510(k) · Cleared
ClearedAcon Opi One Step Opiates Test Strip, Acon Opi One Step Opiates Test Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Jul 30, 2001 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 91 later devices descend from it.
- Decided
- Jul 30, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 0
91 later devices descend from it, 3 citing it directly.
- This deviceK011353 Acon Opi One Step Opiates Test Strip, Acon Opi One Step Opiates Test…ACON Laboratories, Inc. · 2001
- Descendant · cites it directly · 88 of its ownK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- Descendant · cites it directly · 86 of its ownK023946 Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step…ACON Laboratories, Inc. · 2003
- Descendant · 2 generations on · 83 of its ownK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 80 of its ownK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 55 of its ownK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K020313Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug…Acon Laboratories Co. · 2002 · cites it directly88descendants
- K023946Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug…ACON Laboratories, Inc. · 2003 · cites it directly86descendants
- K031759Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug…ACON Laboratories, Inc. · 2003 · 2 generations on83descendants
- K061718Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · 3 generations on80descendants
- K122809Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013 · 4 generations on55descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011353 | Acon Opi One Step Opiates Test Strip, Acon Opi One Step Opiates Test Device | ACON Laboratories, Inc. | 2001 | — |
| +1 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| +1 | K023946 | Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug… | ACON Laboratories, Inc. | 2003 | — |
| +2 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| +3 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| +4 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (91)
See all 913 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | 2002 | 88 |
| K023946 | Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug… | 2003 | 86 |
| K121065 | Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of… | 2013 | 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, K020313 (Acon Laboratories Co., 2002) has gone furthest, with 88 descendants of its own.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K011353 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011353: Acon Opi One Step Opiates Test Strip, Acon Opi One Step Opiates Test Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011353
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026