510(k) · Cleared
ClearedCannabinoid Assay and the Randox Cannabinoid Calibrator/ Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Apr 8, 2011 after a 619-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 8, 2011
- Review
- 619 days
- Class
- Class II
- Product code
- LDJ
- 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 LDJ? 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 LDJ device
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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 LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LDJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDJ
48in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDJ
1in 2015
MAUDE reports naming product code LDJ, 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 | 2 | — | 4 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 219 | 0 | 0 |
| 2012 | 4 | 193 | 0 | 0 |
| 2013 | 3 | 162 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 48 | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Randox Cannabinolds Assay The Randox Laboratories Ltd. Cannabinold Assay is an in vitro diagnostic test for the detection of 11-nor-A 9-THC-9-COOH (THO) in human urine on the Rx imola and Rx Daytona. The cut off for 11-nor-A 9-THC-9-COOH (THO) is 50ng/mi, This in vitro diagnostic device is intended for prescription use only. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for…
Read the full statement (254 words)
Randox Cannabinolds Assay
The Randox Laboratories Ltd. Cannabinold Assay is an in vitro diagnostic test for the detection of 11-nor-A 9-THC-9-COOH (THO) in human urine on the Rx imola and Rx Daytona. The cut off for 11-nor-A 9-THC-9-COOH (THO) is 50ng/mi, This in vitro diagnostic device is intended for prescription use only.
The semi-quantitative 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) permitting 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 chramatographimass spectrometry (GCIMS) 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 Cannabinoid Calibrator Set
The Randox Cannabinoid Calibrator Set consists of liquid calibrators containing 11-nor-A 9-THC-9-COOH (THC). There are 5 levels of calibrator. They have been developed for use in the calibration of THC assays on the r(daytonW" and 0tn-a?' analysers. This in vitro diagnostic device is intended for prescription use only.
Randox Cannabinoid Controls, Level 1 & 2
The Randox Cannabinoid Controls, level 1 and 2 are liquid controls containing 11-nor-A 9-THC-9-COCH (THC). There are 2 levels of controls. They have been developed for use in the quality control of the THC assay on the tWdaytonaJ" and Amtanalysers. 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/K092269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092269: Cannabinoid Assay and the Randox Cannabinoid Calibrator/ Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092269
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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