(61 days)
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.
§ 866.5870 Thyroid autoantibody immunological test system.
(a)
Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.(b)
Classification. Class II (performance standards).