(56 days)
Neometrics' Accuwell™ T4 EIA kits are intended to be used for the quantitative measurement of Thyroxine in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newboros for congenital hypothyroidism.
Not Found
This FDA 510(k) clearance letter (K972974) for the Accuwell™ T4-EIA kit does not contain specific details about acceptance criteria, the study that demonstrates the device meets these criteria, or any of the detailed information requested in the prompt regarding AI/algorithm performance.
The document is a clearance letter stating that the FDA has found the Accuwell™ T4-EIA kit to be "substantially equivalent" to predicate devices already on the market. It outlines the regulatory classification, general controls, and other regulatory requirements. The "Statement of Indications for Use" provides the intended purpose of the device (quantitative measurement of Thyroxine in neonatal dried blood spot samples for congenital hypothyroidism screening).
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or AI-specific performance metrics based on the provided text. This document predates the widespread use of AI in medical devices and focuses on traditional in vitro diagnostic device clearance.
§ 862.1700 Total thyroxine test system.
(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.