510(k) · Cleared
ClearedRandox Ammonia Ethanol Control Levels 1, 2 and Level 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories Limited · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Mar 25, 2014 as substantially equivalent to K123198 (Bio-Rad Laboratories, 2012) after a 39-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Mar 25, 2014
- Review
- 39 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955024 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK955024 Liquichek Ethanol/Ammonia ControlBio-Rad · 1995
- 1 generation backK123198 Liquichek Ethanol/Ammonia Control Level 1 Model 271, Liquichek…Bio-Rad Laboratories · 2012
- This deviceK140393 Randox Ammonia Ethanol Control Levels 1, 2 and Level 3Randox Laboratories Limited · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955024 | Liquichek Ethanol/Ammonia Control | Bio-Rad | 1995 | — |
| −1 | K123198 | Liquichek Ethanol/Ammonia Control Level 1 Model 271, Liquichek Ethanol/Ammonia… | Bio-Rad Laboratories | 2012 | — |
| 0 (this device) | K140393 | Randox Ammonia Ethanol Control Levels 1, 2 and Level 3 | Randox Laboratories Limited | 2014 | — |
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 JJY? 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123198 | Liquichek Ethanol/Ammonia Control Level 1 Model 271, Liquichek Ethanol/Ammonia Control…Summary page 2…510 (k) Summary 4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS Predicate Device Proprietary Name: Liquichek Ethanol/ Ammonia Control 510 (k)Number: K1 231 98 5. INTENDED USE The Randox Ammonia Ethanol Control Levels 1,2 & 3 are intended for in vitro diagnostic use in the quality con… | 2012 |
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.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 17.0 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Randox Ammonia Ethanol Controls Levels 1,2, & 3 are intended for in vitro diagnostic use in the quality control of Ammonia and Alcohol Assays to monitor precision and to detect systematic analytical deviations on clinical chemistry systems. This device is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140393: Randox Ammonia Ethanol Control Levels 1, 2 and Level 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140393
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026