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Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg determination is used as an aid in the detection of autoimmune thyroid diseases. The electrochemiluminescence Immunoassay “ECLIA” is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

The Elecsys Anti-Tg Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code.

I am unable to provide a response as the provided text pertains to a 510(k) summary for an in vitro diagnostic device (immunoassay for thyroglobulin antibodies) and does not contain the information required to populate a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or results of comparative effectiveness studies normally associated with AI/ML-driven medical devices. The document describes device comparison to a predicate, changes in calibrator and reagent formulations, and stability data, but not performance metrics such as sensitivity, specificity, or AUC against a ground truth dataset.

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