510(k) · Cleared
ClearedOne Step Drug Test - Amp/Met/Mor/THC/Coc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ind Diagnostic, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Aug 7, 2006 after a 136-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 7, 2006
- Review
- 136 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
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 One Step Drugs of Abuse Test is a prescription lateral flow competitive immunoassay panel or single test intended for professional central laboratory use by trained users. It provides qualitative visual screening results for Marijuana, Cocaine, Morphine, Amphetamine and Methamphetamine at cutoff concentrations of 50 ng/mln Marijuana, 300 ng/mL Cocaine, 300 ng/mL Morphine, 1000 ng/mL Amphetamine and 1000 ng/mL Methamphetainine in urine in combinations…
Read the full statement (144 words)
The One Step Drugs of Abuse Test is a prescription lateral flow competitive immunoassay panel or single test intended for professional central laboratory use by trained users. It provides qualitative visual screening results for Marijuana, Cocaine, Morphine, Amphetamine and Methamphetamine at cutoff concentrations of 50 ng/mln Marijuana, 300 ng/mL Cocaine, 300 ng/mL Morphine, 1000 ng/mL Amphetamine and 1000 ng/mL Methamphetainine in urine in combinations (Multi-Panel) or separately (Single). It is not intended for over the counter sales to the lay person.
For in vitro diagnostic use only.
As with all qualitative tests, this assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K060810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060810: One Step Drug Test - Amp/Met/Mor/THC/Coc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060810
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026