510(k) · Cleared
ClearedRandox Apolipoprotein 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 Oct 24, 2002 after a 31-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Oct 24, 2002
- Review
- 31 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK023158 Randox Apolipoprotein CalibratorRandox Laboratories, Ltd. · 2002
- Descendant · cites it directly · 3 of its ownK041870 N Apolipoprotein Standard SerumDade Behring, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK063608 Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1…Dade Behring, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK181373 Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018
- Descendant · 2 generations on · 0 of its ownK042521 Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits…Ortho-Clinical Diagnostics, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K041870N Apolipoprotein Standard SerumDade Behring, Inc. · 2004 · cites it directly3descendants
- K063608Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and…Dade Behring, Inc. · 2007 · 2 generations on1descendant
- K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018 · 3 generations on0descendants
- K042521Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22 and APOA1…Ortho-Clinical Diagnostics, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023158 | Randox Apolipoprotein Calibrator | Randox Laboratories, Ltd. | 2002 | — |
| +1 | K041870 | N Apolipoprotein Standard Serum | Dade Behring, Inc. | 2004 | — |
| +2 | K063608 | Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1… | Dade Behring, Inc. | 2007 | — |
| +3 | K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | 2018 | — |
| +2 | K042521 | Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2018 | 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? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041870 | N Apolipoprotein Standard Serum | 2004 | 3 |
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, K041870 (Dade Behring, Inc., 2004) has gone furthest, with 3 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 Apolipoprotein Calibrator is based on lyophilised human
serum and has been developed for use in the calibration of Apolipoprotein A-I and
Apolipoprotein B assays. The constituent concentrations of the Randox Laboratories Limited
Apolipoprotein Calibrator are present at 1 level.
The Randox Labotatories Limited Apolipoprotein Calibrator should only be used by suitably
qualified personnel, under appropriate laboratory conditions.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023158: Randox Apolipoprotein Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023158
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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