510(k) · Cleared
ClearedAccustep Doa Single and Multi-Strip Screen Panels
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Dna Technologies, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Oct 4, 2006 as substantially equivalent to K023946 (ACON Laboratories, Inc., 2003) and 1 other predicate after a 176-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Oct 4, 2006
- Review
- 176 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K945610 (1995). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 2 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 1 generation backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- This deviceK061005 Accustep Doa Single and Multi-Strip Screen PanelsApplied Dna Technologies, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK082977 Bionexia Opticup Multi-Strip Doa Dipstick Test Integrated CupMk Bio, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K082977Bionexia Opticup Multi-Strip Doa Dipstick Test Integrated CupMk Bio, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −2 | 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 | — |
| 0 (this device) | K061005 | Accustep Doa Single and Multi-Strip Screen Panels | Applied Dna Technologies, Inc. | 2006 | — |
| +1 | K082977 | Bionexia Opticup Multi-Strip Doa Dipstick Test Integrated Cup | Mk Bio, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K023946 | Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug…Summary page 2…/MS confirmed clinical urine specimens. 510(k) number for these predicate devices are: ACON One Step Multi-Drug and Multi-Line Screen Test Card and Device K023946 ACON One Step Multi-Drug and Multi-Line Screen Test Card and Device K020313 Performance: The product performance c… | 2003 |
| * | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug…Summary page 2…ON One Step Multi-Drug and Multi-Line Screen Test Card and Device K023946 ACON One Step Multi-Drug and Multi-Line Screen Test Card and Device K020313 Performance: The product performance characteristics of ACCUSTEP DOA Screen Panels were evaluated in the blind-labeled spiked co… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082977 | Bionexia Opticup Multi-Strip Doa Dipstick Test Integrated Cup | 2009 | 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 11 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K082977 (Mk Bio, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K023946.
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 Applied DNA Technologies ACCUSTEP DOA Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to ten of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows: Analyte Abbreviation Calibrator Cutoff Concentration Amphetamine AMP Amphetamine 1000 ng/ml Barbiturate BAR Secobarbital 300 ng/ml Benzodiazepines BZO…
Read the full statement (179 words)
The Applied DNA Technologies ACCUSTEP DOA Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to ten of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows:
Analyte Abbreviation Calibrator Cutoff Concentration
Amphetamine AMP Amphetamine 1000 ng/ml
Barbiturate BAR Secobarbital 300 ng/ml
Benzodiazepines BZO Oxazepam 300 ng/ml
Cocaine COC Benzoylecgonine 300 ng/ml
Marijuana THC i1-nor-A9 -THC9-COOH 50 ng/ml
Methamphetamine MET Methamphetamine 1000 ng/ml
Methadone MTD Methadone 300 nglml
Morphine MOR Morphine 2000 ng/ml
Phencyclidine PCP Phencyclidine 25 ng/ml
Nortriptyline NOR Nortriptyline 1000 ng/ml
These test kits are intended for health care professional use only.
This assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory method.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061005 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061005: Accustep Doa Single and Multi-Strip Screen Panels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061005
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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