# K981654: TIBC

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jul 22, 1998 after 72 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) A-GENT TIBC assay on the ABBOTT SPECTRUM Series II System: named in the summary without a submission number

## Indications for use
The Total Iron Binding Capacity (TIBC) assay uses TIBC sample pretreatment in conjunction with the Iron assay for the quantitation of the total iron binding capacity of human serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Source page: https://510kreport.com/device/K981654
Methodology: https://510kreport.com/methodology