# K092269: Cannabinoid Assay and the Randox Cannabinoid Calibrator/ Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Apr 8, 2011 after 619 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Randox Cannabinolds Assay The Randox Laboratories Ltd. Cannabinold Assay is an in vitro diagnostic test for the detection of 11-nor-A 9-THC-9-COOH (THO) in human urine on the Rx imola and Rx Daytona. The cut off for 11-nor-A 9-THC-9-COOH (THO) is 50ng/mi, This in vitro diagnostic device is intended for prescription use only. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an 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 chramatographimass spectrometry (GCIMS) 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. Randox Cannabinoid Calibrator Set The Randox Cannabinoid Calibrator Set consists of liquid calibrators containing 11-nor-A 9-THC-9-COOH (THC). There are 5 levels of calibrator. They have been developed for use in the calibration of THC assays on the r(daytonW" and 0tn-a?' analysers. This in vitro diagnostic device is intended for prescription use only. Randox Cannabinoid Controls, Level 1 & 2 The Randox Cannabinoid Controls, level 1 and 2 are liquid controls containing 11-nor-A 9-THC-9-COCH (THC). There are 2 levels of controls. They have been developed for use in the quality control of the THC assay on the tWdaytonaJ" and Amtanalysers. This in vitro diagnostic device is intended for prescription use only.

Source page: https://510kreport.com/device/K092269
Methodology: https://510kreport.com/methodology