RDI HSFERRITIN KIT

• K Number: K053211
• Device Name: RDI HSFERRITIN KIT
• Manufacturer: REFERENCE DIAGNOSTICS, INC.
• Date Cleared: 2006-03-13 ( 117 days)
• Product Code: DBF
• Regulation Number: 866.5340
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: N/A

Intended Use

For in vitro diagnostic use only. The RDI Ferritin Kit is for the quantitative determination of Ferritin in luman serum or plasma by immunoturbidimetric measurement.

Measurement of ferritin is useful in assessing iron stores and in the evaluation of iron deficiency anemia and hemochromatosis.

Device Description

Not Found

AI/ML Overview

The provided text is a summary of a premarket notification for the RDI Ferritin Kit, which is an in vitro diagnostic device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Device Name: RDI Ferritin Kit
• Regulation Information: 21 CFR § 866.5340, Regulation Name: Ferritin Immunological Test System, Regulatory Class: II, Product Code: DBF
• FDA Determination: Substantial equivalence to legally marketed predicate devices, allowing the device to be marketed.
• Indications for Use: Quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement, useful in assessing iron stores and evaluating iron deficiency anemia and hemochromatosis.

Therefore, I cannot provide the requested information as it is not present in the given text.

Regulation Number and Section

§ 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).