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AESKULISA dsDNA-G is a solid phase enzyme immunoassay with human recombinant doublestranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum.

The assay is a tool in the diagnosis of systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.

AESKULISA dsDNA-G is a solid phase enzyme immunoassay with human recombinant doublestranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum.

The provided text is a 510(k) clearance letter from the FDA for a diagnostic device, AESKULISA dsDNA G. It does not contain information about specific acceptance criteria for performance, details of a study proving the device meets those criteria, sample sizes, expert qualifications, or ground truth methodologies that would typically be found in a study report.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device and outlines the regulatory framework. It specifies the product's intended use as a tool for diagnosing systemic lupus erythematosus (SLE) by detecting IgG antibodies against dsDNA.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of the other questions based on the provided text. The requested information about acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this regulatory document.

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