510(k) · Cleared
ClearedOne Step Eddp (Methadone Metabolite) Test Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosite Incorporated · DJR Enzyme Immunoassay, Methadone
Cleared on Apr 19, 2010 as substantially equivalent to K012595 (ACON Laboratories, Inc., 2001) and 2 other predicates after a 286-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Apr 19, 2010
- Review
- 286 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K931780 (1993). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK931780 Methadone Metabolite Eia AssayDiagnostic Reagents, Inc. · 1993
- 2 generations backK980746 Cedia Dau Eddp AssayBoehringer Mannheim Corp. · 1998
- 1 generation backK081378 Dri Methadone Metabolite (100/300) Assay, Calibrators and ControlsThermo Fisher Scientific · 2009
- This deviceK092048 One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931780 | Methadone Metabolite Eia Assay | Diagnostic Reagents, Inc. | 1993 | — |
| −2 | K980746 | Cedia Dau Eddp Assay | Boehringer Mannheim Corp. | 1998 | — |
| −1 | K081378 | Dri Methadone Metabolite (100/300) Assay, Calibrators and Controls | Thermo Fisher Scientific | 2009 | — |
| 0 (this device) | 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 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K012595 | Acon MTD One Step Methadone Test Strip and Test Device | 2001 |
| * | K023617 | Dri Methadone Metabolite Enzyme ImmunoassaySummary page 2…test principle and technology of these rapid diagnostic tests enables substantial equivalence. Another predicate device, the DPI Methadone Metabolite Enzyme Assay (K0236 17), is a Liquid Homogeneous Enzyme Assay which detects EDDP with results being obtained spectrophotometrically. Although the test p… | 2003 |
| * | K081378 | Dri Methadone Metabolite (100/300) Assay, Calibrators and ControlsSummary page 3…the DRI Methadone Metabolite Enzyme Assay is also used in the substantial equivalence discussion. A predicate device with identical technology is K08 1378 -BionexiaTm Single and Multi- Strip Cassette/Dipstick DOA Screen Panels., which are rapid immunochromatographic imm… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K012595.
How does its category compare?
All DJR devicesDJR Enzyme Immunoassay, Methadone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 One Step EDDP (Methadone Metabolite) Test Strip is a rapid immunochromatographic immunoassay for the qualitative detection of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), an inactive metabolite of methadone, at a designated cutoff concentration of 300 nglmL. This product is used to obtain a visual, qualitative result and is intended for professional use and professionals at point of care sites. This assay provides only a preliminary…
Read the full statement (111 words)
The One Step EDDP (Methadone Metabolite) Test Strip is a rapid immunochromatographic immunoassay for the qualitative detection of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), an inactive metabolite of methadone, at a designated cutoff concentration of 300 nglmL. This product is used to obtain a visual, qualitative result and is intended for professional use and professionals at point of care sites.
This assay provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092048 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092048: One Step Eddp (Methadone Metabolite) Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092048
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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