Search Results

The Ferritin Reagent is for the determination of ferritin concentrations in human serum and plasma on the Beckman Coulter family of AU clinical chemistry analyzers. For in vitro diagnostic use only.

Serum ferritin is an indicator of body iron stores: it has been shown to correlate with stainable bone marrow iron. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

Not Found

This document is an FDA 510(k) clearance letter for the Beckman Coulter Ferritin Reagent (OSR61203). It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study information, acceptance criteria, or performance data that you requested about the device.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the FDA found sufficient evidence that the new device performs as intended and is as safe and effective as a device already on the market. The specific details of how that substantial equivalence was demonstrated are typically found in the 510(k) submission itself, which is not provided in this public clearance letter.

Therefore, I cannot answer your questions based solely on the provided text. The document is primarily a formal notification of clearance, not a technical report of the studies performed.

Ask a specific question about this device