510(k) · Cleared
Recalled · Class II · 2017Advia Cantaur and Acs:180 Insulin Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · JIT Calibrator, Secondary
Cleared on Jun 27, 2002 as substantially equivalent to K903628 (Tosoh Corp., 1990) after a 48-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 27, 2002
- Review
- 48 days
- Class
- Class II
- Product code
- JIT
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K903628 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK903628 Aia-Pack IriTosoh Corp. · 1990
- This deviceK021535 Advia Cantaur and Acs:180 Insulin CalibratorBayer Diagnostics Corp. · 2002
- Descendant · cites it directly · 1 of its ownK060359 Archiect Insulin and Controls, Model 8K41-01, 8K41-10Denka Seiken Co., Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK171168 VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics · 2017
- 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 3 of 3 · See all- K060359Archiect Insulin and Controls, Model 8K41-01, 8K41-10Denka Seiken Co., Ltd. · 2006 · cites it directly1descendant
- K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics · 2017 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −1 | K903628 | Aia-Pack Iri | Tosoh Corp. | 1990 | — |
| 0 (this device) | K021535 | Advia Cantaur and Acs:180 Insulin Calibrator | Bayer Diagnostics Corp. | 2002 | — |
| +1 | K060359 | Archiect Insulin and Controls, Model 8K41-01, 8K41-10 | Denka Seiken Co., Ltd. | 2006 | — |
| +2 | K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | Ortho Clinical Diagnostics | 2017 | — |
| +1 | K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI)… | Siemens Healthcare Diagnostics | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K903628 | Aia-Pack IriSummary page 1…Phone: +81-(3)-3275-122 1 Fax: +81-(3)-3275-1214 5 1O(k) Number: K903628 4. Device Description The ACS: 180 and ADVIA Centaur Insulin Calibrator is a casein buffered solution contain… | 1990 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 5, 2017 | Class II | Z-2086-2017 | Nonconforming Material/Component | Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other performance characteristics are being met… |
| Apr 5, 2017 | Class II | Z-2085-2017 | Nonconforming Material/Component | Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other performance characteristics are being met… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K060359 (Denka Seiken Co., Ltd., 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ACS: 180 and ADVIA Centaur Insulin calibrators are used for calibrating the ACS:180 and ADVIA Centaur Insulin Immunoassays.
The ACS:180 and ADVIA Centaur Insulin are sandwich, chemiluminescence immunoassay for the quantitative determination of Insulin in human serum for use on the automated analyzer marketed by Bayer Corporation. The ACS: 180 and ADVIA Centaur Insulin Immunoassays can be used to aid in the diagnosis and treatment of diabetes mellitus and hypoglycemia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021535: Advia Cantaur and Acs:180 Insulin Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021535
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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