510(k) · Cleared
Recalled · Class III · 2019Randox Immunoassay Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jun 16, 2004 after a 120-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 16, 2004
- Review
- 120 days
- Class
- Class I
- Product code
- JJY
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK040379 Randox Immunoassay ControlRandox Laboratories, Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK140522 Randox Immunoassay Premium Plus Control Levels 1,2 and Level 3 and…Randox Laboratories Limited · 2014 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K140522Randox Immunoassay Premium Plus Control Levels 1,2 and Level 3 and Immunoassay Premium…Randox Laboratories Limited · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040379 | Randox Immunoassay Control | Randox Laboratories, Ltd. | 2004 | — |
| +1 | K140522 | Randox Immunoassay Premium Plus Control Levels 1,2 and Level 3 and Immunoassay… | Randox Laboratories Limited | 2014 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140522 | Randox Immunoassay Premium Plus Control Levels 1,2 and Level 3 and Immunoassay Premium… | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2019 | Class III | Z-1105-2019 | Employee error | The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K140522 (Randox Laboratories Limited, 2014) has gone furthest, with 0 descendants of its own.
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.
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 Laboratories Ltd. Immunoassay Controls (Levels 1,11, and III) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, particularly Immunoassay analysis. The control materials are available at three constituent concentrations, Each level is available in a 5ml final re-constituted volume.
The Randox Assayed Immunoassay Controls should 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/K040379 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040379: Randox Immunoassay Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040379
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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