510(k) · Cleared
Recalled · Class II · 2024Randox Lipoprotein
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 Sep 28, 2001 after a 130-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 2 times.
- Decided
- Sep 28, 2001
- Review
- 130 days
- Class
- Class II
- Product code
- JIS
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK011568 Randox LipoproteinRandox Laboratories, Ltd. · 2001
- Descendant · cites it directly · 0 of its ownK123046 Advia Chemistry Lipoprotein (a) Reagent Advia Chemistry Lipoprotein…Siemens Healthcare Diagnostics, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K123046Advia Chemistry Lipoprotein (a) Reagent Advia Chemistry Lipoprotein (a) CalibratorSiemens Healthcare Diagnostics, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011568 | Randox Lipoprotein | Randox Laboratories, Ltd. | 2001 | — |
| +1 | K123046 | Advia Chemistry Lipoprotein (a) Reagent Advia Chemistry Lipoprotein (a)… | Siemens Healthcare Diagnostics, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123046 | Advia Chemistry Lipoprotein (a) Reagent Advia Chemistry Lipoprotein (a) Calibrator | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2024 | Class II | Z-1017-2025 | No Marketing Application | Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. |
| Dec 20, 2024 | Class II | Z-1018-2025 | No Marketing Application | Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K123046 (Siemens Healthcare Diagnostics, Inc., 2012) 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 Ltd. Lipoprotein (a) test kit is an in vitro diagnostic réagent for the quantitative determination of Lipoprotein (a) in serum and plasma. The method is an immunoturbidimetric assay in which aggiutination occurs dué to an antigen-antibody reaction between Lp(a) in a sample and anti-Lp(a) antibody adsorbed to latex particles. The agglutination is detected as an absorbance change at 700nm proportional to the concentration of Lp(a)…
Read the full statement (128 words)
The Randox Laboratories Ltd. Lipoprotein (a) test kit is an in vitro diagnostic réagent for the quantitative determination of Lipoprotein (a) in serum and plasma.
The method is an immunoturbidimetric assay in which aggiutination occurs dué to an antigen-antibody reaction between Lp(a) in a sample and anti-Lp(a) antibody adsorbed to latex particles. The agglutination is detected as an absorbance change at 700nm proportional to the concentration of Lp(a) in the sample.
Lp(a) determination is intended for use in conjunction with ciinical evaluation, patient risk assessment and other lipid tests to evaluate disorders of lipid metabolism and lto assess coronary heart disease in specific populations.
This Application Sheet has been developed for the Hitachi 717 analyser and miust be used by suitably qualified laboratory personnel under appropriate laboratory conditions
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011568: Randox Lipoprotein.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011568
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026