# K052148: Total Iron-Binding Capacity Calibrator Set.  Direct Tibc Calibrator Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Reference Diagnostics, Inc.
- Decided: Nov 9, 2005 after 93 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The RDI Direct TIBC Calibrator Set is intended for medical purposes for use with the RDI Direct TIBC Kit to establish points of reference that are used in the quantitative determination of Total iron-Binding Capacity (TIBC) in human serum.

Source page: https://510kreport.com/device/K052148
Methodology: https://510kreport.com/methodology