510(k) · Cleared
ClearedRandox Opiates Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories Limited · DJG Enzyme Immunoassay, Opiates
Cleared on Aug 24, 2012 after a 248-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 24, 2012
- Review
- 248 days
- Class
- Class II
- Product code
- DJG
- 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 DJG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
Randox Opiates Assay: The Randox Laboratories Ltd. Opiates Assay is an invitro diagnostic test for the qualitative and semi-quantitative analysis of Opiates in human urine. The cut off for both the qualitative and semi-quantitative application is 2000ng/mI for morphine to which the assay is calibrated. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Opiate use or overdose. The Randox Opiates Assay has been…
Read the full statement (340 words)
Randox Opiates Assay: The Randox Laboratories Ltd. Opiates Assay is an invitro diagnostic test for the qualitative and semi-quantitative analysis of Opiates in human urine. The cut off for both the qualitative and semi-quantitative application is 2000ng/mI for morphine to which the assay is calibrated. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Opiate use or overdose. The Randox Opiates 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 isfor 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 test result. A more specific alternative chemical 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Randox Multidrug Calibrator Set: The Randox Multidrug Calibrator Set is for use on human urine samples. They are liquid calibrators containing Methamphetamine, Secobarbital, Methadone, and Morphine. There are 5 levels of calibrator. They have been developed for use in the calibration of Amphetamine, Barbiturates, Methadone and Opiate assays on the RX series analysers, which includes the RX Daytona and RX Imola. This in vitro diagnostic device is intended for prescription use only.
Randox Multidrug Controls, Level 1 & 2: The Randox Multidrug Controls, level 1 and 2 are for use on human urine samples. They are liquid controls containing Methamphetamine, Secobarbital, Methadone, and Morphine. There are 2 levels of controls. They have been developed for use in the quality control of Am phetamine, Barbiturates, Methadone and Opiate assays on the RX series analysers, which includes the RX Daytona and FiX 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/K113747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113747: Randox Opiates Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113747
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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