(253 days)
The INCSTAR Toxoplasma IgM Capture ELISA kit contains instructions and materials for the qualitative detection of IgM antibodies to Toxoplasma gondii in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active Toxoplasma gondii infection. This product is not FDA cleared for use in testing (i.e., screening) blood or plasma donors.
The INCSTAR Toxoplasma IgM Capture ELISA Kit utilizes the enzyme-linked immunosorbent assay (ELISA) based on the antibody capture technique. Diluted patient serum is incubated with monoclonal mouse antibody against human IgM (u chain specific) bound to the solid surface of the microtiter well. : Patient IgM is "captured" by the surface bound antibody. The presence of patient anti-Toxoplasma IgM antibodies are then "detected" and bound by Toxoplasma antigen which is linked to an anti-Toxoplasma antibody conjugated to horseradish peroxidase. Bound horseradish peroxidase is reacted with chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm / 630 nm, is directly proportional to the concentration of IgM to Toxoplasma antigen present in the reaction solution.
{
"1": {
"table_of_acceptance_criteria_and_reported_device_performance": {
"Acceptance Criteria": [
"Relative sensitivity: 91% to 99% (95% confidence intervals)",
"Relative specificity: 99% to 100% (95% confidence intervals)",
"Overall agreement: 97% to 100% (95% confidence intervals)"
],
"Reported Device Performance": [
"Relative sensitivity: 91% to 99%",
"Relative specificity: 99% to 100%",
"Overall agreement: 97% to 100%"
]
},
"sample_size_test_set_data_provenance": "406 serum samples from 375 individuals. The data provenance is not explicitly stated as retrospective or prospective, nor the country of origin, but it represents a \"mixed population of healthy donors, transplant patients, immunocompromised hosts, pregnant women, Toxoplasma proven individuals, and patients having various other illnesses.\"",
"number_of_experts_ground_truth_test_set_qualifications": "Not applicable. The ground truth for the test set was established by comparison to a cleared predicate device (BioWhittaker TOXOCAP-M ELISA kit), not by expert consensus.",
"adjudication_method_test_set": "Not applicable. The ground truth for the test set was established by comparison to a cleared predicate device, not through expert adjudication.",
"multi_reader_multi_case_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a diagnostic kit, not an AI-assisted interpretation system for human readers.",
"standalone_algorithm_only_performance": "Yes, a standalone performance study was done. The study compares the performance of the INCSTAR Toxoplasma IgM Capture ELISA Kit to a predicate device, which inherently evaluates the algorithm (kit) on its own.",
"type_of_ground_truth_used": "Comparative ground truth based on a predicate device (BioWhittaker TOXOCAP-M ELISA kit).",
"sample_size_training_set": "Not applicable. The document describes a diagnostic kit, and the performance study is a validation study comparing it to a predicate device, not a study involving iterative training and testing of a machine learning model. Therefore, a distinct 'training set' in the machine learning sense is not mentioned or relevant to the described study.",
"how_ground_truth_for_training_set_established": "Not applicable, as there is no training set described in the context of a machine learning model."
}
}
{0}------------------------------------------------
1<963288
MAY - 1 1997
SUMMARY OF SAFETY AND EFFECTIVENESS l.
| DEVICE NAME: | INCSTAR Toxoplasma IgM Capture ELISA Kit |
|---|---|
| CLASSIFICATION: | Toxoplasma gondii Serological Reagents21 CFR 866.3780Class II (Performance Standards) |
| APPLICANT: | INCSTAR Corporation1990 Industrial BoulevardStillwater, Minnesota 55082-0285 |
INTENDED USE:
The INCSTAR Toxoplasma IgM Capture ELISA kit contains instructions and materials for the qualitative detection of IgM antibodies to Toxoplasma gondii in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active Toxoplasma gondii infection. This product is not FDA cleared for use in testing (i.e., screening) blood or plasma donors.
DEVICE DESCRIPTION:
The INCSTAR Toxoplasma IgM Capture ELISA Kit utilizes the enzyme-linked immunosorbent assay (ELISA) based on the antibody capture technique. Diluted patient serum is incubated with monoclonal mouse antibody against human IgM (u chain specific) bound to the solid surface of the microtiter well. : Patient IgM is "captured" by the surface bound antibody. The presence of patient anti-Toxoplasma IgM antibodies are then "detected" and bound by Toxoplasma antigen which is linked to an anti-Toxoplasma antibody conjugated to horseradish peroxidase. Bound horseradish peroxidase is reacted with chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm / 630 nm, is directly proportional to the concentration of IgM to Toxoplasma antigen present in the reaction solution.
2
{1}------------------------------------------------
SUMMARY OF SAFETY AND EFFECTIVENESS (continued) l.
SAFETY AND EFFECTIVENESS:
The INCSTAR Toxoplasma IgM Capture ELISA Kit is substantially equivalent (SE) to the BioWhittaker TOXOCAP-M ELISA test which has been cleared by the FDA and is currently in U.S. commercial distribution.
In clinical performance studies, 406 serum samples represented by 375 individuals were tested with the INCSTAR Toxoplasma IgM Capture ELISA kit and results were compared to those results generated from the BioWhittaker TOXOCAP-M ELISA kit. The samples utilized represent a mixed population of healthy donors, transplant patients, immunocompromised hosts, pregnant women, Toxoplasma proven individuals, and patients having various other illnesses. Upon completion of assay correlation, the results (using 95% confidence intervals) demonstrated relative sensitivity of 91% to 99% and relative specificity of 99% to 100%. In addition, the assay displayed an overall agreement of 97% to 100%.
Correlation, prevalency, cross-reactivity, interference, IgM specificity and precision studies have been conducted and are summarized in the INCSTAR Toxoplasma IgM Capture Kit package insert.
చి
§ 866.3780
Toxoplasma gondii serological reagents.(a)
Identification. Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toToxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.(b)
Classification. Class II (performance standards).