510(k) · Cleared
ClearedMicromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rapid Diagnostics, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on May 17, 2004 after a 187-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- May 17, 2004
- Review
- 187 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK033566 Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062Rapid Diagnostics, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK051958 MP Rapidoxy Test Strip, Model 07RD-7073Mp Biomedicals, LLC · 2006
- Descendant · cites it directly · 0 of its ownK162395 MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupMp Biomedicals, LLC · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033566 | Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062 | Rapid Diagnostics, Inc. | 2004 | — |
| +1 | K051958 | MP Rapidoxy Test Strip, Model 07RD-7073 | Mp Biomedicals, LLC | 2006 | — |
| +1 | K162395 | MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup | Mp Biomedicals, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2017 | 1 | 0 |
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? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K051958 (Mp Biomedicals, LLC, 2006) has gone furthest, with 1 descendant 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 MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine at the following cut-off levels (amphetamine, 1000 ng/ml; barbiturate [secobarbitall, 300 ng/ml; benzodiazepine loxazepaml, 300 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 2000 ng/ml; phencyclidine, 25 ng/ml; and…
Read the full statement (229 words)
The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine at the following cut-off levels (amphetamine, 1000 ng/ml; barbiturate [secobarbitall, 300 ng/ml; benzodiazepine loxazepaml, 300 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 2000 ng/ml; phencyclidine, 25 ng/ml; and cannabinoid, 50 ng/ml).
The MICROMEDIC® Drugs of Abuse Panel Test is intended for use in a point-of-care (POC) setting to include emergency hospitals and medical care facilities (i.e., emergency rooms, ambulances, etc.), as well as the workplace, criminal justice and transportation arenas, and walk-in, or mobile drug testing facilities. The MICROMEDIC® Drugs of Abuse Panel Test will provide 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) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. It is the responsibility of those organizations required to follow Department of Transportation (DOT) or the Substance Abuse and Mental Health Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfies the criteria for workplace testing established under DOT and SAMHSA.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033566: Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033566
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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