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The Diastat ™Anti-Thyroid Peroxidase (anti-TPO) test is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection the IgG class of autoantibodies specific for thyroid peroxidase in human serum or EDTA, heparin or citrated plasma. It is intended to aid in the diagnosis of autoimmune thyroid disorders and is not definitive in isolation. Autoantibody levels represent one parameter in a multicriterion diagnostic process.

quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection the IgG class of autoantibodies specific for thyroid peroxidase in human serum or EDTA, heparin or citrated plasma.

The provided document is a 510(k) clearance letter for an in vitro diagnostic device, specifically the Diastat™ Anti-Thyroid Peroxidase (anti-TPO) Elisa Test. This type of document typically focuses on establishing substantial equivalence to a predicate device and does not usually contain the detailed study information (like acceptance criteria, sample sizes, and expert qualifications) that would be found in a clinical study report or a more comprehensive technical document for an AI/ML medical device.

Therefore, the specific information requested in your prompt regarding acceptance criteria and performance studies, particularly in the context of AI/ML devices, cannot be extracted from the provided text because it is not present.

This document confirms the device's classification and lists its intended use, but it doesn't delve into the performance study details for demonstrating accuracy or other metrics in the way an AI/ML device submission would.

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