510(k) · Cleared
ClearedAmeditech Immu Test Drug Screen Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ameditech, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Mar 8, 2004 after a 52-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Mar 8, 2004
- Review
- 52 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK040092 Ameditech Immu Test Drug Screen PanelAmeditech, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK113046 Ameditech Immutest Milti-Drug ScreenAmeditech, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK113501 Ameditech Checkcup Multi Drug Test (Flat/Round Cup)Ameditech, Inc. · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK051966 First Check Multi Drug Cup 7 for Marijuana (THC), Cocaine (Coc)…Worldwide Medical, LLC · 2005
Most influential descendants
Showing 3 of 3 · See all- K113046Ameditech Immutest Milti-Drug ScreenAmeditech, Inc. · 2011 · cites it directly1descendant
- K113501Ameditech Checkcup Multi Drug Test (Flat/Round Cup)Ameditech, Inc. · 2011 · 2 generations on0descendants
- K051966First Check Multi Drug Cup 7 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp)…Worldwide Medical, LLC · 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) | K040092 | Ameditech Immu Test Drug Screen Panel | Ameditech, Inc. | 2004 | — |
| +1 | K113046 | Ameditech Immutest Milti-Drug Screen | Ameditech, Inc. | 2011 | 84 |
| +2 | K113501 | Ameditech Checkcup Multi Drug Test (Flat/Round Cup) | Ameditech, Inc. | 2011 | 79 |
| +1 | K051966 | First Check Multi Drug Cup 7 for Marijuana (THC), Cocaine (Coc), Amphetamine… | Worldwide Medical, LLC | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 2 | 0 |
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 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K113046 (Ameditech, Inc., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, 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 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ameditech ImmuTest Drug Screen Panel is a one-step panel immunoassay for the qualitative detection of amphetamine, cocaine metabolite (benzoylecgonine), methamphetamine, opiates, phencyclidine, and THC in human urine. The cutoff concentrations for this panel test are amphetamine at 11000 ng/ml, cocaine metabolite at 300 ng/ml, methamphetamine at 500 ng/ml, opiates at 2000 ng/ml, phencyclidine at 25 ng/ml, and THC at 50 ng/ml.
This test kit is used to obtain a visual, qualitative results and is intended for professional use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040092: Ameditech Immu Test Drug Screen Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040092
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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