510(k) · Cleared
ClearedRandox Benzodiazepine Class Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · JXM Enzyme Immunoassay, Benzodiazepine
Cleared on May 17, 2005 after a 111-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 17, 2005
- Review
- 111 days
- Class
- Class II
- Product code
- JXM
- 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 JXM? 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 JXM device
- #1 K243498 Alinity c Benzodiazepines Reagent Kitscore 8.8 · 2 generations · no Class I recall
- #2 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 JXM devicesJXM Enzyme Immunoassay, Benzodiazepine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JXM
Too few JXM 510(k)s in any year since 2007 to give a median.
Recalls per year · JXM
79in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXM
6in 2025
MAUDE reports naming product code JXM, 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 | 3 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 79 | 5 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
evidence® Benzodiazepine Assay The evidence® Benzodiazepine test has been designed for use on the evidence® analyser for qualitative detectioD of benzodiazepine compounds, drugs with sedative and hypnotic effects, in urine using a cut-off concentration of 200ng/ml. Qualitative results obtained can be utilized in the diagnosis and treatment of benzodiazepine use or overdose. evidence® performs two Benzodiazepine assays based on oxazepam (Benzodazepine…
Read the full statement (212 words)
evidence® Benzodiazepine Assay
The evidence® Benzodiazepine test has been designed for use on the evidence® analyser for qualitative detectioD of benzodiazepine compounds, drugs with sedative and hypnotic effects, in urine using a cut-off concentration of 200ng/ml. Qualitative results obtained can be utilized in the diagnosis and treatment of benzodiazepine use or overdose. evidence® performs two Benzodiazepine assays based on oxazepam (Benzodazepine AssaV 1) ardd - Ior'azeparn (Benzodiazepine Assay 2).
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 chromatography / mass spectrometry (GC/MS) is the preferred method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The evidence® benzodiazepine class assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The evidence® Drugs of Abuse Calibrators.
The evidence® Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone, morphine sulphate pentahydrate, Phenobarbital, 11-nor-D9-THC-9 carboxylic acid, oxazepam and lorazepam.
There are 9 levels of calibrator. They have been developed for use in calibration of the etidlnce® sytern.
The evidence® Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050179 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050179: Randox Benzodiazepine Class Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050179
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026