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The Olympus fT4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human serum/plasma using the Olympus AU3000i™ Immunoassay System. Measurements obtained by this device are used in the diagnosis and treatment of thyroid disease. For in vitro diagnostic use only.

The Olympus T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine levels in human serum/plasma using the Olympus AU3000i™ Immunoassay System. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. For in vitro diagnostic use only.

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This document is a 510(k) premarket notification decision letter from the FDA regarding the Olympus FT4 Free thyroxine and Olympus T4 Total thyroxine test systems. It does not contain the specific details about acceptance criteria, device performance, study design, or ground truth establishment that you are requesting.

The letter primarily states that the devices are substantially equivalent to legally marketed predicate devices and can therefore be marketed. It outlines regulatory requirements but does not delve into the technical validation studies.

To answer your questions, you would need to refer to the actual 510(k) premarket notification submission itself, which typically includes detailed study reports, performance data, and other validation information. This letter only provides the FDA's decision based on that submission.

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