510(k) · Cleared

Cleared

Drug Stop

K991465510(k) TraditionalCleared Dec 10, 1999227-day reviewClass U

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

Texas Immunology, Inc. · MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter

Cleared on Dec 10, 1999 after a 227-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Dec 10, 1999
Review: 227 days
Class: Class U
Product code: MVO
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K991465Source: FDA 510(k) database · How lineage is built

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 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’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 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

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

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

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	1
2008	—	0	1
2009	—	0	2
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	3
2014	—	0	0
2015	—	0	1
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	1	—

What is it indicated for?

DrugStop is an at home drug screening test and if necessary a confirmation service. This product is a preliminary screen to detect and identify the presence of drugs within the body using a urine sample. The device is designed to detect the presence of COC (Cocain, Crack), THC (Marijuana, Pot, Cannabis), MOR (Opiates, Herion, Morphine), AMP (Amphetamine, Speed, Methamphetamine), PCPC (Angel Dust). ) DrugStop is the first step in a tvo step testing…

Read the full statement (144 words)

DrugStop is the first step in a tvo step testing proceas. If a result is NEGATIVE, then, the person being tested probably does not have that drug in their body. HOWEVER, if the result is PRELIMINARY, the sample MUST be sent to our reference lab for confirmation at no additional cost to the customer. Howme drug tests are not as accurate as lab tests and any PRELIMINARY results MUST BE CONFIRMED before any action is taken against the person being tested.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K991465 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991465: Drug Stop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991465

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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