510(k) · Cleared
ClearedDri Methadone Metabolite (100/300) Assay, Calibrators and Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Fisher Scientific · DJR Enzyme Immunoassay, Methadone
Cleared on Jan 14, 2009 as substantially equivalent to K980746 (Boehringer Mannheim Corp., 1998) and 2 other predicates after a 243-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Jan 14, 2009
- Review
- 243 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K931780 (1993). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK931780 Methadone Metabolite Eia AssayDiagnostic Reagents, Inc. · 1993
- 1 generation backK980746 Cedia Dau Eddp AssayBoehringer Mannheim Corp. · 1998
- This deviceK081378 Dri Methadone Metabolite (100/300) Assay, Calibrators and ControlsThermo Fisher Scientific · 2009
- Descendant · cites it directly · 0 of its ownK092048 One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated · 2010
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −2 | K931780 | Methadone Metabolite Eia Assay | Diagnostic Reagents, Inc. | 1993 | — |
| −1 | K980746 | Cedia Dau Eddp Assay | Boehringer Mannheim Corp. | 1998 | — |
| 0 (this device) | K081378 | Dri Methadone Metabolite (100/300) Assay, Calibrators and Controls | Thermo Fisher Scientific | 2009 | — |
| +1 | K092048 | One Step Eddp (Methadone Metabolite) Test Strip | Biosite Incorporated | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K980746 | Cedia Dau Eddp AssaySummary page 2…MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED The DRI Methadone Metabolite (100/300) Assay is substantially equivalent to the previously cleared CEDIA DAU EDDP Assay (K980746, Microgenics Corporation). The DRI Methadone Metabolite Calibrators are substantially equivalent to the previously cleared CEDIA… | 1998 |
| * | K980853 | Cedia Dau Multi-Drug CalibratorsSummary page 2…ay (K980746, Microgenics Corporation). The DRI Methadone Metabolite Calibrators are substantially equivalent to the previously cleared CEDIA DAU Multi-Drug Calibrators (K980853, Microgenics Corporation). The DRI Methadone Metabolite Controls are substantially equivalent to the previously cleared MGC DAU… | 1998 |
| * | K040758 | MGC Dau Control Sets: Primary, Clinical and SelectSummary page 2…Microgenics Corporation). The DRI Methadone Metabolite Controls are substantially equivalent to the previously cleared MGC DAU Control Sets: Primary, Clinical, Select (K040758, Microgenics Corporation). DESCRIPTION OF DEVICE The DRI Methadone Metabolite (100/300) Assay utilizes liquid ready-to-use reage… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092048 | One Step Eddp (Methadone Metabolite) Test Strip | 2010 | 0 |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K092048 (Biosite Incorporated, 2010) has gone furthest, with 0 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. 2009, this device’s year, is highlighted.
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 DRI Methadone Metabolite (1001300) Assay is intended for the qualitative and semi-quantitative determination of the presence of Methadone Metabolite (2-ethylidene-1,,5-dimethyl-3,3-diphenylpyrrolidine or EDDP) in human urine at cutoffs of 100 and 300 ng/mL. The DRI Methadone Metabolite Calibrators are intended for use in calibration of the DRI Methadone Metabolite (100/300) Assay. The DRI Methadone Metabolite Controls are intended for use in the DRI…
Read the full statement (164 words)
The DRI Methadone Metabolite (1001300) Assay is intended for the qualitative and semi-quantitative determination of the presence of Methadone Metabolite (2-ethylidene-1,,5-dimethyl-3,3-diphenylpyrrolidine or EDDP) in human urine at cutoffs of 100 and 300 ng/mL.
The DRI Methadone Metabolite Calibrators are intended for use in calibration of the DRI Methadone Metabolite (100/300) Assay.
The DRI Methadone Metabolite Controls are intended for use in the DRI Methadone Metabolite (100/300) Assay to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography / Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. Tests for-methadone metabolite cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for methadone metabolite and cause false positive results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081378: Dri Methadone Metabolite (100/300) Assay, Calibrators and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081378
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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