510(k) · Cleared
ClearedRandox Methamphetamine Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · DKB Calibrators, Drug Mixture
Cleared on May 9, 2011 after a 650-day review. The FDA summary names no predicate by number.
- Decided
- May 9, 2011
- Review
- 650 days
- Class
- Class II
- Product code
- DKB
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
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 DKB devicesDKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DKB
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DKB
Too few DKB 510(k)s in any year since 2007 to give a median.
Recalls per year · DKB
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKB
1in 2017
MAUDE reports naming product code DKB, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 2 | 1 |
| 2012 | 1 | — | 1 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (305 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092266 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092266: Randox Methamphetamine Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092266
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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