510(k) · Cleared
Recalled · 2011Ameditech Immutest Multi-Drug Screen Panel Iii
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 4, 2005 after a 36-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 21 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 4, 2005
- Review
- 36 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- 3
- Predicates
- 0
21 later devices descend from it, 2 citing it directly.
- This deviceK050186 Ameditech Immutest Multi-Drug Screen Panel IiiAmeditech, Inc. · 2005
- Descendant · cites it directly · 18 of its ownK052115 First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc)…First Check Diagnostics, LLC · 2005 · Recalled
- Descendant · 2 generations on · 4 of its ownK143187 Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen…Healgen Scientific,, LLC · 2015
- Descendant · 2 generations on · 4 of its ownK142280 Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen…Healgen Scientific,, LLC · 2014
- Descendant · 2 generations on · 4 of its ownK141647 Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip…Healgen Scientific,, LLC · 2014
- Descendant · 2 generations on · 4 of its ownK140546 Healgen THC One Step Marijuana Test , Healgen Mamp One Step…Healgen Scientific,, LLC · 2014 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K052115First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp)…First Check Diagnostics, LLC · 2005 · cites it directly18descendants
- K143187Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test…Healgen Scientific,, LLC · 2015 · 2 generations on4descendants
- K142280Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip…Healgen Scientific,, LLC · 2014 · 2 generations on4descendants
- K141647Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip (Cassette, Cup, Dip Card)Healgen Scientific,, LLC · 2014 · 2 generations on4descendants
- K140546Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine TestHealgen Scientific,, LLC · 2014 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050186 | Ameditech Immutest Multi-Drug Screen Panel Iii | Ameditech, Inc. | 2005 | — |
| +1 | K052115 | First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine… | First Check Diagnostics, LLC | 2005 | 86 |
| +2 | K143187 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone… | Healgen Scientific,, LLC | 2015 | — |
| +2 | K142280 | Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test… | Healgen Scientific,, LLC | 2014 | — |
| +2 | K141647 | Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip (Cassette, Cup… | Healgen Scientific,, LLC | 2014 | — |
| +2 | K140546 | Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine Test | Healgen Scientific,, LLC | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (21)
See all 212 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 26, 2011 | Not classified | Z-2670-2011 | Process control | The recall was initiated because Ameditech's internal review of regulatory files found that the two affected lots were manufactured without proper regulatory clearance. |
| 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, K052115 (First Check Diagnostics, LLC, 2005) has gone furthest, with 18 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 ImmuTest Multi-Drug Screen Panel III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows. Test — Calibrator — Cutoff (ng/ml) Cocaine metabolite (COC) — Benzoylecgonine — 300 Tetrahydrocannabinol (THC) — I l-nor-A9-THC-9-COOH — 50 Methamphetamine (MET 1000) — Methamphetamine — 1000 Opiates (OPI) — Morphine — 2000 Phencyclidine (PCP) —…
Read the full statement (217 words)
The Ameditech ImmuTest Multi-Drug Screen Panel III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows.
Test — Calibrator — Cutoff (ng/ml)
Cocaine metabolite (COC) — Benzoylecgonine — 300
Tetrahydrocannabinol (THC) — I l-nor-A9-THC-9-COOH — 50
Methamphetamine (MET 1000) — Methamphetamine — 1000
Opiates (OPI) — Morphine — 2000
Phencyclidine (PCP) — Phencyclidine — 25
Amphetamine (AMP) — Amphetamine — 1000
Barbiturates (BAR) — Secobarbital — 300
Benzodiazepines (BZO) — Oxazepam — 300
Methadone (MTD) — Methadone — 300
Tricyclic Antidepressants (TCA) — Nortriptyline — 1000
Oxycodone (OXY) — Oxycodone — 100
3,4methylenedioxymethamphetamine (MDMA) — 3,4methylenedioxymethamphetamine — 500
This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder).
This test is used to obtain a visual, qualitative result and is intended for professional use.
This assayprovides only a preliminary result. Clinical considerationandprofessional judgment must be applied to any drug of abuse test result, particularlyin evaluating a preliminarypositive result.In order to obtain a confirmed analyticalresult, a more specific alternatechemical method is needed. Gas Chromatography/MassSpectroscopy (GC/MS) is the preferred confirmation method.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050186: Ameditech Immutest Multi-Drug Screen Panel Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050186
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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