510(k) Report

510(k) · Cleared

Cleared

Modification to at Home Drug Test, Models 9150, 9068, and 9175

K003858510(k) TraditionalCleared Feb 12, 200161-day reviewClass U

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

Phamatech · MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter

Cleared on Feb 12, 2001 after a 61-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
Feb 12, 2001
Review
61 days
Class
Class U
Product code
MVO
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared200020052010201520202025
  1. This deviceK003858 Modification to at Home Drug Test, Models 9150, 9068, and 9175Phamatech · 2001
  2. Descendant · cites it directly · 0 of its ownK040629 Accu-Stat Home Drug Test for Marijuana, Cocaine, Amphetamine…Accu-Stat Diagnostics, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all
  • K040629Accu-Stat Home Drug Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates…Accu-Stat Diagnostics, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003858Modification to at Home Drug Test, Models 9150, 9068, and 9175Phamatech2001—
+1K040629Accu-Stat Home Drug Test for Marijuana, Cocaine, Amphetamine, Methamphetamine…Accu-Stat Diagnostics, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K003858, 2001–2004Source: 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 MVO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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
K040629Accu-Stat Home Drug Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates…Accu-Stat Diagnostics, Inc.20040

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, K040629 (Accu-Stat Diagnostics, Inc., 2004) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MVO devices

MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MVO

FDA has decided no MVO device since 2007.

Median 510(k) review, days · MVO

Too few MVO 510(k)s in any year since 2007 to give a median.

Recalls per year · MVO

1so far in 2026, the most since 2007

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

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

Adverse event reports per year · MVO

1in 2015

2007: 12008: 12009: 22013: 32015: 1
2007high 3 (2013) · low 0 (2010)2025

MAUDE reports naming product code MVO, 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—01
20080—01
20090—02
20100—00
20110—00
20120—00
20130—03
20140—00
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—1—

More from Phamatech

47 FDA decisions under this applicant name. See the company

  • K041578Quickscreen, Models 9177X and 9178XPhamatech · 2004
  • K030447AT Home Drug Cup, Model 9150XPhamatech · 2003
  • K010833AT Work Drug Test, Model 9177T AwtPhamatech · 2001
  • K010836AT Work Drug Test, Model 9147T AwtPhamatech · 2001
  • K010654AT Home Drug Test, Model 9078 TPhamatech · 2001

Recent decisions in MVO

The MVO category page

  • K040327Accu-Stat Home Drug Tests for Marijuana (THC) and for Marijuana & Cocaine (THC, Coc)Accu-Stat Diagnostics, Inc. · 2004
  • K030447AT Home Drug Cup, Model 9150XPhamatech · 2003
  • K014192Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status DS MetPrinceton BioMeditech Corp. · 2002
  • K013778Peace of Mind Home Drug TestAdvantage Diagnostics Corp. · 2002
  • K013409AT Home Drug Test, Model 9074Phamatech, Inc. · 2001

https://510kreport.com/device/K003858 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003858: Modification to at Home Drug Test, Models 9150, 9068, and 9175.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003858

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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