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

The AESKULISA Glia-G is a solid phase enzyme immunoassay for the semiquantitative and qualitative detection of IgG antibodies against Gliadin in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjuction with other serological tests and clinical findings.

solid phase enzyme immunoassay

The provided text appears to be an FDA 510(k) clearance letter for the AESKULISA® Glia A and AESKULISA® Glia G devices, which are solid phase enzyme immunoassays for detecting IgA and IgG antibodies against Gliadin.

Unfortunately, the provided document does not contain the acceptance criteria or the study details that prove the device meets these criteria.

FDA 510(k) clearance letters primarily focus on confirming the device's substantial equivalence to a legally marketed predicate device. They typically do not include the detailed performance data, acceptance criteria, or study methodologies that were submitted by the manufacturer to support their claims.

Therefore, I cannot provide the requested information based on the document provided. To answer your questions, I would need access to the actual 510(k) submission, specifically the sections detailing the analytical and clinical performance studies, including:

• Acceptance Criteria: What performance metrics (e.g., sensitivity, specificity, accuracy, precision) were targeted as acceptable for the device.
• Reported Device Performance: The results of the studies showing how the device actually performed against these criteria.
• Study Design: Details on sample size, data provenance, ground truth establishment, expert qualifications, and adjudication methods.
• MRMC or Standalone Studies: Information on the type of performance evaluation conducted.

Without this specific information from the actual submission, I cannot complete the table or answer the detailed questions about the study design.

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