510(k) · Cleared
Recalled · Class II · 2018Randox Liquid Protein Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Aug 8, 2003 after a 78-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
- Aug 8, 2003
- Review
- 78 days
- Class
- Class II
- Product code
- JIX
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK031608 Randox Liquid Protein CalibratorRandox Laboratories, Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK103701 Advia Chemistry Liquid Specific Protein CalibratorsSiemens Healthcare Diagnostics, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K103701Advia Chemistry Liquid Specific Protein CalibratorsSiemens Healthcare Diagnostics, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031608 | Randox Liquid Protein Calibrator | Randox Laboratories, Ltd. | 2003 | — |
| +1 | K103701 | Advia Chemistry Liquid Specific Protein Calibrators | Siemens Healthcare Diagnostics, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 JIX? 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 |
|---|---|---|---|
| K103701 | Advia Chemistry Liquid Specific Protein Calibrators | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 19, 2018 | Class II | Z-0660-2019 | Under Investigation by firm | Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K103701 (Siemens Healthcare Diagnostics, Inc., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Randox Laboratories Limited Liquid Protein Calibrators (for neat sample assays) are liquid calibrators derived from normal human serum obtained from volunteer donors. They have been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin and Transferrin assays (all neat sample assays). Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to material standardised…
Read the full statement (209 words)
The Randox Laboratories Limited Liquid Protein Calibrators (for neat sample assays) are liquid calibrators derived from normal human serum obtained from volunteer donors. They have been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin and Transferrin assays (all neat sample assays). Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations. The constituent concentrations of these Calibrators are present at levels 0, 1, 2, 3, 4 and 5. These calibrators also contain a-1-Antitrypsin (AAT) and Rheumatoid Factor (RF) for use in the calibration of AAT and RF assays on the Bayer Advia 1650 analyser only.
The Randox Laboratories Limited Liquid Protein Calibrators (for diluted sample assays) are liquid calibrators derived from normal human serum obtained from volunteer donors. They have been developed for the calibration of a-1-antitrypsin, a-1-acid glycoprotein, IgA, IgG, IgM and Transferrin assays which require sample pre-dilution. Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations. The constituent concentrations of these calibrators are present at levels 1, 2, 3, 4 and 5.
The Randox Laboratories Limited Liquid Protein Calibrators, 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/K031608 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031608: Randox Liquid Protein Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031608
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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