# K061251: Dimension Vista Total Iron Binding Capacity Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: May 31, 2006 after 27 days
- Product code: JIS (Calibrator, Primary)
- 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 K863840 (1986). 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)
- K994114: Dimension Total Iron Binding Capacity (Ibct) Calibrator, Dade Behring, Inc. (2000) Summary page 1.

## Indications for use
The Dimension VistaT M Total Iron Binding Capacity (TIBC) Calibrator is intended for use in the calibration of the TIBC method on the Dimension VistaT M system.

Source page: https://510kreport.com/device/K061251
Methodology: https://510kreport.com/methodology