510(k) · Cleared
ClearedMethadone Metabolite (Eddp) Enzime Immunoassay, Cat. NO. 190 (500 Test Kit), NO. 191 (5000 Test Kit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · DJR Enzyme Immunoassay, Methadone
Cleared on Oct 10, 2003 as substantially equivalent to K931780 (Diagnostic Reagents, Inc., 1993) after a 122-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Oct 10, 2003
- Review
- 122 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931780 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK931780 Methadone Metabolite Eia AssayDiagnostic Reagents, Inc. · 1993
- This deviceK031797 Methadone Metabolite (Eddp) Enzime Immunoassay, Cat. NO. 190 (500…Lin-Zhi International, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK170416 LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone…Lin-Zhi International, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…Lin-Zhi International, Inc. · 2017 · 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) | K031797 | Methadone Metabolite (Eddp) Enzime Immunoassay, Cat. NO. 190 (500 Test Kit)… | Lin-Zhi International, Inc. | 2003 | — |
| +1 | K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and… | Lin-Zhi International, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 3…Metabolite Enzyme Immunoassay is substantially equivalent to the Methadone Metabolite Enzyme Immunoassay (By DRVMicrogenics Corp.), cleared under premarket notification K93 1780. LZI’s Methadone Metabolite Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method princip… | 1993 |
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 |
|---|---|---|---|
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)… | 2017 | 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?
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 Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of Methadone Metabolite in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Methadone Metabolite Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical…
Read the full statement (104 words)
The Methadone Metabolite Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of Methadone Metabolite in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Methadone Metabolite Enzyme Immunoassay 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 (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgement 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 summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K031797 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031797: Methadone Metabolite (Eddp) Enzime Immunoassay, Cat. NO. 190 (500 Test Kit), NO. 191 (5000 Test Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031797
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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