(28 days)
AIA-PACK FT3 is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine in human serum on TOSOH AIA System analyzers. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "AIA-PACK FT3 Assay." It does not contain the detailed information necessary to complete the requested table and study description regarding acceptance criteria and performance.
The letter explicitly states that the FDA has "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."
This means the clearance is based on substantial equivalence to a predicate device, and the letter itself does not describe new performance studies or acceptance criteria for this specific device. Such information would typically be found in the 510(k) submission itself, not in the clearance letter.
Therefore, I cannot provide the requested information from the given text.
§ 862.1710 Total triiodothyronine test system.
(a)
Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.(b)
Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.