QUANTA LITE B2 GPI IGA

• K Number: K973006
• Device Name: QUANTA LITE B2 GPI IGA
• Manufacturer: INOVA DIAGNOSTICS, INC.
• Date Cleared: 1997-10-20 ( 68 days)
• Product Code: MSV
• Regulation Number: 866.5660
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: N/A
• Predicate For: K982434

Intended Use

semiquantitative enzyme linked immunoassay for detecting IgA A class autoantibody to f2 glycoprotein I (B2 GPI) for use as an aid diagnosis of certain autoimmune disease thrombotic in the disorders, such as those secondary to systemic lupus erythematosus (SLE) or other lupus-like disorders.

Device Description

Not Found

AI/ML Overview

This document is a marketing clearance letter from the FDA for the QUANTA Lite™ B2 GPI IgA ELISA device (K973006). It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It also mentions general regulatory requirements and where to get further information.

Therefore, I cannot provide the requested information based on the provided text.

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).