510(k) · Cleared
ClearedArchiect Insulin and Controls, Model 8K41-01, 8K41-10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Denka Seiken Co., Ltd. · JIT Calibrator, Secondary
Cleared on Apr 14, 2006 as substantially equivalent to K021535 (Bayer Diagnostics Corp., 2002) and 1 other predicate after a 60-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Apr 14, 2006
- Review
- 60 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K903628 (1990). 4 ancestors in all, the oldest K901212 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK903628 Aia-Pack IriTosoh Corp. · 1990
- 1 generation backK021535 Advia Cantaur and Acs:180 Insulin CalibratorBayer Diagnostics Corp. · 2002 · Recalled
- This deviceK060359 Archiect Insulin and Controls, Model 8K41-01, 8K41-10Denka Seiken Co., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK171168 VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics · 2017
Most influential descendants
Showing 1 of 1 · See all- K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903628 | Aia-Pack Iri | Tosoh Corp. | 1990 | — |
| −1 | K021535 | Advia Cantaur and Acs:180 Insulin Calibrator | Bayer Diagnostics Corp. | 2002 | 2 |
| 0 (this device) | K060359 | Archiect Insulin and Controls, Model 8K41-01, 8K41-10 | Denka Seiken Co., Ltd. | 2006 | — |
| +1 | K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | Ortho Clinical Diagnostics | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K021535 | Advia Cantaur and Acs:180 Insulin CalibratorSummary page 3…Comparison of Technological Characteristics: The ARCHITECT® Insulin Calibrators (A-F) is substantially equivalent to the ADIVA Centaur® and ACS 180 Insulin Calibrators (K021535). Comparison with predicate: Calibrators Similarities: Calibrator Device Pred… | 2002 |
| * | K030452 | Bayer Ligand Plus 1, 2, 3 ControlsSummary page 4…1304 Comparison with predicate: Controls The ARCHITECT® Insulin Controls (Low, Medium and High) are substantially equivalent to the Bayer Ligand Plus 1, 2, 3 Controls (K030452). Comparison with predicate: Controls Similarities: Controls Device Predica… | 2003 |
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 |
|---|---|---|---|
| K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | 2017 | 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 16 years and passes through 3 companies; a new generation was cleared every 11.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K171168 (Ortho Clinical Diagnostics, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K021535.
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 ARCHITECT® Insulin Calibrators are for the calibration of the ARCHTECT® i System when used for the quantitative determination of human insulin in human serum and plasma.
The ARCHITECT® Insulin Controls are for the verification of the accuracy and precision of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum or plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060359: Archiect Insulin and Controls, Model 8K41-01, 8K41-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060359
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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