(23 days)
Reagent for the determination of ferritin concentrations in human serum using the Olympus family of clinical chemistry analyzers. Serum ferritin is an indicator of body iron stores: it has been shown to correlate with stainable bonemarrow iron. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
Olympus Ferritin Reagent
This document is a 510(k) premarket notification approval letter for the Olympus Ferritin Reagent. It does not contain information about acceptance criteria or a study proving that a device (in the sense of a diagnostic algorithm or imaging system) meets acceptance criteria.
The document discusses a reagent used in a laboratory test for ferritin concentrations. The FDA's determination is based on the substantial equivalence of this reagent to a legally marketed predicate device, not on specific performance criteria demonstrated by a clinical study of an AI-powered device or imaging system.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) because it is not present in the provided text.
§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).