# K994114: Dimension Total Iron Binding Capacity (Ibct) Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 20, 2000 after 45 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: 1 generation back to K863840 (1986). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863840: Meth. & Cali. for the Dimension Clini/Chem. System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 1.

## Most influential descendants
- K061251: Dimension Vista Total Iron Binding Capacity Calibrator (2006), 0 descendants of its own
- K052867: Vitros Chemistry Products Dtibc Reagent (2005), 0 descendants of its own

## Indications for use
The IBCT Calibrator for the Dimension® Clinical Chemistry System is a device intended to calibrate the Dimension® clinical chemistry system for total iron binding capacity (IBCT) method.

Source page: https://510kreport.com/device/K994114
Methodology: https://510kreport.com/methodology