510(k) · Cleared
ClearedRandox C-Reactive Protein Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · JIS Calibrator, Primary
Cleared on Nov 5, 2002 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Nov 5, 2002
- Review
- 85 days
- Class
- Class II
- Product code
- JIS
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK022682 Randox C-Reactive Protein CalibratorRandox Laboratories, Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK081294 Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein…Siemens Healthcare Diagnostics, Inc. · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK072658 Advia Chemistry C-Reactive Protein_2, (CRP_2) and CalibratorsSiemens Medical Solutions Diagnostics · 2008
Most influential descendants
Showing 2 of 2 · See all- K081294Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein (Hscrp), CalibratorsSiemens Healthcare Diagnostics, Inc. · 2008 · cites it directly0descendants
- K072658Advia Chemistry C-Reactive Protein_2, (CRP_2) and CalibratorsSiemens Medical Solutions Diagnostics · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022682 | Randox C-Reactive Protein Calibrator | Randox Laboratories, Ltd. | 2002 | — |
| +1 | K081294 | Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein (Hscrp)… | Siemens Healthcare Diagnostics, Inc. | 2008 | 2 |
| +1 | K072658 | Advia Chemistry C-Reactive Protein_2, (CRP_2) and Calibrators | Siemens Medical Solutions Diagnostics | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 JIS? 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K081294 (Siemens Healthcare Diagnostics, Inc., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JIS devicesJIS Calibrator, Primary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIS
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JIS
Too few JIS 510(k)s in any year since 2007 to give a median.
Recalls per year · JIS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIS
1in 2024
MAUDE reports naming product code JIS, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 5 |
| 2012 | 1 | — | 1 | 5 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 7 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Randox Laboratories Limited C-Reactive Protein Calibrators are liquid calibrators containing human recombinant CRP in a stabilised protein matrix. They have been developed for use in the calibration of CRP assays. The constituent concentrations of the Randox Laboratories Limited C-Reactive Protein Calibrator are present at 6 levels.
The Randox Laboratories Limited C-Reactive 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/K022682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022682: Randox C-Reactive Protein Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022682
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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