# K061885: Dimension Vista System Total Triiodothyronine Calibrator, Model KC250

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 14, 2006 after 42 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 K953160 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032697: Dimension Total Triiodothyronine Calibrator (RC414), Dade Behring, Inc. (2003) Summary page 1.

## Indications for use
The T3 CAL is an in vitro diagnostic product for the calibration of Total Triiodothyronine (T3) method on the Dimension Vista System.

Source page: https://510kreport.com/device/K061885
Methodology: https://510kreport.com/methodology