NOVA LITE ENDOMYSIAL

• K Number: K980312
• Device Name: NOVA LITE ENDOMYSIAL
• Manufacturer: INOVA DIAGNOSTICS, INC.
• Date Cleared: 1998-04-02 ( 65 days)
• Product Code: DBL
• Regulation Number: 866.5660
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: N/A

Intended Use

An indirect immunofluorescent antibody test for the qualitative and semi-quantitative detection of IgA class endomysial autoantibodies (EMA) in human serum as an aid in the diagnosis of celiac disease and dermatitis herpetiformis.

Device Description

Not Found

AI/ML Overview

I'm sorry, but without further textual input, I cannot furnish information about acceptance criteria or supporting studies. The documents you provided appear to be an FDA 510(k) clearance letter and an "Indications For Use" statement for the "NOVA Lite™ Endomysial Antibody Test Kit," but they do not contain details regarding specific performance criteria or the studies conducted to demonstrate those criteria.

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).