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Immulite 2500 OM-MA: For in vitro diagnostic use with the IMMULITE 2500 Analyzer- for the quantitative measurement of CA125 antigen in human serum, as an aid in monitoring the response to therapy for patients with epithelial ovarian cancer and in detecting residual ovarian cancer in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures.

Immulite Tumor Marker Controls: TMC is an assayed, serum-based, tri-level control containing analytes associated with malignancy which are commonly measured by immunoassay. It is intended strictly for in vitro use as an aid in monitoring the day-to-day performance of assays for these constituents.

The IMMULITE 2500 OM-MA Immunoassay is a solid-phase, two-site, chemiluminescent immunometric assay for use with the IMMULITE 2500 Automated Analyzer.

The provided text is a 510(k) summary for the IMMULITE® 2500 OM-MA Immunoassay. It describes the device's intended use and classification, and states that it has been found substantially equivalent to a predicate device (IMMULITE 2000 OM-MA Immunoassay).

However, the document does not contain information about acceptance criteria, detailed study results proving device performance against those criteria, sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other detailed study information, as this information is not present in the provided text.

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