510(k) · Cleared
ClearedAcon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Jul 31, 2001 as substantially equivalent to K945610 (Princeton BioMeditech Corp., 1995) after a 62-day review. Its family tree reaches back 1 generation to 1995. 93 later devices descend from it.
- Decided
- Jul 31, 2001
- Review
- 62 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945610 (1995). 93 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- This deviceK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…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 · 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
- Descendant · 5 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
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 93 · See all- K020313Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug…Acon Laboratories Co. · 2002 · cites it directly88descendants
- 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
- K140748One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2014 · 5 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| 0 (this device) | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | 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 | — |
| +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 | — |
| +5 | K140748 | One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 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? (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 |
|---|---|---|---|
| * | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-AmpSummary page 2…ill always appear at the control line region if the test has been performed properly. Predicate Device: LifeSign Status DS™ AMP One-Step Amphetamine Test 510(k) Number K945610 Distributor: LifeSign 71 Veronica Avenue Somerset, New Jersey 08873 Comparison to a Predicate Device: A summary comparison of… | 1995 |
What descends from it? (93)
See all 934 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 |
| K041685 | Acon Multi-Clin Drug Screen Test Device | 2004 | 1 |
| K121065 | Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of… | 2013 | 0 |
| K041743 | Acon Tri-Fect Drug Screen Test Device | 2004 | 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?
- Its one ancestor has no recall.
- Of its descendants, K020313 (Acon Laboratories Co., 2002) has gone furthest, with 88 descendants of its own.
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 AMP One Step Amphetamine Test Strip and ACON AMP One Step Amphetamine Test Device are rapid chromatographic immunoassays for the qualitative detection of amphetamine in human urine at a cut-off concentration of 1,000 ng/mL. These tests are for professional and point of care use.
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/K011673 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011673: Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine 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/K011673
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026