(37 days)
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:
| Acceptance Criteria Category | Specific Metric | Reported Device Performance (VIRGO® pANCA Kit) |
|---|---|---|
| Precision (Inter-assay) | %CV (OD) | Range from 4.2% to 11.0% |
| %CV (Units) | Range from 6.3% to 11.7% | |
| Cutoff Serum %CV | 10.1% | |
| Positive Control %CV | 2.4% | |
| Precision (Intra-assay) | %CV (OD) | Range from 4.0% to 8.5% |
| Cutoff Serum %CV | 6.4% | |
| Positive Control %CV | 4.3% | |
| Comparison Testing (Relative Sensitivity vs. Predicate) | pANCA Panel 1 | 100.0% (21/21), 0.85 CI: 84.5% to 100% |
| pANCA Panel 2 | 100.0% (40/40), 0.88 CI: 91.2% to 100% | |
| Comparison Testing (Relative Specificity vs. Predicate) | Normals | 100% (62/62), 4.8 CI: 94.2% to 100% |
| Interfering Substances | Hemoglobin concentration | No significant effect ( |
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).