510(k) · Cleared
ClearedElecsys C-Peptide Calset
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Feb 13, 2004 as substantially equivalent to K031299 (Roche Diagnostics Corp., 2003) after a 60-day review. Its family tree reaches back 3 generations to 1990. 12 later devices descend from it.
- Decided
- Feb 13, 2004
- Review
- 60 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K900779 (1990). 12 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK900779 Enzymun Test (R) LHBoehringer Mannheim Corp. · 1990
- 2 generations backK964694 Elecsys LH AssayBoehringer Mannheim Corp. · 1997
- 1 generation backK031299 Elecsys LH Calset IIRoche Diagnostics Corp. · 2003
- This deviceK033873 Elecsys C-Peptide CalsetRoche Diagnostics Corp. · 2004
- Descendant · cites it directly · 10 of its ownK103221 Elecys HGH Calset, Elecsys HGH Calcheck 5Roche Diagnostics · 2010
- Descendant · 2 generations on · 8 of its ownK113546 Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys…Roche Diagnostics · 2012
- Descendant · 3 generations on · 4 of its ownK162840 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl…Roche Diagnostics · 2017 · Recalled
- Descendant · 3 generations on · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
- Descendant · 4 generations on · 1 of its ownK210901 Elecsys Vitamin D total IIIRoche Diagnostics · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K103221Elecys HGH Calset, Elecsys HGH Calcheck 5Roche Diagnostics · 2010 · cites it directly10descendants
- K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics · 2012 · 2 generations on8descendants
- K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics · 2017 · 3 generations on4descendants
- K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · 3 generations on2descendants
- K210901Elecsys Vitamin D total IIIRoche Diagnostics · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900779 | Enzymun Test (R) LH | Boehringer Mannheim Corp. | 1990 | — |
| −2 | K964694 | Elecsys LH Assay | Boehringer Mannheim Corp. | 1997 | — |
| −1 | K031299 | Elecsys LH Calset II | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K033873 | Elecsys C-Peptide Calset | Roche Diagnostics Corp. | 2004 | — |
| +1 | K103221 | Elecys HGH Calset, Elecsys HGH Calcheck 5 | Roche Diagnostics | 2010 | — |
| +2 | K113546 | Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3… | Roche Diagnostics | 2012 | — |
| +3 | K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D… | Roche Diagnostics | 2017 | 2 |
| +3 | K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol… | Roche Diagnostics | 2013 | — |
| +4 | K210901 | Elecsys Vitamin D total III | Roche Diagnostics | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K031299 | Elecsys LH Calset IISummary page 1…ame: Calibrator, secondary Predicate The ElecsysO C-Peptide CalSet is substantially equivalent to the currently device marketed ElecsysS LH CalSet II (K03 1299). Device The Elecsys® C-Peptide CalSet is a lyophilized product consisting of Description synthetic human C-Pept… | 2003 |
What descends from it? (12)
See all 122 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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103221 (Roche Diagnostics, 2010) has gone furthest, with 10 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 Elecsys® C-Peptide CalSet is used for calibrating the quantitative C-Peptide assay on the Elecsys immunoassay systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033873 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033873: Elecsys C-Peptide Calset.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033873
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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