Tosoh Corp.

Tosoh Corp. specializes in in vitro diagnostic (IVD) reagents and kits used primarily in clinical laboratories. Their portfolio includes liquid chromatography systems for measuring glycated haemoglobin (HbA1c), calibrators for estradiol (E2) and cancer antigen 125 (CA125), as well as controls, diluents, and enzyme immunoassay (EIA) kits for detecting biomarkers like CA125. These products support diagnostic testing for conditions such as diabetes, hormonal imbalances, and certain cancers.

Tosoh Corp. is based in the United States, which means its devices are subject to FDA regulations. The company’s products are classified under Class I (generally low-risk) and Class II (moderate-risk) categories, requiring compliance with FDA requirements such as the 510(k) premarket notification process and Unique Device Identifier (UDI) system to ensure traceability and safety in diagnostic testing.

Tosoh Corp.’s devices are listed in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency in the regulatory process, allowing healthcare providers and authorities to verify compliance with US requirements for in vitro diagnostics. The inclusion in these systems reflects the company’s adherence to FDA-mandated standards for device classification and market clearance.

Tosoh Corp.’s devices are classified under Class I (for lower-risk items like buffered solutions) and Class II (for higher-risk diagnostic tests like CA125 immunoassays and HbA1c systems). The classification depends on factors such as the device’s intended use, potential risks, and the level of regulatory oversight required. Class II devices typically require premarket notification (510(k)) to demonstrate substantial equivalence to existing approved products, while Class I devices may only need general controls unless exempt.