510(k) · Cleared
ClearedADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Oct 29, 2014 as substantially equivalent to K100810 (Roche Diagnostics, 2010) and 1 other predicate after a 28-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Oct 29, 2014
- Review
- 28 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001015 (2000). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK001015 Elecsys Thyroglobulin CalcheckRoche Diagnostics Corp. · 2000
- 4 generations backK020883 Elecsys Probnp CalcheckRoche Diagnostics Corp. · 2002
- 3 generations backK031698 Elecys SHBG CalcheckRoche Diagnostics Corp. · 2003
- 2 generations backK040157 Elecsys C-Peptide CalcheckRoche Diagnostics Corp. · 2004
- 1 generation backK100810 Elecsys C-Peptide Calcheck 5Roche Diagnostics · 2010
- This deviceK142864 ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK162538 ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA…Siemens Healthcare Diagnostics · 2016
Most influential descendants
Showing 1 of 1 · See all- K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorSiemens Healthcare Diagnostics · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001015 | Elecsys Thyroglobulin Calcheck | Roche Diagnostics Corp. | 2000 | — |
| −4 | K020883 | Elecsys Probnp Calcheck | Roche Diagnostics Corp. | 2002 | — |
| −3 | K031698 | Elecys SHBG Calcheck | Roche Diagnostics Corp. | 2003 | — |
| −2 | K040157 | Elecsys C-Peptide Calcheck | Roche Diagnostics Corp. | 2004 | — |
| −1 | K100810 | Elecsys C-Peptide Calcheck 5 | Roche Diagnostics | 2010 | — |
| 0 (this device) | K142864 | ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +1 | K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI)… | Siemens Healthcare Diagnostics | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 JJX? 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? (2)
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 |
|---|---|---|---|
| * | K100810 | Elecsys C-Peptide Calcheck 5Summary page 5…Unassayed) Panel: Clinical Chemistry (75) 3. Predicate Device Name Elecsys C-Peptide CalCheck 5 Predicate 510(k) No: K100810 4. Device Description: ADVIA Centaur® C-peptide Master Curve Material is an in vi… | 2010 |
| * | K101075 | Elecsys Insulin Calcheck 5Summary page 12…nel: Clinical Chemistry (75) 3. Predicate Device Name Elecsys Insulin CalCheck 5 Predicate 510(k) No: K101075 4. Device Description: ADVIA Centaur® Insulin Master Curve Materials is an in vitro… | 2010 |
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 |
|---|---|---|---|
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator | 2016 | 0 |
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 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K162538 (Siemens Healthcare Diagnostics, 2016) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K100810.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ADVIA Centaur® C-peptide (CpS) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur C-peptide assay.
The ADVIA Centaur® Insulin (IRI) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Insulin assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142864 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142864: ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142864
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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