510(k) Report

510(k) · Cleared

Cleared

Rapid Drugs of Abuse Single and Multiple Test Panels

K003809510(k) TraditionalCleared Apr 20, 2001133-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 Apr 20, 2001 after a 133-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Apr 20, 2001
Review
133 days
Class
Class II
Product code
DKZ
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared200020052010201520202025
  1. This deviceK003809 Rapid Drugs of Abuse Single and Multiple Test PanelsRapid Diagnostics, Inc. · 2001
  2. 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 1 of 1 · See all
  • 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)K003809Rapid Drugs of Abuse Single and Multiple Test PanelsRapid Diagnostics, Inc.2001—
+1K162395MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupMp Biomedicals, LLC2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K003809, 2001–2017Source: 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), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
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, K162395 (Mp Biomedicals, LLC, 2017) has gone furthest, with 0 descendants 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—

More from Rapid Diagnostics, Inc.

4 FDA decisions under this applicant name. See the company

  • K033566Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062Rapid Diagnostics, Inc. · 2004
  • K020716Rapid Opiates Test Strip II, Rapid Opiates Test Card II and Doa Multiple Drug Test Cards (UP to Six Tests)Rapid Diagnostics, Inc. · 2002
  • K981770Rapidhcg Pregnancy TestRapid Diagnostics, Inc. · 1998

Recent decisions in DKZ

The DKZ category page

  • K240670DRI Ecstasy Plus AssayMicrogenics Corporation · 2024
  • K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup…Hangzhou AllTest Biotech Co., Ltd. · 2023
  • K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd. · 2023
  • K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc. · 2020
  • K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas Medical · 2019

https://510kreport.com/device/K003809 · printed Nov 3, 2026

Cite this page

510(k) Report. “K003809: Rapid Drugs of Abuse Single and Multiple Test Panels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K003809

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026