The INCSTAR CMV IgG ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to cytomegalovirus in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgG ELISA test is of value in the determination of immunological response to infection with CMV. The evaluation of parred sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary infection, reactivated infection, or reinfection with cytomegalovirus.

Device Description

The INCSTAR CMV IgG ELISA test kit utilizes the enzyme-linked immunosorbant assay (ELISA) technique for the detection of cytomegalovirus IgG antibodies. Polystyrene microtiter wells are coated with purified CMV antigen. Diluted patient serum is incubated with purified CMV antigen bound to the solid surface of a microtiter well. The CMV antibodies that are present in the patient's serum will be captured by the solid phase. After washing, these complexes bind with horseradish peroxidase labeled antihuman IgG which react with the addition of chromogen (tetramethylbenzidine), resulting in color development. The absorbance of the solution, measured at 450 nm, is directly proportional to the concentration of IgG antibodies to CMV antigen present in the reaction solution.

AI/ML Overview

{
  "acceptance_criteria_and_performance": {
    "table": [
      {
        "criterion": "Relative Sensitivity",
        "acceptance_range": "99% to 100%",
        "reported_performance": "99% to 100%"
      },
      {
        "criterion": "Relative Specificity",
        "acceptance_range": "96% to 99%",
        "reported_performance": "96% to 99%"
      },
      {
        "criterion": "Overall Agreement",
        "acceptance_range": "90% to 100%",
        "reported_performance": "90% to 100%"
      }
    ]
  },
  "study_details": {
    "sample_size_test_set": "308 serum samples representing 296 individuals",
    "data_provenance": "Mixed population of healthy donors, immunocompromised hosts, transplant patients, and patients having various other illnesses. (Country of origin not specified, retrospective implied as samples were collected and then tested)",
    "num_experts_ground_truth": "Not applicable, ground truth established by comparison to a predicate device (GULL CMV IgG ELISA Test) and a commercial CMV IgG ELISA for discrepant results.",
    "qualifications_experts": "Not applicable",
    "adjudication_method": "Discrepant results between the INCSTAR CMV IgG ELISA Kit and the GULL CMV IgG ELISA Test were resolved by a commercial CMV IgG ELISA.",
    "mrmc_comparative_effectiveness_study": "No, this was a device-to-device comparison, not a human reader study.",
    "standalone_performance": "Yes, the study describes the performance of the INCSTAR CMV IgG ELISA Kit in comparison to a predicate device.",
    "type_of_ground_truth": "Comparison to a predicate device (GULL CMV IgG ELISA Test) and a commercial CMV IgG ELISA for resolving discrepancies.",
    "sample_size_training_set": "Not specified; this is likely a locked-down assay, not a machine learning model requiring training data from the clinical study perspective.",
    "how_ground_truth_training_set_established": "Not applicable (as above)."
  }
}

Summary

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K955361

JUL 22 1996

1. SUMMARY OF SAFETY AND EFFECTIVENESS

DEVICE NAME:	INCSTAR CMV IgG ELISA Kit
CLASSIFICATION:	Cytomegalovirus serological reagents21 CFR 866.3175Class II (Performance Standards)
APPLICANT:	INCSTAR Corporation1990 Industrial BoulevardStillwater, Minnesota 55082-0285

INTENDED USE:

DEVICE DESCRIPTION:

{1}------------------------------------------------

. SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

proportional to the concentration of IgG antibodies to CMV antigen present in the reaction solution.

SAFETY AND EFFECTIVENESS:

The INCSTAR CMV IgG ELISA Kit is substantially equivalent (SE) to the GULL CMV IgG ELISA test, 510(k) No. K915892, which has been cleared by the FDA and is currently in U.S. commercial distribution.

In clinical performance studies, 308 serum samples represented by 296 individuals were tested using the INCSTAR CMV IgG ELISA Kit and results were compared to those results generated from the GULL CMV IgG ELISA Test. The samples utilized represent a mixed population of healthy donors. immunocompromised hosts, transplant patients, and patients having various other illnesses. Upon completion of assay correlation, the results (using 95% confidence intervals) demonstrated a relative sensitivity of 99% to 100% and a relative specificity of 96% to 99%. In addition, the assay displayed an overall agreement of 90% to 100%.

Further resolution of discrepant results by a commercial CMV IgG ELISA demonstrated that of the 1 sample positive by the INCSTAR CMV IgG assay but negative by the Gull ELISA kit, 1 was positive by the resolving ELISA assay.

Prevalence, cross-reactivity, interference, linearity and precision studies have been conducted and are summarized in the INCSTAR CMV IgG Kit package insert.

Regulation Number and Section

§ 866.3175 Cytomegalovirus serological reagents.

(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).