(51 days)
The Immunoglobulin G assay is used for the quantitation of immunoglobulin G in human serum or plasma. Measurement of immunoglobulin G aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin G in the sample.
{
"acceptance_criteria_and_performance": {
"table": [
{
"criterion": "Correlation Coefficient",
"acceptance_criteria": "> 0.99",
"reported_performance": "0.9966"
},
{
"criterion": "Slope (vs. predicate)",
"acceptance_criteria": "Close to 1",
"reported_performance": "0.957"
},
{
"criterion": "Y-intercept (vs. predicate)",
"acceptance_criteria": "Close to 0",
"reported_performance": "40.555 mg/dL"
},
{
"criterion": "Total %CV for Level 1/Panel 401 (Precision)",
"acceptance_criteria": "Low variability",
"reported_performance": "2.1%"
},
{
"criterion": "Total %CV for Level 2/Panel 402 (Precision)",
"acceptance_criteria": "Low variability",
"reported_performance": "1.7%"
},
{
"criterion": "Assay Range",
"acceptance_criteria": "Clinically relevant range",
"reported_performance": "21.0 to 6,147.43 mg/dL"
},
{
"criterion": "Limit of Quantitation (Sensitivity)",
"acceptance_criteria": "Low detection limit",
"reported_performance": "21.0 mg/dL"
}
],
"study_description": "Comparative performance studies were conducted using the AEROSET™ System. The Immunoglobulin G assay method comparison yielded acceptable correlation with the Boehringer Mannheim Immunoglobulin G assay on the Hitachi 717 Analyzer. Precision studies were conducted using the Immunoglobulin G assay, including within-run, between-run, and between-day studies using two levels of control material."
},
"sample_size_test_set": "Not explicitly stated for comparative performance studies. Precision studies used two levels of control material.",
"data_provenance": "Not explicitly stated (e.g., country of origin, retrospective/prospective). Studies were conducted using the AEROSET™ System.",
"number_of_experts_ground_truth": "N/A - This is an in vitro diagnostic assay with a predicate device comparison, not an imaging device requiring expert consensus for ground truth.",
"qualifications_of_experts": "N/A",
"adjudication_method": "N/A",
"mrmc_comparative_effectiveness_study": "No, this is not an MRMC study. This is a substantial equivalence study for an in vitro diagnostic assay comparing performance to a predicate device.",
"standalone_performance_study": "Yes, standalone performance was assessed through precision studies (within-run, between-run, and between-day variability) and the assay range/sensitivity determination.",
"type_of_ground_truth_test_set": "The 'ground truth' for the comparative performance study was the results obtained from the predicate device (Boehringer Mannheim Immunoglobulin G assay on the Hitachi 717 Analyzer). For precision and sensitivity, the ground truth is derived from established laboratory methods and control materials.",
"sample_size_training_set": "Not applicable, as this is an in vitro diagnostic assay not employing machine learning for 'training' in the traditional sense.",
"ground_truth_for_training_set_established": "Not applicable."
}
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).