# K113747: Randox Opiates Assay

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Aug 24, 2012 after 248 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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 Opiates Assay: The Randox Laboratories Ltd. Opiates Assay is an invitro diagnostic test for the qualitative and semi-quantitative analysis of Opiates in human urine. The cut off for both the qualitative and semi-quantitative application is 2000ng/mI for morphine to which the assay is calibrated. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Opiate use or overdose. The Randox Opiates 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 isfor purposes of (1) Enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GOMS, or (2) Permitting laboratories to establish quality control procedures. This assay provides only, a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatograph/Mass Spectrometry (GC/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. Randox Multidrug Calibrator Set: The Randox Multidrug Calibrator Set is for use on human urine samples. They are liquid calibrators containing Methamphetamine, Secobarbital, Methadone, and Morphine. There are 5 levels of calibrator. They have been developed for use in the calibration of Amphetamine, Barbiturates, Methadone and Opiate assays on the RX series analysers, which includes the RX Daytona and RX Imola. This in vitro diagnostic device is intended for prescription use only. Randox Multidrug Controls, Level 1 & 2: The Randox Multidrug Controls, level 1 and 2 are for use on human urine samples. They are liquid controls containing Methamphetamine, Secobarbital, Methadone, and Morphine. There are 2 levels of controls. They have been developed for use in the quality control of Am phetamine, Barbiturates, Methadone and Opiate assays on the RX series analysers, which includes the RX Daytona and FiX Imola. This in vitro diagnostic device is intended for prescription use only.

Source page: https://510kreport.com/device/K113747
Methodology: https://510kreport.com/methodology