C3 MININEPH ANTISERUM

• K Number: K981783
• Device Name: C3 MININEPH ANTISERUM
• Manufacturer: THE BINDING SITE, LTD.
• Date Cleared: 1999-12-20 ( 579 days)
• Product Code: CZW
• Regulation Number: 866.5240
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

This assay is designed for the in vitro measurement of human C3 on an accepted analyzer as an aid in the diagnosis of abnormal C3 metabolism.

Device Description

Not Found

AI/ML Overview

This is an FDA Premarket Notification (510(k)) K981783 for C3 Minineph Antiserum. The document is a clearance letter and does not contain details about acceptance criteria or specific study designs to prove device performance. The letter states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from 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).