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This assay is intended for the in-vitro measurement of specific IgG, IgA and IgM autoantibodies against mitochondria present in human serum as an aid in the diagnosis of primary biliary cirrhosis (PBC) when used in conjunction with other clinical observations.

BINDAZYME® Anti-Mitochondria M2 IgGAM EIA Kit

The provided text describes a 510(k) premarket notification for the "BINDAZYME® Anti-Mitochondria M2 IgGAM EIA Kit." This document is a regulatory letter from the FDA determining substantial equivalence, and it does not contain the detailed study results, acceptance criteria, or performance data typically found in a clinical study report.

Therefore, I cannot extract the specific information requested about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily states:

• Device Name: BINDAZYME® Anti-Mitochondria M2 IgGAM EIA Kit
• Intended Use: "This assay is intended for the in-vitro measurement of specific IgG, IgA and IgM autoantibodies against mitochondria present in human serum as an aid in the diagnosis of primary biliary cirrhosis (PBC) when used in conjunction with other clinical observations."
• Regulatory Status: Substantially equivalent to a legally marketed predicate device.
• Product Code: DBM (Anti-mitochondrial antibody immunological test system)
• Regulatory Class: Class II

To provide the information you requested, access to the actual 510(k) submission document or a clinical study report would be necessary.

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