# K041793: Olympus Unsaturated Iron Binding Capcity Reagent, OSR6124/0SR6524

- Pathway: 510(k) (Special)
- Applicant: Olympus America, Inc.
- Decided: Jul 16, 2004 after 14 days
- Product code: JMO (Ferrozine (Colorimetric) Iron Binding Capacity)
- Device class: 1
- Regulation: 21 CFR 862.1415
- Recalls of this device: 2 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jun 26, 2025 · Class II · Z-2264-2025: Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up t
- Aug 18, 2020 · Class II · Z-3028-2020: The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range.

## Indications for use
An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum and plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Source page: https://510kreport.com/device/K041793
Methodology: https://510kreport.com/methodology