Transferrin

• K Number: K190495
• Device Name: Transferrin
• Manufacturer: BioSystems S.A.
• Date Cleared: 2020-03-16 ( 382 days)
• Product Code: DDG
• Regulation Number: 866.5880
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a standard FDA clearance letter and does not contain information about the acceptance criteria, study details, or performance of the "Transferrin" device mentioned. The letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not include the technical or clinical study data.

To answer your request, I would need a document that describes the actual performance study and its results.

Regulation Number and Section

§ 866.5880 Transferrin immunological test system.

(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).