# K092275: Randox Ecstasy (Mdma) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Mar 1, 2011 after 581 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- 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 Ecstasy Assay The Randox Laboratories Ltd. Ecstasy Assay is an in vitro diagnostic test for the detection of MOMA in human urine with a cut off concentration of SO0ng/mi, for use on the &idaytonad" and Ahmca" analysers in qualitative or semi-quantitative mode. The assay is calibrated against MOMA. This in vitro diagnostic device is intended for prescription use only. The semi-quantitalive 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) permittinig 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 chromatograph/mass spectrometry (OCIMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, p~articularly when the preliminary result is positive. Randox Ecstasy Calibrator Set The Randox Ecstasy Calibrator Set consists of liquid calibrators containing MDMD. There are 5 levels of calibrator. They have been developed for use in the calibration of Ecstasy assays on the 1Xdatntm and Ainawor analysers. This in vitro diagnostic device is intended for prescription use only. Randox Ecstasy Controls, Level I & 2 The Randox Ecstasy Controls, level 1 and 2 are liquid controls containing MOMA. There are 2 levels of controis. They have been developed for use in the quality control of the Ecstasy assay on the FXcdavtona" and Ain oanaysers. This in vitro diagnostic device is intended for prescription use only.

Source page: https://510kreport.com/device/K092275
Methodology: https://510kreport.com/methodology