510(k) · Cleared
ClearedRandox Speciality Control (I) Levels 1, 2 and 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 Jun 19, 2013 as substantially equivalent to K043108 (Bio-Rad Laboratories, Inc., 2004) after a 128-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Jun 19, 2013
- Review
- 128 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K891475 (1989). No later device cites it as a predicate yet.
- Root · 3 generations backK891475 Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3Bio-Rad · 1989
- 2 generations backK981532 Lyphochek Immunoassay Plus ControlBio-Rad · 1998
- 1 generation backK043108 Liquichek Specialty Immunoassay ControlBio-Rad Laboratories, Inc. · 2004
- This deviceK130337 Randox Speciality Control (I) Levels 1, 2 and 3Randox Laboratories Limited · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K891475 | Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3 | Bio-Rad | 1989 | — |
| −2 | K981532 | Lyphochek Immunoassay Plus Control | Bio-Rad | 1998 | — |
| −1 | K043108 | Liquichek Specialty Immunoassay Control | Bio-Rad Laboratories, Inc. | 2004 | — |
| 0 (this device) | K130337 | Randox Speciality Control (I) Levels 1, 2 and 3 | Randox Laboratories Limited | 2013 | — |
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 |
|---|---|---|---|
| * | K043108 | Liquichek Specialty Immunoassay ControlSummary page 3…RY NAMES AND 510 (k) NUMBERS Predicate Device Pro 'rietary Name:' 4 . ' BIO-RAD Liquichek™ Speciality Immunoassay Control Levels LTA Levels 1, 2 and 3. 510 (k) Number: K043108 5. INTENDED USE The Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 are intended for in vitro diagnostic use as ass… | 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)
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 24 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K043108.
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. 2013, 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 Immunoassay Speciality Control (I) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for 1-25 Dihydroxy Vitamin D (1-25 (OH)2 Vitamin D), 25 Hydroxy Vitamin D (25 OH Vitamin D), Anti-Thyroglobulin (Anti TG), Anti-Thyroid Peroxidase (Anti TPO), C-Peptide, Insulin Like Growth Factor (IGF 1), Parathyroid Hormone (PTH), Procalcitonin and Insulin.
This device is for prescription use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130337 · printed Nov 3, 2026
Cite this page
510(k) Report. “K130337: Randox Speciality Control (I) Levels 1, 2 and 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K130337
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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