510(k) · Cleared
Recalled · Class III · 2023Randox Immunoassay Premium Plus Control Levels 1,2 and Level 3 and Immunoassay Premium Plus Tri-Level Control
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 May 22, 2014 as substantially equivalent to K040379 (Randox Laboratories, Ltd., 2004) after a 79-day review. Its family tree reaches back 1 generation to 2004. It has been recalled 5 times.
- Decided
- May 22, 2014
- Review
- 79 days
- Class
- Class I
- Product code
- JJY
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040379 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK040379 Randox Immunoassay ControlRandox Laboratories, Ltd. · 2004 · Recalled
- This deviceK140522 Randox Immunoassay Premium Plus Control Levels 1,2 and Level 3 and…Randox Laboratories Limited · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040379 | Randox Immunoassay Control | Randox Laboratories, Ltd. | 2004 | 1 |
| 0 (this device) | K140522 | Randox Immunoassay Premium Plus Control Levels 1,2 and Level 3 and Immunoassay… | 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 |
|---|---|---|---|
| * | K040379 | Randox Immunoassay ControlSummary page 2…4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS Predicate Device Proprietary Name: Randox Immunoassay Controls Levels 1, 2 and 3 510 (k)Numbers: K040379 5. INTENDED USE This product is intended for in vitro diagnostic use as assayed quality control material to monit… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 4, 2023 | Class III | Z-2022-2023 | Nonconforming Material/Component | Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has… |
| May 4, 2023 | Class III | Z-2021-2023 | Nonconforming Material/Component | Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has… |
| Feb 7, 2019 | Class III | Z-1106-2019 | 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. |
| Aug 11, 2017 | Class III | Z-0970-2018 | Device Design | The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU. |
| Aug 11, 2017 | Class III | Z-0969-2018 | Device Design | The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor 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?
This product is intended for in vitro diagnostic use as assayed quality control materials to monitor the accuracy and reproducibility of the analytes listed in the package insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140522 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140522: Randox Immunoassay Premium Plus Control Levels 1,2 and Level 3 and Immunoassay Premium Plus Tri-Level Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140522
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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