(87 days)
The test is for the quantitative measurement of the IgG class of auto-antibodies to anti-Thyroid-peroxidase (anti-TPO) in human serum or plasma (EDTA or heparin) to aid in the diagnosis of thyroid disease.
Not Found
The provided document is a 510(k) cleared letter from the FDA for an in vitro diagnostic device, the Abbott AxSYM® anti-Thyroid peroxidase (anti-TPO) Microparticle Enzyme Immunoassay (MEIA). This document does not contain the detailed study information needed to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the FDA found the device to be as safe and effective as a legally marketed predicate device, based on the information provided by the manufacturer in their 510(k) submission. However, the 510(k) clearance letter itself does not include the detailed study report or the data that led to this determination.
To answer your questions, one would need to access the full 510(k) submission (which often includes clinical study reports, analytical validation data, etc.). This information is typically proprietary and not publicly available in detail through the FDA's public database for 510(k) clearance letters.
Therefore, I cannot provide the requested information based on the document you provided.
§ 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).