510(k) · Cleared
ClearedRandox Metabolite (Eddp) Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · DJR Enzyme Immunoassay, Methadone
Cleared on Nov 9, 2010 after a 469-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 9, 2010
- Review
- 469 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
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.
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?
Randox Methadone Metabolite (EDOP) Assay The Randox Laboratories Ltd. Methadone Metabolite Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/mI for EDDP. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of EDDP use…
Read the full statement (314 words)
Randox Methadone Metabolite (EDOP) Assay
The Randox Laboratories Ltd. Methadone Metabolite Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/mI for EDDP. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of EDDP use or overdose. The Randox Methadone Metabolite Assay has been developed for use on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. This in vitro diagnostic device is intended for prescription use only.
The semi-quantitative mode is for purposes of
(1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GOMS
or
(2) permitting laboratories to establish quality control procedures.
This assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatographlmass spectrometry (GCIMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Randox EDDP Calibrator Set
The Randox EDDP Calibrator Set consists of liquid calibrators containing EDOP. There are 5 levels of calibrator. They have been developed for use in the calibration of EDDP assays on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. This in vitro diagnostic device is intended for prescription use only.
Randox EDOP Controls, Level 1 & 2
The Randox EDDP Controls, level 1 and 2 are liquid controls containing EDDP. There are 2 levels of controls. They have been developed for use in the quality control of the EDOP assay on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. This in vitro diagnostic device is intended for prescription use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K092258 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092258: Randox Metabolite (Eddp) Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092258
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026