# K171168: VITROS Immunodiagnostic Products Insulin Calibrators

- Pathway: 510(k) (Abbreviated)
- Applicant: Ortho Clinical Diagnostics
- Decided: May 16, 2017 after 25 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: 3 generations back to K903628 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060359: Archiect Insulin and Controls, Model 8K41-01, 8K41-10, Denka Seiken Co., Ltd. (2006) Summary page 4.

## Indications for use
For in vitro diagnostic use only. For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of insulin in human serum and plasma (Li Heparin).

Source page: https://510kreport.com/device/K171168
Methodology: https://510kreport.com/methodology