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A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

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The provided document is a 510(k) clearance letter from the FDA for a device called "OptiCoat T, EIA Kit" (also referred to as "T4 EIA Kit"). This letter does not contain information about acceptance criteria or a study proving the device meets those criteria.

Instead, it's a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

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This document is an FDA 510(k) clearance letter for the OptiCoat™ T3 EIA Kit, dated December 22, 1998. It primarily addresses the regulatory approval of the device and does not contain detailed information about the acceptance criteria or the specific study that proves the device meets those criteria.

Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its market clearance, but it does not include the performance data of the device itself.

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