# K070708: Olympus FT4-Free Thyroxine,  Olympus T4- Total Thyroxine, Model# OSR210102, OSR210104

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Life & Material Science Europa GmbH (Irish
- Decided: Aug 21, 2007 after 160 days
- Product code: CEC (Radioimmunoassay, Free Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1695
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Olympus fT4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human serum/plasma using the Olympus AU3000iTM Immunoassay System. Measurements obtained by this device are used in the diagnosis and treatment of thyroid disease. For in vitro diagnostic use only. The Olympus T4 assay is a paramagnetic particle, chemnilumninescent immunoassay for the quantitative, determination of total thyroxine levels in human serum/plasma using the Olympus AU3000iTM Immunoassay System. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K070708
Methodology: https://510kreport.com/methodology