510(k) · Cleared
ClearedRandox Evidence
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Dec 23, 2003 after a 323-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 23, 2003
- Review
- 323 days
- Class
- Class II
- Product code
- DIO
- 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 DIO? 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 DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.1 · 2 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 DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, 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 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Randox Laboratories Limited Cocaine Metabolite Assay is an in vitro diagnostic test for the qualitative determination of the major metabolite of cocaine, benzoylecgonine (BZG), in human urine. This is a competitive immunoassay. A cut-off of 300ng/ml benzoylecgonine has been established in line with SAMHSA recommendations. This assay is for use only on the automated Evidence TM Analyser. Note: This test provides only a preliminary analytical result. A…
Read the full statement (178 words)
The Randox Laboratories Limited Cocaine Metabolite Assay is an in vitro diagnostic test for the qualitative determination of the major metabolite of cocaine, benzoylecgonine (BZG), in human urine. This is a competitive immunoassay. A cut-off of 300ng/ml benzoylecgonine has been established in line with SAMHSA recommendations.
This assay is for use only on the automated Evidence TM Analyser.
Note: This test provides only a preliminary analytical result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrophotometry (GC/MS) is the preferred confirmatory method.
The Cocaine Metabolite Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The Randox Laboratories Limited Drugs of Abuse Calibrators are liquid calibrators containing benzoylecgonine. There are 9 levels of calibrator.
They have been developed for use in calibration of the Evidence' system.
These Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Evidence' is an automated immunoassay analyser with dedicated software. It is for use with the Randox Evidence Cocaine Assay.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030360 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030360: Randox Evidence.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030360
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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