EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT

• K Number: K061408
• Device Name: EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT
• Manufacturer: EUROIMMUN US LLC
• Date Cleared: 2006-10-05 ( 136 days)
• Product Code: MVM
• Regulation Number: 866.5660
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: N/A

Intended Use

The EUROIMMUN Endomysium IFA kit is designed for the semi-quantitative and qualitative determination of antibodies against Endomysium (EMA) in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathies associated with celiac disease in conjunction with other laboratory and clinical findings.

Device Description

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AI/ML Overview

I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA clearance letter for a medical device (EUROIMMUN Endomysium IFA kit) and primarily discusses its regulatory classification and substantial equivalence to a predicate device. It does not include details about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications for performance evaluation.

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).