510(k) · Cleared
ClearedMethadone 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 4, 1997 after a 39-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Aug 4, 1997
- Review
- 39 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK972526 Methadone Eia AssayDiagnostic Reagents, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK023317 Methadone Enzyme ImmunoassayLin-Zhi International, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK192433 LZI Methadone II Enzyme ImmunoassayLin-Zhi International, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK033885 BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc. · 2004
Most influential descendants
Showing 3 of 3 · See all- K023317Methadone Enzyme ImmunoassayLin-Zhi International, Inc. · 2002 · cites it directly2descendants
- K192433LZI Methadone II Enzyme ImmunoassayLin-Zhi International, Inc. · 2019 · 2 generations on0descendants
- K033885BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972526 | Methadone Eia Assay | Diagnostic Reagents, Inc. | 1997 | — |
| +1 | K023317 | Methadone Enzyme Immunoassay | Lin-Zhi International, Inc. | 2002 | — |
| +2 | K192433 | LZI Methadone II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2019 | — |
| +2 | K033885 | BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit) | Lin-Zhi International, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2019 | 1 | 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 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023317 | Methadone Enzyme Immunoassay | 2002 | 2 |
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, K023317 (Lin-Zhi International, Inc., 2002) has gone furthest, with 2 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 | — |
What is it indicated for?
This homogeneous methadone enzyme immunoassay is intended to be used for qualitative and semi-quantitative determination of methadone in human urine.
The assay provides only a preliminary analytical result. A more specific alternate method must be used in order to obtain a confirmed analytical result. Gas chromatograph/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 used.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972526: Methadone 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/K972526
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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