# K092268: Randox Bariturates Assay

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: May 25, 2011 after 666 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- 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 Barbiturates Assay The Randox Laboratories Ltd. barbiturates Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on the Rx Imola and Rx Daytona. The cutoff for secobarbital is 200 ng/mL. This in vitro diagnostic device Is intended for prescription use only. The semi-quantitative mode is for purpose of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS. Or ... k2) 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 chromatographlmass 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 Multidrug Calibrator Set The Randox Multidrug Calibrator Set consists of liquid calibrators containing Secobarbital, Oxazepam and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Barbiturates, Benzodiazepines and Methadone assays for use on the fl-' analysers, which includes the JfldavtonaM and the JIMnotr. This in vitro diagnostic device is intended for prescription use only. Randox Niultidrug Controls, Level 1 & 2 The Randox Multidrug Controls level I and 2 are liquid controls containing Secobarbital, Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Barbiturates, Benrodiazepines and Methadone assays for use on the $r-nn analysers, which includes the ji(daytona'" and the Amr.This in vitro diagnostic device is intended for prescription use only.

Source page: https://510kreport.com/device/K092268
Methodology: https://510kreport.com/methodology