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This assay is designed for the in-vitro measurement of specific IgG autoantibodies aqainst tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of Coeliac disease.
This assay is designed for the in-vitro measurement of specific IqA autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of Coeliac disease.

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This document is a 510(k) premarket notification for two in-vitro diagnostic devices: "Bindazyme® Human IgG Anti-Tissue Transglutaminase Enzyme Immunoassay Kit" and "Bindazyme® Human IgA Anti-Tissue Transglutaminase Enzyme Immunoassay Kit". As such, it's a notification seeking regulatory clearance based on substantial equivalence to a predicate device, rather than a detailed study report proving performance against explicit acceptance criteria in the manner of a clinical trial for a novel device. The document does not contain the specific information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert-related details typically found in a clinical study report.

Therefore, I cannot provide the requested information from the provided text. The document primarily focuses on the FDA's decision regarding substantial equivalence for marketing purposes.

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