(23 days)
The Access HYPERsensitive hTSH Assay provides in vitro quantitative measurement of the human thyroid-stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH Assay is indicated for use with patients where an assessment of their thyroid status is desired. This assay is capable of providing 3rd generation (HYPERsensitive hTSH) and/or the 2nd generation (Fast hTSH) results.
The Access® hTSH assay consists of the reagent pack and calibrators. Other items needed to perform the assay include the diluent, substrate and wash buffers.
This document is a 510(k) summary for the Access HYPERsensitive hTSH Assay. It does not contain information about acceptance criteria or specific studies detailing device performance against those criteria. The provided text primarily focuses on the device description, intended use, technological characteristics, and its substantial equivalence to previously cleared devices.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is essentially a regulatory filing, not a scientific publication detailing performance studies.
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.