510(k) · Cleared
ClearedRandox Ecstasy (Mdma) Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Mar 1, 2011 after a 581-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 1, 2011
- Review
- 581 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (259 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K092275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092275: Randox Ecstasy (Mdma) Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092275
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026