(87 days)
The test is for the quantitative measurement of the IgG class of auto-antibodies to anti-Thyroglobulin (anti-Tg) in human serum or plasma (EDTA or heparin) to aid in the diagnosis of thyroid disease
Abbott AxSYM® anti-Thyroglobulin (anti-Tg) Microparticle Enzyme Immunoassay (MEIA)
This document is a 510(k) premarket notification letter from the FDA to Axis-Shield Diagnostics Ltd. regarding the Abbott AxSYM® anti-Thyroglobulin (anti-Tg) Microparticle Enzyme Immunoassay (MEIA). It largely focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This type of detailed performance data and study design information is typically found in the 510(k) summary or full submission, which is not provided in these pages.
§ 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).