# K982041: UIBC

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jul 30, 1998 after 50 days
- Product code: JMO (Ferrozine (Colorimetric) 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
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. The FDA summary names its predicate without a number.
- (no number) Boehringer Mannheim UIBC assay on the Hitachi 717 Analyzer: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K982041
Methodology: https://510kreport.com/methodology