510(k) · Cleared
ClearedDri Methadone Metabolite Enzyme Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · DJR Enzyme Immunoassay, Methadone
Cleared on Aug 27, 2003 as substantially equivalent to K931780 (Diagnostic Reagents, Inc., 1993) after a 302-day review. Its family tree reaches back 1 generation to 1993. 5 later devices descend from it.
- Decided
- Aug 27, 2003
- Review
- 302 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931780 (1993). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931780 Methadone Metabolite Eia AssayDiagnostic Reagents, Inc. · 1993
- This deviceK023617 Dri Methadone Metabolite Enzyme ImmunoassayMicrogenics Corp. · 2003
- Descendant · cites it directly · 3 of its ownK151395 Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP…Immunalysis Corporation · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK182719 Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK200363 Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK182779 ARK EDDP AssayArk Diagnostics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK092048 One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated · 2010
Most influential descendants
Showing 5 of 5 · See all- K151395Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators…Immunalysis Corporation · 2015 · cites it directly3descendants
- K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc. · 2019 · 2 generations on1descendant
- K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc. · 2020 · 3 generations on0descendants
- K182779ARK EDDP AssayArk Diagnostics, Inc. · 2018 · 2 generations on0descendants
- K092048One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931780 | Methadone Metabolite Eia Assay | Diagnostic Reagents, Inc. | 1993 | — |
| 0 (this device) | K023617 | Dri Methadone Metabolite Enzyme Immunoassay | Microgenics Corp. | 2003 | — |
| +1 | K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine… | Immunalysis Corporation | 2015 | 1 |
| +2 | K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | Quidel Cardiovascular, Inc. | 2019 | — |
| +3 | K200363 | Quidel Triage® TOX Drug Screen, 94600 | Quidel Cardiovascular, Inc. | 2020 | — |
| +2 | K182779 | ARK EDDP Assay | Ark Diagnostics, Inc. | 2018 | — |
| +1 | K092048 | One Step Eddp (Methadone Metabolite) Test Strip | Biosite Incorporated | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 DJR? 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? (1)
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 |
|---|---|---|---|
| * | K931780 | Methadone Metabolite Eia AssaySummary page 1…Methadone Metabolite Assay Legally Marketed Predicate Device: The subject DRI@Methadone Metabolite Enzyme Assay is substantially equivalent to the previously cleared (K93 1780) predicate DRI? Methadone Metabolite Enzyme Assay cleared. The subject DRI@Methadone Metabolite Enzyme Assay is identical or simi… | 1993 |
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DJR devicesDJR Enzyme Immunoassay, Methadone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJR
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · DJR
59in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJR
1in 2025
MAUDE reports naming product code DJR, 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 | — | 0 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 3 | 469 | 1 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 3 | 59 | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 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 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Methadone Metabolite Immunoassay is intended to be used for the qualitative and semiquantitative determination of the presence of Methadone Metabolite (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine or EDDP) in human urine at cutoffs of 300 and 1000 ng/mL. The semiquantitative range of the assay is 31-2000 ng/mL. The assay provides a simple and rapid analytical screening procedure to detect methadone metabolite in human urine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023617: Dri Methadone Metabolite Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023617
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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