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The TheraTest EL-B2GP1 (IgM, IgG, IgA) is an in vitro diagnostic tests for the measurement of IgM, IgG and IgA vito and homan serum directed against the serum glycoprotein Beta 2 Glycoprotein 1 (82GP1) . This measurement aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus.

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I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets any specific criteria. The document is a 510(k) clearance letter from the FDA for the TheraTest EL-B2GP1 (IgM, IgG, IgA) device, indicating that it has been deemed "substantially equivalent" to a legally marketed predicate device.

The letter explicitly states:

• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the FDA reviewed the premarket notification based on substantial equivalence, not on the basis of new clinical study acceptance criteria or performance metrics directly demonstrating independent efficacy or accuracy as would be presented in a clinical trial report.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, information on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.

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