(31 days)
Free T4 EIA can be used as an in vitro Diagnostic test system for the quantitative determination of nonprotein-bound (Free) circulating Thyroxine (T4) in human serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. It is not suitable for use in determination of thyroid status in neonatal patients.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Free Thyroxine (FT4) Microwell EIA" by Biomerica, Inc. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed.
However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or details about comparative effectiveness studies (MRMC) or standalone algorithm performance.
The letter is a regulatory document indicating clearance, not a technical report detailing the device's validation studies. Therefore, I cannot provide the requested information based on the given input.
§ 862.1695 Free thyroxine test system.
(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.