510(k) · Cleared
ClearedMethadone Metabolite Eia Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Reagents, Inc. · DJR Enzyme Immunoassay, Methadone
Cleared on Aug 23, 1993 after a 136-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.
- Decided
- Aug 23, 1993
- Review
- 136 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK931780 Methadone Metabolite Eia AssayDiagnostic Reagents, Inc. · 1993
- Descendant · cites it directly · 5 of its ownK023617 Dri Methadone Metabolite Enzyme ImmunoassayMicrogenics Corp. · 2003
- Descendant · 2 generations on · 3 of its ownK151395 Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP…Immunalysis Corporation · 2015 · Recalled
- Descendant · cites it directly · 2 of its ownK980746 Cedia Dau Eddp AssayBoehringer Mannheim Corp. · 1998
- Descendant · 3 generations on · 1 of its ownK182719 Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK081378 Dri Methadone Metabolite (100/300) Assay, Calibrators and ControlsThermo Fisher Scientific · 2009
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K023617Dri Methadone Metabolite Enzyme ImmunoassayMicrogenics Corp. · 2003 · cites it directly5descendants
- K151395Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators…Immunalysis Corporation · 2015 · 2 generations on3descendants
- K980746Cedia Dau Eddp AssayBoehringer Mannheim Corp. · 1998 · cites it directly2descendants
- K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc. · 2019 · 3 generations on1descendant
- K081378Dri Methadone Metabolite (100/300) Assay, Calibrators and ControlsThermo Fisher Scientific · 2009 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931780 | Methadone Metabolite Eia Assay | Diagnostic Reagents, Inc. | 1993 | — |
| +1 | K023617 | Dri Methadone Metabolite Enzyme Immunoassay | Microgenics Corp. | 2003 | — |
| +2 | K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine… | Immunalysis Corporation | 2015 | 1 |
| +1 | K980746 | Cedia Dau Eddp Assay | Boehringer Mannheim Corp. | 1998 | — |
| +3 | K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | Quidel Cardiovascular, Inc. | 2019 | — |
| +2 | K081378 | Dri Methadone Metabolite (100/300) Assay, Calibrators and Controls | Thermo Fisher Scientific | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (10)
3 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?
- Of its descendants, K023617 (Microgenics Corp., 2003) has gone furthest, with 5 descendants of its own.
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 | — |
https://510kreport.com/device/K931780 · printed Nov 6, 2026
Cite this page
510(k) Report. “K931780: Methadone Metabolite Eia Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931780
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026