510(k) · Cleared
ClearedRandox Cocaine Metabolite
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 May 8, 2012 after a 139-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- May 8, 2012
- Review
- 139 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK113751 Randox Cocaine MetaboliteRandox Laboratories, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK150925 Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2015
Most influential descendants
Showing 1 of 1 · See all- K150925Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine…Immunalysis Corporation · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K113751 | Randox Cocaine Metabolite | Randox Laboratories, Ltd. | 2012 | — |
| +1 | K150925 | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis… | Immunalysis Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
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 3.0 · 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150925 | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine… | 2015 | 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?
- Of its descendants, K150925 (Immunalysis Corporation, 2015) has gone furthest, with 0 descendants of its own.
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. 2012, this device’s year, is highlighted.
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?
Randox Laboratories Ltd. Cocaine Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of Cocaine in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for Benzoylecgonine. Qualitative and semi-quantitative results can be utilized in the diagnosis arid treatment of Cocaine use or overdose. The Randox Cocaine Metabolite Assay has been developed for use on the RX series…
Read the full statement (312 words)
Randox Laboratories Ltd. Cocaine Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of Cocaine in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for Benzoylecgonine. Qualitative and semi-quantitative results can be utilized in the diagnosis arid treatment of Cocaine use or overdose. The Randox Cocaine 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 in appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS
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 chromatograph/mass spectrometry (CiC/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.
The Randox Multidirug Calibrator Set -consists of liquid calibrators containing Methamphetamine, Secobarbital, Oxazepamn, Benzoylecgonine and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Amphetamine, Barbiturates, Cocaine and Methadone assays on the RX series analysers, which includes the RN Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.
The Randox Multidrug Controls, level I and 2 are liquid controls containing Methamphetamnine, Secobarbital, Oxazepamn, Benzoy'lecgonine and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Amphetamine, Barbiturates, Cocaine and Methadone 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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K113751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113751: Randox Cocaine Metabolite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113751
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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