510(k) · Cleared
Recalled · Class II · 2020Ameditech Immutest Milti-Drug Screen
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 Nov 10, 2011 as substantially equivalent to K050186 (Ameditech, Inc., 2005) and 3 other predicates after a 28-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it. It has been recalled 84 times.
- Decided
- Nov 10, 2011
- Review
- 28 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- 84
- Predicates
- 4
Its longest line of descent runs back 1 generation to K040092 (2004). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK040092 Ameditech Immu Test Drug Screen PanelAmeditech, Inc. · 2004
- This deviceK113046 Ameditech Immutest Milti-Drug ScreenAmeditech, Inc. · 2011
- 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 |
|---|---|---|---|---|---|
| −1 | K040092 | Ameditech Immu Test Drug Screen Panel | Ameditech, Inc. | 2004 | — |
| 0 (this device) | K113046 | Ameditech Immutest Milti-Drug Screen | Ameditech, Inc. | 2011 | — |
| +1 | K113501 | Ameditech Checkcup Multi Drug Test (Flat/Round Cup) | Ameditech, Inc. | 2011 | 79 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 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? (4)
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 |
|---|---|---|---|
| * | K050186 | Ameditech Immutest Multi-Drug Screen Panel IiiSummary page 1…Drug Screen Dipcard Ameditech ImmuTest Multi-Drug Screen Cassette Ameditech ImmuTest Multi-Drug Screen Cup Predicates: Ameditech ImmuTest Multi-Drug Screen Panel 1ll (K050186) C. Device Description: The Ameditech ImmuTest Multi-Drug Screen is a lateral flow immunoassay intended for professional (presc… | 2005 |
| * | K040092 | Ameditech Immu Test Drug Screen PanelSummary page 2…ds. E. Comparison with the Predicate The modified device isidentical to the cleared predicates referenced above (KOSO186). The drug strips cleared by FDA in submissions K040092, K(042975, and K(063015 will be consolidated into a single device. The purpose of this submission isto cover all the drug strips… | 2004 |
| * | K042975 | Ameditech Immutest Multi-Drug Screen Panel IISummary page 2…parison with the Predicate The modified device isidentical to the cleared predicates referenced above (KOSO186). The drug strips cleared by FDA in submissions K040092, K(042975, and K(063015 will be consolidated into a single device. The purpose of this submission isto cover all the drug strips and their… | 2004 |
| * | K063015 | Ameditech Immutest Multi-Drug Screen Bup/PPX/COC150Summary page 2…he Predicate The modified device isidentical to the cleared predicates referenced above (KOSO186). The drug strips cleared by FDA in submissions K040092, K(042975, and K(063015 will be consolidated into a single device. The purpose of this submission isto cover all the drug strips and their respective cut… | 2006 |
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 |
|---|---|---|---|---|
| Aug 18, 2020 | Class II | Z-3051-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Aug 18, 2020 | Class II | Z-3042-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Aug 18, 2020 | Class II | Z-3036-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Nov 16, 2015 | Class III | Z-0511-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0512-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0542-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0520-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0517-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0536-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0527-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0530-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0503-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0487-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0518-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0486-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0514-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0521-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0534-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0532-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0529-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0502-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0505-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0496-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0501-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0488-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0500-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0509-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0493-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0504-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0497-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0516-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0484-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0522-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0498-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0524-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0523-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0515-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0525-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0519-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0507-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0541-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0499-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0528-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0489-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0485-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0491-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0492-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0510-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0508-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0506-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 ImmuTest Multi-Drug Screen is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations: Test Calibrator Cut-off (ng/ml) AMP d-Amphetamine 1000 BAR Secobarbital 300 SUPD Buprenorphine 10 BZO Oxazepam 300 COC 150 Benzoylecgonine 150 CCC Benzoylecgonine 300 MVDMA 3,4-methylenedioxymethamphetamine *500 MET 500 d-Methamphetamine 500 MET d-Methamphetamine 1000 MTD…
Read the full statement (190 words)
The ImmuTest Multi-Drug Screen is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations:
Test Calibrator Cut-off (ng/ml)
AMP d-Amphetamine 1000
BAR Secobarbital 300
SUPD Buprenorphine 10
BZO Oxazepam 300
COC 150 Benzoylecgonine 150
CCC Benzoylecgonine 300
MVDMA 3,4-methylenedioxymethamphetamine *500
MET 500 d-Methamphetamine 500
MET d-Methamphetamine 1000
MTD dI-Methadone 300
OPI 300 Morphine 300
OPI Morphine 2000
OXY Oxycodone 100
PCP Phencyclidline 25
PPX Propoxyphene 300
TCA Nortriptyline 1000
THC 11-nor-A9-THC-9-COOH 50
The ImmuTest Multi-Drug Screen consists of three test formats: card, cassette and cup. The configurations of the ImmuTest Multi-Drug Screen consist of any combination of the drugs listed above. The ImmuTest Multi-Drug Screen is used to obtain a visual, qualitative result and is intended for professional use only.
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 alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/fWS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113046: Ameditech Immutest Milti-Drug Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113046
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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