# K960485: Synchron Systems Iron (FE)/Total Iron Binding Capacity Reagents

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: May 10, 1996 after 98 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 K870986 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870986: Liquid-Stat Iron Reagent Kit & Tibc Reagent Kit, Beckman Instruments, Inc. (1987) Summary page 1.
- K893662: J&S Iron Saturating Reagents, J.S. Medical Assoc. (1989) Summary page 1.

## Indications for use
The SYNCHRON Systems Iron (FE) and Iron Binding Capacity (IBCT) Reagents, in conjunction with SYNCHRON Systems iron/TIBC Calibrator, are intended for use in the quantitative determination of iron and total iron binding capacity in human serum and plasma samples. These assays are designed for use with the family of SYNCHRON Systems such as the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.

Source page: https://510kreport.com/device/K960485
Methodology: https://510kreport.com/methodology