiates Test Strip K011353 ACON THC One Step Marijuana Test Strip K003557 ACON PCP One Step Phencyclidine Test Strip K011730 56 Comparison to a Predicate Device: A comparison of the features of the ACON™ One Step Multi-Drug Multi-Line S… | 2001 |
What descends from it? (88)
See all 884 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug… | 2003 | 83 |
| K061005 | Accustep Doa Single and Multi-Strip Screen Panels | 2006 | 1 |
| K050936 | ON Call Home Drug Test for Marijuana and on Call Home Drug Test for Marijuana and Cocaine | 2005 | 0 |
| K050050 | ON Call Multi-Drug Home Test | 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K031759 (ACON Laboratories, Inc., 2003) has gone furthest, with 83 descendants of its own.
- 3 other devices also cite its predicate K011673.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
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 cut-off concentrations for these drugs are as follows: Amphetamine at 1,000 ng/ml, Cocaine at 300 ng/ml, Methamphetamine at 1,000 ng/ml, Opiates at 2,000 ng/ml, Marijuana at 50 ng/ml and Phencyclidine at 25 ng/ml. They are intended for healthcare professionals including professionals at the 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/K020313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020313: 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/K020313
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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