(163 days)
AIA-PACK TPOAb is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroid peroxidase antibodies (TPOAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves' disease and Hashimoto's disease.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the "AIA-PACK TPOAb Assay". It approves the device for marketing and states its intended use. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information based on the provided text. The document is primarily an approval letter and an "Indication for Use Statement," not a study report or a detailed description of validation.
To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a validation protocol.
§ 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).