Diazyme Laboratories, a Division of General Atomics located in Poway, California has announced that it has received 510(K) marketing clearance from the U.S. Food and Drug Administration (FDA) for its Ferritin assay used in clinical chemistry analyzers. This dual liquid stable reagent system can be utilized for the quantitative determination of ferritin in serum and plasma samples and is intended for in vitro diagnostic use only.
This Latex-Enhanced Immunoturbidimetric assay allows for highly reliable, precise and complete test results, with minimal sample volumes. Furthermore, the assay is designed to work on most high throughput clinical chemistry analyzers, providing faster results for improved laboratory workflow.
Ferritin is a protein that stores iron and releases it when the body needs it. The ferritin blood test is conducted to measure the amount of iron stored in the body. The detection of elevated or low levels of ferritin in the blood helps in the diagnosis of various diseases. Low levels of ferritin can indicate iron deficiency anemia, and inflammation, while high levels of ferritin can mean an iron storage disorder. Normal ferritin concentrations vary by age and sex, with men having higher levels of this protein.
Managing Director of Diazyme Laboratories Dr. Chong Yuan says, “Diazyme’s Ferritin Assay provides an effective test method for laboratories of virtually all sizes. The sensitivity of the assay allows ferritin levels to be measured very efficiently and effectively. This high-throughput liquid stable assay provides precise test results, is user friendly, cost-effective and has excellent correlation to the existing commercial methods”.