# K113751: Randox Cocaine Metabolite

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: May 8, 2012 after 139 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K150925: Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set (2015), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K113751
Methodology: https://510kreport.com/methodology