# K041142: Randox Cannabinoids Asssay

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Nov 23, 2004 after 207 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- 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. The FDA summary names no predicate by number.

## Indications for use
The evidence®Cannabinoids test has been designed for use only on the evidence®analyser to detect cannabinoids in urine, using a cut-off of 50ng/ml. Qualitative results obtained can be utilised in the diagnosis of cannabinoid use or abuse. This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS. The Cannabinoids Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions. The evidence® Drugs of Abuse Calibrators. The evidence®Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone and 11-nor-D9-THC-9 carboxylic acid. There are 9 levels of calibrator- They have been developed for use in calibration of the evidence® system. The evidence®&Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K041142
Methodology: https://510kreport.com/methodology