# K060359: Archiect Insulin and Controls, Model 8K41-01, 8K41-10

- Pathway: 510(k) (Abbreviated)
- Applicant: Denka Seiken Co., Ltd.
- Decided: Apr 14, 2006 after 60 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K903628 (1990). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021535: Advia Cantaur and Acs:180 Insulin Calibrator, Bayer Diagnostics Corp. (2002) Summary page 3.
- K030452: Bayer Ligand Plus 1, 2, 3 Controls, Bayer Diagnostics Corp. (2003) Summary page 4.

## Most influential descendants
- K171168: VITROS Immunodiagnostic Products Insulin Calibrators (2017), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K060359
Methodology: https://510kreport.com/methodology