# K030360: Randox Evidence

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Dec 23, 2003 after 323 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K030360
Methodology: https://510kreport.com/methodology