(30 days)
The K-ASSAY® Ferritin (2nd Gen.) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Beckman AU680 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use.
The K-ASSAY® Ferritin Calibrator (2nd Gen.) is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2nd Gen.) assay. For in vitro diagnostic use.
The K-ASSAY® Ferritin (2nd Gen.) assay is a latex enhanced immuno-turbidimetric assay for the quantitative in vitro determination of ferritin levels in serum and plasma (EDTA and heparin) samples.
The K-ASSAY® Ferritin (2nd Gen.) consists of two reagents. Reagent 1 contains HEPES buffer solution (50 mmol/L) and Reagent 2 contains HEPES buffer solution (50 mmol/L) and a solution of latex suspension with mouse monoclonal anti-human ferritin antibodies. Both reagents also contain less than 0:01 w/v% of sodium azide as a preservative.
The K-ASSAY® Ferritin Calibrators (2nd Gen.) are liquid stable products consisting of a human serum matrix and known quantities of human ferritin at 6 levels ranging from 0 -1,000 ng/mL (0, 25, 250, 500, 750, 1,000 ng/mL). The calibrators also contain less than 0.1 w/v% of sodium azide as a preservative.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Precision | Between-lot CV% |
§ 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).