# K012340: Bayer Advia System; Unsaturated Iron Binding Capacity (Uibc)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Oct 1, 2001 after 69 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) Technicon CHEM 1: named in the summary without a submission number

## Indications for use
The ADVIA IMS Unsaturated lron Binding Capacity (UIBC) assay is an in vitro diagnostic device intended to measure iron binding capacity in human serum and plasma. Measurements of iron binding capacity are used in the diagnosis and treatment of anemias.

Source page: https://510kreport.com/device/K012340
Methodology: https://510kreport.com/methodology