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The Access Thyroglobulin Antibody II assay is a paramagnetic chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.

The Access Thyroglobulin Antibody II reagents, Thyroglobulin Antibody II calibrators, and the Access Immunoassay analyzers comprise the Access lmmunoassay System for the quantitative determination of thyroglobulin antibody in human serum and plasma.

Here's a breakdown of the acceptance criteria and study information for the Access Thyroglobulin Antibody II for use on the Access Immunoassay Systems, as extracted from the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Summary of Studies" section, which describes the performance characteristics that were measured and deemed acceptable for demonstrating substantial equivalence. Exact numerical acceptance thresholds for each test (e.g., "imprecision must be less than X%") are not explicitly stated as distinct criteria, but the reported performance values are presented as evidence of meeting acceptable levels.

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