# K092266: Randox Methamphetamine Assay

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: May 9, 2011 after 650 days
- Product code: DKB (Calibrators, Drug Mixture)
- Device class: 2
- Regulation: 21 CFR 862.3200
- 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 Methamphetamine Assay The Randox Laboratories Ltd. Methamphetamine Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of Methamphetamine in human urine at the cut off of lOO0ng/ml. The assay is calibrated against methamphetamine. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Methamphetamine use or overdose. The Randox Methamphetamine Assay has been developed for use on the A- analysers, which includes the IP'dayto na" and the A~r This in vitro diagnostic device isintended 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 Muitidrug Calibrator Set The Randox Multidrug Calibrator Set consists of liquid calibrators containing Methamphetamine, Oxazepam and Methadone. There areS5 levels of calibrator. They have been developed for use in the calibration of Methamphetamine, Benzodiazepines and Methadone assays for use on the A- analysers, which includes ther~%daytonai"~ and the Aaoa. This in vitro diagnostic device isintended for prescription use only. Randox Multidrug Controls, Level 1 & 2 The Randox Multidrug Controls level 1 and 2 are liquid controls containing Methamphetamine, Oxazelpam and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Methamphetamine, Benzodiazepines and Methadone assays for use on the A'- analysers, which includes the AO'dayto na' and the *2.mar, This Invitro diagnostic device isintended for prescription use only.

Source page: https://510kreport.com/device/K092266
Methodology: https://510kreport.com/methodology