510(k) · Cleared
Recalled · Class II · 2024Randox 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 Jul 20, 2006 after a 94-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 20, 2006
- Review
- 94 days
- Class
- Class II
- Product code
- JIX
- Recalls
- 3
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK061056 Randox Liquid Protein CalibratorRandox Laboratories, Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK110736 Advia Chemistry Ferritin (FRT) MethodSiemens Healthcare Diagnostics, Inc. · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK103701 Advia Chemistry Liquid Specific Protein CalibratorsSiemens Healthcare Diagnostics, Inc. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061056 | Randox Liquid Protein Calibrator | Randox Laboratories, Ltd. | 2006 | — |
| +1 | K110736 | Advia Chemistry Ferritin (FRT) Method | Siemens Healthcare Diagnostics, Inc. | 2011 | 3 |
| +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 | 2 | 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? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2024 | Class II | Z-1328-2024 | Under Investigation by firm | The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC. |
| Jul 19, 2023 | Class II | Z-2448-2023 | Under Investigation by firm | As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots… |
| Aug 9, 2019 | Class II | Z-0283-2020 | Nonconforming Material/Component | The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K110736 (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 Calibrator (for neat sample assays) is derived from normal human serum obtained from volunteer donors. It has been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin, Transferrin and Haptoglobin assays (all neat sample assays). Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to International Reference Material CRM…
Read the full statement (181 words)
The Randox Laboratories Limited Liquid Protein Calibrator (for neat sample assays) is derived from normal human serum obtained from volunteer donors. It has been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin, Transferrin and Haptoglobin assays (all neat sample assays).
Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to International Reference Material CRM 470. The constituent concentrations of these Calibrators are present at levels 1, 2, 3, 4 and 5.
This calibrator can be used on Abbott Spectrum, Abbott aeroset, Abbott Architect i2000, Architect i2000sr, Ace Analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, Olympus AU800, AU600, AU400, AU2700, AU5400, Selectra vitalab, Synchron CX4 Synchron CX5 Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira plus systems
The Randox Laboratories Limited Liquid Protein Calibrators, should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
For in vitro diagnostic use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061056 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061056: 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/K061056
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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