FDA 510K for Ferritin Immunological Test System
A Ferritin Immunological Test System measures ferritin levels in blood, serum, or plasma to assess iron status, anemia, and related conditions. Using immunoassay technology (e.g., ELISA or chemiluminescence), it provides quantitative results to help diagnose iron deficiency, hemochromatosis, and inflammation.
Intended Use of Ferritin Immunological Test System
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 anemia.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Ferritin Immunological Test System
FDA 510K for Ferritin Immunological Test System Device Code and Regulation Number
Radioimmunoassay (Two-Site Solid Phase), Ferritin
Intended Use
The Ferritin Assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Ferritin is used as an aid in the diagnosis of iron deficiency or iron overload.
Device Description
The Ferritin Assay is a sandwich immunoenzymatic assay. The Ferritin assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Ferritin assay reagent pack, Ferritin assay calibrators, along with the Wash Buffer II are designed for use with the Access Immunoassay Analyzer in a clinical laboratory setting.
Ferritin, Antigen, Antiserum, Control
Intended Use
Ferritin Assay is a quantitative automated chemiluminescent immunoassay (CLIA) for the in vitro detection of ferritin in human serum, serum separator tubes (SST), or lithium (Li) Heparin plasma to aid in the diagnosis of iron deficiency anemia and iron overload.
Device Description
It is a sandwich chemiluminescence immunoassay. Magnetic particles are coated with a mouse monoclonal antibody, while another monoclonal antibody is linked to an isoluminol derivative. During incubation, ferritin in the sample, calibrators, or controls binds to the coated antibody, and the conjugate then attaches to the bound ferritin. After washing away unbound material, starter reagents trigger a chemiluminescent reaction, producing light measured as relative light units (RLU) by a photomultiplier. The light intensity corresponds to the ferritin concentration in the sample.
Performance Testing (Analytical) for Ferritin Immunological Test System
- Precision
- Linearity
- Limit of blank (LoB)
- Limit of Detection (LoD)
- Limit of Quantitation (LoQ)
- Analytical specificity
- Reference intervals
- Cross reactivity
- Matrix comparison
- Method comparison
Clinical Testing
No Guidance available for 510k submission