K-ASSAY C3

• K Number: K993437
• Device Name: K-ASSAY C3
• Manufacturer: KAMIYA BIOMEDICAL CO.
• Date Cleared: 1999-11-24 ( 43 days)
• Product Code: CZW
• Regulation Number: 866.5240
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: N/A

Intended Use

The K-ASSAY Complement C3 Assay is intended to be used for the quantitative determination of Complement C3 in human serum by immunoturbidimetric assay. Complement is a group of serum proteins which destroy infectious agents. Measurement of these proteins aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. FOR IN VITRO DIAGNOSTIC USE.

Device Description

Not Found

AI/ML Overview

I am sorry. This document is a letter from the FDA regarding the K-ASSAY C3 device and an "Indications for Use Statement". It does not contain information about acceptance criteria, study details, or device performance metrics. Therefore, I cannot provide the requested table and study information based on the provided text.

Regulation Number and Section

§ 866.5240 Complement components immunological test system.

(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).