(45 days)
Free T4 test device is an in vitro diagnostic test system for the quantitative determination of circulating Free T4 (non-protein bound Thyroxine) in human serum. It is intended strictly for invitro diagnostic use as an aid to clinical diagnosis of thyroid diseases.
Not Found
This FDA 510(k) clearance letter dated April 5, 2002, for "Monobind, Free T4 (Thyroxine) Microwell EIA" does not contain the detailed information necessary to answer the questions about acceptance criteria and study particulars for a medical device.
Specifically, the document is a clearance letter indicating the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It does not include the actual performance data, study design, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment methods that would typically be part of a submission.
Therefore, I cannot provide the requested information from the given text.
To answer your questions, I would need access to the actual 510(k) submission document or a summary thereof, which would contain the performance study details presented by Monobind.
§ 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.