510(k) · Cleared
Recalled · 2011Ameditech Immutest Multi-Drug Screen Panel II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ameditech, Inc. · DIS Enzyme Immunoassay, Barbiturate
Cleared on Dec 29, 2004 after a 62-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 29, 2004
- Review
- 62 days
- Class
- Class II
- Product code
- DIS
- Recalls
- 3
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK042975 Ameditech Immutest Multi-Drug Screen Panel IIAmeditech, 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) | K042975 | Ameditech Immutest Multi-Drug Screen Panel II | 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 DIS? 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?
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)
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, K113046 (Ameditech, Inc., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DIS devicesDIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIS
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIS
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIS
1in 2018
MAUDE reports naming product code DIS, 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 | 3 | 331 | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 29 | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 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 | — | 0 | — |
What is it indicated for?
The Ameditech ImmuTest Multi-Drug Screen Panel Il 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) Barbiturates (BAR) — Secobarbital — 300 Benzodiazepines (BZO) — Oxazepam — 300 3,4methylenedioxymethamphetamine (MDMA) — 3,4methylenedioxymethamphetamine — 500 Methamphetamine (MET1000) — d-Methamphetamine — 1000…
Read the full statement (193 words)
The Ameditech ImmuTest Multi-Drug Screen Panel Il 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)
Barbiturates (BAR) — Secobarbital — 300
Benzodiazepines (BZO) — Oxazepam — 300
3,4methylenedioxymethamphetamine (MDMA) — 3,4methylenedioxymethamphetamine — 500
Methamphetamine (MET1000) — d-Methamphetamine — 1000
Methadone (MTD) — Methadone — 300
Opiates (OPI300) — Morphine — 300
Oxycodone (OXY) — Oxycodone — 100
This test has three types of test format: 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 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 Spectroscopy (GC/MS) is the preferred confirmation method
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042975: Ameditech Immutest Multi-Drug Screen Panel II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042975
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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