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AESKULISA tTg A is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of Ig A antibodies against tissue transglutaminase (tTG) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

AESKULISA tTg G is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of Ig G antibodies against tissue transglutaminase (tTG) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

AESKULISA tTg A is a solid phase enzyme immunoassay.
AESKULISA tTg G is a solid phase enzyme immunoassay.

This FDA Premarket Notification (510(k)) letter does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance as it focuses on the substantial equivalence determination for regulatory purposes.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for a specific study.
• Information on expert involvement, adjudication methods, or multi-reader multi-case studies.
• Results of standalone algorithm performance.

The provided document is a regulatory approval letter stating that the AESKULISA tTg A and G assays are substantially equivalent to legally marketed predicate devices, and outlines their intended use as aids in the diagnosis of celiac disease. It does not delve into the specifics of the performance studies that would have been submitted as part of the 510(k) application.

To get the information you are looking for, you would typically need to refer to the actual 510(k) submission document itself (which is usually a much larger technical file) or scientific publications related to the device's validation. This approval letter is merely the FDA's formal response to that submission.

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