# K981279: TIBC

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 20, 1998 after 42 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
Longest line of descent: 1 generation back to K872494 (1987). 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)
- K872494: Hitachi 717 Chemistry Analyzer, Boehringer Mannheim Corp. (1987) Summary page 2.

## 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/K981279
Methodology: https://510kreport.com/methodology