510(k) · Cleared
Recalled · Class II · 2022Randox Assayed Specific Protein 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 Aug 4, 1997 after a 54-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 6 times.
- Decided
- Aug 4, 1997
- Review
- 54 days
- Class
- Class I
- Product code
- JJY
- Recalls
- 6
- 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 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?
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 |
|---|---|---|---|---|
| Nov 22, 2022 | Class II | Z-0903-2023 | Under Investigation by firm | Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range |
| Nov 22, 2022 | Class II | Z-0904-2023 | Under Investigation by firm | Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range |
| Nov 22, 2022 | Class II | Z-0905-2023 | Under Investigation by firm | Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range |
| May 22, 2018 | Class II | Z-2279-2018 | Under Investigation by firm | The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used… |
| May 22, 2018 | Class II | Z-2278-2018 | Under Investigation by firm | The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used… |
| May 22, 2018 | Class II | Z-2280-2018 | Under Investigation by firm | The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I 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.
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 Limited Specific Protein Control Serum (Low and Elevated) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, particularly specific protein analysis. These control materials are available at two constituent concentrations.
The Randox Specific Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972608: Randox Assayed Specific Protein Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972608
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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