510(k) · Cleared
ClearedAccu-Stat Home Drug Tests for Marijuana (THC) and for Marijuana & Cocaine (THC, Coc)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accu-Stat Diagnostics, Inc. · MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Cleared on Apr 19, 2004 after a 69-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Apr 19, 2004
- Review
- 69 days
- Class
- Class U
- Product code
- MVO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK040327 Accu-Stat Home Drug Tests for Marijuana (THC) and for Marijuana &…Accu-Stat Diagnostics, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK050936 ON Call Home Drug Test for Marijuana and on Call Home Drug Test for…ACON Laboratories, Inc. · 2005
Most influential descendants
Showing 1 of 1 · See all- K050936ON Call Home Drug Test for Marijuana and on Call Home Drug Test for Marijuana and CocaineACON Laboratories, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040327 | Accu-Stat Home Drug Tests for Marijuana (THC) and for Marijuana & Cocaine… | Accu-Stat Diagnostics, Inc. | 2004 | — |
| +1 | K050936 | ON Call Home Drug Test for Marijuana and on Call Home Drug Test for Marijuana… | ACON Laboratories, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | First Check Home Drug Test for THC (Marijuana) Named without a submission number | |
| * | — | Phamatech At Home Drug Test for Marijuana Named without a submission number | |
| * | — | First Check Home Drug Test for Marijuana and Cocaine Named without a submission number | |
| † | K003557 | Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step Marijuana Test Device… | 2001 |
| † | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050936 | ON Call Home Drug Test for Marijuana and on Call Home Drug Test for Marijuana and Cocaine | 2005 | 0 |
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, K050936 (ACON Laboratories, Inc., 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MVO devicesMVO 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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVO
1in 2015
MAUDE reports naming product code MVO, 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 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Accu-StatTM Home Drug Test for Marijuana (THC) is a screening test for the rapid detection of THC and its metabolites in human urine at a cut-off level of 50 ng/ml. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence or absence of THC or its metabolites in a urine sample. Information, along with the materials for shipping a portion of the…
Read the full statement (214 words)
The Accu-StatTM Home Drug Test for Marijuana (THC) is a screening test for the rapid detection of THC and its metabolites in human urine at a cut-off level of 50 ng/ml. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence or absence of THC or its metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.
The Accu-StatTM Home Drug Test for Marijuana and Cocaine (THC, COC) is a screening test for the rapid detection of THC and/or COC and its metabolites in human urine at a cut-off level of 50 ng/ml for THC and 300 ng/ml for COC. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence or absence of either THC, COC (or their metabolites) in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040327 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040327: Accu-Stat Home Drug Tests for Marijuana (THC) and for Marijuana & Cocaine (THC, Coc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040327
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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