510(k) · Cleared
ClearedN Apolipoprotein Standard Serum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Jul 27, 2004 as substantially equivalent to K023158 (Randox Laboratories, Ltd., 2002) after an 18-day review. Its family tree reaches back 1 generation to 2002. 3 later devices descend from it.
- Decided
- Jul 27, 2004
- Review
- 18 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023158 (2002). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK023158 Randox Apolipoprotein CalibratorRandox Laboratories, Ltd. · 2002
- This deviceK041870 N Apolipoprotein Standard SerumDade Behring, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK063608 Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1…Dade Behring, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK181373 Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018
- Descendant · cites it directly · 0 of its ownK042521 Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits…Ortho-Clinical Diagnostics, Inc. · 2004
Most influential descendants
Showing 3 of 3 · See all- K063608Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and…Dade Behring, Inc. · 2007 · cites it directly1descendant
- K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018 · 2 generations on0descendants
- K042521Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22 and APOA1…Ortho-Clinical Diagnostics, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023158 | Randox Apolipoprotein Calibrator | Randox Laboratories, Ltd. | 2002 | — |
| 0 (this device) | K041870 | N Apolipoprotein Standard Serum | Dade Behring, Inc. | 2004 | — |
| +1 | K063608 | Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1… | Dade Behring, Inc. | 2007 | — |
| +2 | K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | 2018 | — |
| +1 | 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 | 1 | 0 |
| 2007 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023158 | Randox Apolipoprotein CalibratorSummary page 1…N Apolipoprotein Standard Serum / Calibrator, Class 11 (862.1150) 3. Identification of the Legally Marketed Device: Randox Apolipoprotein Calibrator (K023158) 4. Device Description: N Apolipoprotein Standard Serum is a lyophilized calibrator prepared from human s… | 2002 |
What descends from it? (3)
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?
- Its one ancestor has no recall.
- Of its descendants, K063608 (Dade Behring, Inc., 2007) has gone furthest, with 1 descendant 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?
For calibration of the Apolipoprotein A-I and Apolipoprotein B assays on BN™ Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041870 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041870: N Apolipoprotein Standard Serum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041870
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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