Search Results

This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection of altoantilian to the antigen Myeloperoxidase (MPO) in human serum. The presence of MPO antibodies, in combination with dinical observations and other serological tests, can aid in the dlagnosis of polyarterits, necrotizing glomerulonephritis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (ANCA).

An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of autoantibodies to the antigen myeloperoxidase in human serum.

The ELISA methodology is commonly used for serum antibody evaluations. Purified MPO antigen has been attached to the inner surfaces of the microwell plate. During the initial incubation step, antibodies in patient serum bind specifically to the immobilized antigen and remain in place after a wash step.

A second antibody which is conjugated to horseradish peroxidase (HRP) is used to recognize the "heavy + light" chain regions of the patient's antibodies remaining after the wash step. In the wells where the second antibody remains bound, the conjugated HRP catalyzes a color change in the substrate, tetramethyl benzidine (TMB). After the reaction is stopped, the color is read in an EIA Plate reader.

Here's a breakdown of the acceptance criteria and study details for the K973824 device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for K973824 primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined acceptance criteria with numerical targets. However, the performance data presented implies the following implicit criteria for comparison with the predicate:

Ask a specific question about this device