HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER

• K Number: K022083
• Device Name: HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
• Manufacturer: THE BINDING SITE, LTD.
• Date Cleared: 2002-07-16 ( 20 days)
• Product Code: CFN
• Regulation Number: 866.5510
• Type: Traditional
• Panel: Immunology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

This range of kits is intended for quantifying IgG Subclasses 1, 2, 3 & 4 immunoglobulins in serum on the Beckman Immage Analyzer.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document is an FDA 510(k) premarket notification letter for a device called "Human IgG Subclass Kit for Use on the Beckman Immage Analyser." It states that the device is substantially equivalent to a legally marketed predicate device.

The information primarily concerns regulatory approval, product codes, regulation numbers, and contact information for the FDA. It does not contain the technical details of a study or acceptance criteria as requested in your prompt.

Regulation Number and Section

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).