# K092272: Randox Methadone Assay

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Nov 18, 2010 after 478 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- 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
Randox Methadone Assay The Randox Laboratories Ltd. Methadone Assay Isan invitro diagnostic test for the qualitative and semi-quantitative detection of Methadone inhuman urine. The cut off far both the qua~ltative end semi-quantitative modes of the assay Is3O0ng/mi for methadone. The Randox Methadone Assay has been developed for use on theoiamsanalysers, which includes the .rrdavtona~m and theta*-ar. This in vitro diagnostic device isintended for prescription use only. The semni-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmal~on by a confirmatory method such as GOMS or (2) permitting laboratories to establish quality Control procedures, This assay provides only a preliminary analytical result. Amore specific alternative chemical method must be used In order to obtain a confirmed analytical result. Gas chromatographtmass 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 Muludrug Calibrator Set The Randox Multidrug Calibrator Set consists of liquid calibrators containing Oxazepam and Methadone, There are Slevels of Calibrator. They have been developed for use in the calibration of Benzodiazepine (Oxazepam) and Methadone assays on the fl- analysers. which includes the rWdaytornaT and the Afri... This In vitro diagnostic device isintended for prescription use only. Randox Multidrug Controls, Level I & 2 The Randox Muitidrug Controls, level 1 and 2 are liquid controls containing Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use inthe quality control of Benzodiazepine and Methadone assays on thefls-. analysers, which includes the fldaytonaTm and the .Oftlsa&.r This invitro diagnostic device is intended for prescription use only.

Source page: https://510kreport.com/device/K092272
Methodology: https://510kreport.com/methodology