510(k) · Cleared
Recalled · 2011Ameditech Immutest Multi-Drug Screen Bup/PPX/COC150
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ameditech, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Dec 20, 2006 after a 79-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 20, 2006
- Review
- 79 days
- Class
- Class II
- Product code
- DJG
- Recalls
- 2
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK063015 Ameditech Immutest Multi-Drug Screen Bup/PPX/COC150Ameditech, Inc. · 2006
- 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063015 | Ameditech Immutest Multi-Drug Screen Bup/PPX/COC150 | Ameditech, Inc. | 2006 | — |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113046 | Ameditech Immutest Milti-Drug Screen | 2011 | 1 |
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, K113046 (Ameditech, Inc., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
The Ameditech ImmuTest Multi-Drug Screen BUP/PPX/COC150 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) Buprenorphine (BUP) Buprenorphine 10 Propoxyphene (PPX) Propoxyphene 300 Cocaine metabolite (COC 150) Benzoylecgonine 150 This test uses multiple test strips in card format (test strips are placed in a card strip…
Read the full statement (159 words)
The Ameditech ImmuTest Multi-Drug Screen BUP/PPX/COC150 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)
Buprenorphine (BUP) Buprenorphine 10
Propoxyphene (PPX) Propoxyphene 300
Cocaine metabolite (COC 150) Benzoylecgonine 150
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 assay provides only a preliminary result Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularlyin evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical 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/K063015 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063015: Ameditech Immutest Multi-Drug Screen Bup/PPX/COC150.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063015
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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