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This assay is designed for the in-vitro measurement of Specific ige antibodies pssocies of celiac disease.

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I am sorry, but the provided text from the FDA 510(k) notification for the "Bindazyme Antigliadin IgG" device does not contain the detailed study information required to fill out the requested table and answer the specific questions about acceptance criteria, study design, and performance.

The document is a notification from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and can proceed to market. It outlines regulatory requirements but does not include the actual study data, acceptance criteria, or performance metrics from the manufacturer's submission.

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

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This assay is designed for the in-vitro measurement of specific IgA antibodies present in human serum against gliadin, as an aid in the diagnosis of celiac disease. When sold in combination these assays are designed for in human measurement of specific IgG and IgA antibodies present in human serum against gliadin, as an aid in the diagnosis of celiac disease.

Diagnostic Test Kits

This looks like a 510(k) clearance letter for an in-vitro diagnostic device, specifically the "Bindazyme Antigliadin IgG/IgA Combined Kit". As an in-vitro diagnostic device, the acceptance criteria and study information typically found in submissions for medical imaging AI/ML devices or other software as a medical device (SaMD) are not present in this type of document.

The provided text consists of the FDA clearance letter, which confirms the device's substantial equivalence to a predicate device. It does not contain details about performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement as requested for a standalone AI/ML device.

Therefore, I cannot provide the requested information from the provided text.

No information regarding acceptance criteria or performance studies for the Bindazyme Antigliadin IgG/IgA Combined Kit is available in the provided document.

This document is a 510(k) clearance letter, which primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study reports.

Ask a specific question about this device