# K051111: Sentinel Uibc Liquid

- Pathway: 510(k) (Traditional)
- Applicant: Sentinel Ch. Srl
- Decided: Nov 17, 2005 after 199 days
- Product code: JQF (Bathophenanthroline, Iron Binding Capacity)
- Device class: 1
- Regulation: 21 CFR 862.1415
- 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 K770748 (1977). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K770748: Test, Ferrozine Iron & Iron Binding, Hycel, Inc. (1977) Summary page 2.

## Indications for use
The Sentinel UIBC Liquid (Unsaturated Iron Binding Capacity) assay is intended to measure the unsaturated iron-binding capacity in serum and plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. CFR 862.1415

Source page: https://510kreport.com/device/K051111
Methodology: https://510kreport.com/methodology