QACA IGG/IGM ELISA KIT

• K Number: K020241
• Device Name: QACA IGG/IGM ELISA KIT
• Manufacturer: CHESHIRE DIAGNOSTICS LTD.
• Date Cleared: 2002-03-13 ( 49 days)
• Product Code: MID
• Regulation Number: 866.5660
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: N/A

Intended Use

The Cheshire Diagnostics Limited QACA IgG/IgM Elisa Kit is an enzyme linked immunoassay for the in vitro semi-quantitative detection of IgG and IgM antibodies to cardiolipin in human serum.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the QACA IgG/IgM ELISA Kit, indicating substantial equivalence to a predicate device. It does not contain a detailed study report with acceptance criteria and performance data. Therefore, I cannot extract the requested information. The letter only confirms the device can be legally marketed based on its equivalence.

Regulation Number and Section

§ 866.5660 Multiple autoantibodies immunological test system.

(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).