510(k) · Cleared
Recalled · 2011Ameditech Drugsmartcup
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 Dec 8, 2005 after a 24-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 8, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK053175 Ameditech DrugsmartcupAmeditech, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK113501 Ameditech Checkcup Multi Drug Test (Flat/Round Cup)Ameditech, Inc. · 2011 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K113501Ameditech Checkcup Multi Drug Test (Flat/Round Cup)Ameditech, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053175 | Ameditech Drugsmartcup | Ameditech, Inc. | 2005 | — |
| +1 | K113501 | Ameditech Checkcup Multi Drug Test (Flat/Round Cup) | Ameditech, Inc. | 2011 | 79 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113501 | Ameditech Checkcup Multi Drug Test (Flat/Round Cup) | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 18, 2011 | Not classified | Z-2387-2011 | Incorrect or no expiration date | Express Diagnostics Int'l, Inc. has initiated a medical device recall on various model numbers of DrugCheck devices, This recall was due to incorrect product expiration dating after findings from an FDA inspection. Use of expired product… |
| Nov 1, 2010 | Not classified | Z-3104-2011 | Error in labeling | Express Diagnostics Intl'l Inc is recalling DrugCheck devices because they were informed via letter from the alcohol test strip manufacturer on October 27, 2010 that the product was not 510 K cleared for in vitro diagnostic use and could… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113501 (Ameditech, Inc., 2011) has gone furthest, with 0 descendants 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 DrugSmartCupTM is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this test are as follows. Test | Calibrator | Cutoff Amphetamine (AMP) | Amphetamine | 1000 Barbiturates (BAR) | Secobarbital | 300 Cocaine metabolite (COC) | Benzoylecgonine | 300 Benzodiazepines (BZO) | Oxazepam | 300 3,4methylenedioxymethamphetamine (MDMA) | 3,4methylenedioxymethamphetamine | 500…
Read the full statement (182 words)
The Ameditech DrugSmartCupTM is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this test are as follows.
Test | Calibrator | Cutoff
Amphetamine (AMP) | Amphetamine | 1000
Barbiturates (BAR) | Secobarbital | 300
Cocaine metabolite (COC) | Benzoylecgonine | 300
Benzodiazepines (BZO) | Oxazepam | 300
3,4methylenedioxymethamphetamine (MDMA) | 3,4methylenedioxymethamphetamine | 500
Methamphetamine (MET) | Methamphetamine | 1000
Methadone (MTD) | Methadone | 300
Opiates (OP1300) | Morphine | 300
Opiates (OP[2000) | Morphine | 2000
Oxycodone (OXY) | Oxycodone | 100
Phencyclidine (PCP) | Phencyclidine | 25
Tricyclic Antidepressants (TCA) | Nortriptyline | 1000
Tetrahydrocannabinol (THC) | I l-nor-A9-THC-9-COOH | 50
This test is used to obtain a visual, qualitative result and is intended for professional use.
This assay provides only a preliminary result Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result In order to obtain a confirmed analytical result, a more specific alternatech nical method is needed Gas Chromatography/MassSpectroscopy (GC/MS) is the prerredconfirmation method.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K053175 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053175: Ameditech Drugsmartcup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053175
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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