510(k) Report

510(k) · Cleared

Cleared

Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062

K033566510(k) TraditionalCleared May 17, 2004187-day reviewClass II21 CFR 862.3100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Descendants, by year cleared 2006: 1 descendant cleared2017: 1 descendant cleared200020052010201520202025
  1. This deviceK033566 Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062Rapid Diagnostics, Inc. · 2004
  2. Descendant · cites it directly · 1 of its ownK051958 MP Rapidoxy Test Strip, Model 07RD-7073Mp Biomedicals, LLC · 2006
  3. 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 all
  • K051958MP Rapidoxy Test Strip, Model 07RD-7073Mp Biomedicals, LLC · 2006 · cites it directly1descendant
  • K162395MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupMp Biomedicals, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K033566Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062Rapid Diagnostics, Inc.2004—
+1K051958MP Rapidoxy Test Strip, Model 07RD-7073Mp Biomedicals, LLC2006—
+1K162395MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupMp Biomedicals, LLC2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201710
FIG. 1 — Lineage of K033566, 2004–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

NumberDeviceApplicantDecidedDescendants
K051958MP Rapidoxy Test Strip, Model 07RD-7073Mp Biomedicals, LLC20061
K162395MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupMp Biomedicals, LLC20170

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 devices

DKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DKZ

1in 2024

2008: 22009: 22010: 42011: 62012: 52013: 82014: 82015: 52016: 52018: 32019: 32020: 12023: 22024: 1
2007high 8 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DKZ

180in 2019

2010: 233 days median2011: 123 days median2012: 55 days median2013: 103 days median2014: 128 days median2015: 107 days median2016: 215 days median2018: 128 days median2019: 180 days median
2007high 233 (2010) · low 55 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DKZ

1in 2017

2007: 12008: 32009: 52011: 42013: 12014: 32017: 1
2007high 5 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DKZ

2in 2025

2008: 122009: 12010: 12011: 22013: 12014: 92015: 82016: 82021: 32022: 42023: 72024: 12025: 2
2007high 12 (2008) · low 0 (2007)2025

MAUDE reports naming product code DKZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—10
20082—312
20092—51
2010423301
2011612342
201255500
2013810311
2014812839
2015510708
2016521508
20170—10
2018312800
2019318000
20201—00
20210—03
20220—04
20232—07
20241—01
20250—02
20260—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.

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