(90 days)
The Atellica™ IM Ferritin (Fer) assay is for in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma (EDTA and lithium heparin) using the Atellica™ IM Analyzer. This assay can be used as an aid in the diagnosis of iron deficiency anemia and iron overload.
The Atellica Ferritin Assay kit includes the following components: Lite Reagent: 5.0 mL/reagent pack. Contains Goat polyclonal anti-ferritin antibody (~0.64 µg/mL) labeled with acridinium ester in HEPES buffer; protein stabilizers; sodium azide (
Here's a breakdown of the acceptance criteria and study details for the Atellica IM Ferritin Assay, based on the provided document:
Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | CLSI EP05-A3 guidelines (Evaluation of Precision Performance of Quantitative Measurement Methods) | Repeatability (Within-run): CV ranges from 1.2% to 3.5% for samples (4.2 ng/mL to 1453.6 ng/mL) and 1.2% to 1.6% for controls (51.8 ng/mL to 374.0 ng/mL). |
| Within-Lab (Total Imprecision): CV ranges from 4.0% to 7.2% for samples and 4.5% to 5.5% for controls. | ||
| Linearity/Assay Reportable Range | CLSI EP06-A (linearity of Quantitative Measurement Procedures). Implied: Acceptable percentage difference between observed and predicted values. | The linearity data supports an analytical measuring range of 0.9 - 1650 ng/mL. |
| Predicted % Difference (Y-Ŷ)/Ŷ*100: values ranged from -8.88% to 9.47% (excluding the lowest observed value of 0.20 ng/mL which was |
§ 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).