(14 days)
Immunoassay for the in vitro quantitative determination of ferritin in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" us intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.
The Elecsys® Ferritin employs a sandwich test principle with monoclonal antibodies directed against ferritin and with streptavidin microparticles and electrochemiluminescence detection. Total duration of assay: 18 minutes. • 1st Incubation: 15 µl of sample a biotinylated monoclonal ferritin-specific antibody and a monoclonal ferritin-specific antibody labeled with a ruthenium complex react to form a sandwich complex. • 2nd Incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
The provided text is a 510(k) summary for the Elecsys® Ferritin device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information, acceptance criteria, and performance data typically found in a clinical study report or a more comprehensive regulatory submission.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test and training sets, data provenance, expert details, or adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone performance.
- Details on how ground truth was established for training and test sets.
The document is purely a summary for regulatory clearance, stating the device's function and its substantial equivalence to a previously approved device (Enzymun-Test® Ferritin), without going into the specifics of performance studies required to demonstrate that equivalence against pre-defined criteria.
§ 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).