510(k) · Cleared
ClearedRandox Methadone 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 18, 2010 after a 478-day review. The FDA summary names no predicate by number.
- Decided
- Nov 18, 2010
- Review
- 478 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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 Assay The Randox Laboratories Ltd. Methadone Assay Isan invitro diagnostic test for the qualitative and semi-quantitative detection of Methadone inhuman urine. The cut off far both the qua~ltative end semi-quantitative modes of the assay Is3O0ng/mi for methadone. The Randox Methadone Assay has been developed for use on theoiamsanalysers, which includes the .rrdavtona~m and theta*-ar. This in vitro diagnostic device isintended for…
Read the full statement (277 words)
Randox Methadone Assay
The Randox Laboratories Ltd. Methadone Assay Isan invitro diagnostic test for the qualitative and semi-quantitative detection of Methadone inhuman urine. The cut off far both the qua~ltative end semi-quantitative modes of the assay Is3O0ng/mi for methadone. The Randox Methadone Assay has been developed for use on theoiamsanalysers, which includes the .rrdavtona~m and theta*-ar. This in vitro diagnostic device isintended for prescription use only.
The semni-quantitative mode is for purposes of
(1) enabling laboratories to determine an appropriate dilution of the specimen for confirmal~on by a confirmatory method such as GOMS
or
(2) permitting laboratories to establish quality Control procedures,
This assay provides only a preliminary analytical result. Amore specific alternative chemical method must be used In order to obtain a confirmed analytical result. Gas chromatographtmass 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 Muludrug Calibrator Set
The Randox Multidrug Calibrator Set consists of liquid calibrators containing Oxazepam and Methadone, There are Slevels of Calibrator. They have been developed for use in the calibration of Benzodiazepine (Oxazepam) and Methadone assays on the fl- analysers. which includes the rWdaytornaT and the Afri... This In vitro diagnostic device isintended for prescription use only.
Randox Multidrug Controls, Level I & 2
The Randox Muitidrug Controls, level 1 and 2 are liquid controls containing Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use inthe quality control of Benzodiazepine and Methadone assays on thefls-. analysers, which includes the fldaytonaTm and the .Oftlsa&.r This invitro diagnostic device is intended for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092272: Randox Methadone Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092272
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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