510(k) · Cleared
ClearedADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · JIT Calibrator, Secondary
Cleared on Nov 17, 2016 as substantially equivalent to K142864 (Siemens Healthcare Diagnostics, Inc., 2014) and 1 other predicate after a 66-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Nov 17, 2016
- Review
- 66 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K001015 (2000). 11 ancestors in all, the oldest K903628 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK001015 Elecsys Thyroglobulin CalcheckRoche Diagnostics Corp. · 2000
- 5 generations backK020883 Elecsys Probnp CalcheckRoche Diagnostics Corp. · 2002
- 4 generations backK031698 Elecys SHBG CalcheckRoche Diagnostics Corp. · 2003
- 3 generations backK040157 Elecsys C-Peptide CalcheckRoche Diagnostics Corp. · 2004
- 2 generations backK100810 Elecsys C-Peptide Calcheck 5Roche Diagnostics · 2010
- 1 generation backK142864 ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA…Siemens Healthcare Diagnostics, Inc. · 2014
- This deviceK162538 ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA…Siemens Healthcare Diagnostics · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001015 | Elecsys Thyroglobulin Calcheck | Roche Diagnostics Corp. | 2000 | — |
| −5 | K020883 | Elecsys Probnp Calcheck | Roche Diagnostics Corp. | 2002 | — |
| −4 | K031698 | Elecys SHBG Calcheck | Roche Diagnostics Corp. | 2003 | — |
| −3 | K040157 | Elecsys C-Peptide Calcheck | Roche Diagnostics Corp. | 2004 | — |
| −2 | K100810 | Elecsys C-Peptide Calcheck 5 | Roche Diagnostics | 2010 | — |
| −1 | K142864 | ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 JIT? 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 |
|---|---|---|---|
| * | K142864 | ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI)…Summary page 4…IA Centaur® Insulin (IRI) ADVIA Centaur® Insulin (IRI) Master Curve Material (MCM) Calibrator 510(k) No. K142864 K021535 Page 4 - 1 Device Description:… | 2014 |
| * | K021535 | Advia Cantaur and Acs:180 Insulin CalibratorSummary page 4…IA Centaur® Insulin (IRI) Master Curve Material (MCM) Calibrator 510(k) No. K142864 K021535 Page 4 - 1 Device Description: ADVIA Centaur® Insulin (IR… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The ADVIA Centaur® Insulin (IRI) Master Curve Material (MCM) is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur® Insuin assay.
The ADVIA Centaur® Insulin (IRI) Calibrator is for in vitro diagnostic use in calibrating the ADVIA Centaur® systems Insulin assays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162538: ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162538
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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