(260 days)
No
The device description details a standard ELISA assay, and there is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is an in vitro diagnostic (IVD) test kit used to detect antibodies for aid in diagnosis, not to treat or cure a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test "can be used as an aid in the diagnosis of current or recent active CMV infection."
No
The device description clearly outlines a physical ELISA test kit with reagents, microtiter wells, and a process involving color development and absorbance measurement, indicating it is a hardware-based diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is for the "qualitative and/or semi-quantitative detection of IgM antibodies to cytomegalovirus in human serum." It also states that it can be used "as an aid in the diagnosis of current or recent active CMV infection." This clearly indicates that the device is intended to be used in vitro (outside the body) to examine specimens (human serum) to provide information for diagnostic purposes.
- Device Description: The description details a laboratory test method (ELISA) performed on a biological sample (diluted patient serum).
- Performance Studies: The performance studies involve testing human serum samples and comparing the results to other diagnostic tests.
These characteristics align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The INCSTAR CMV IgM Capture ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgM antibodies to cytomegalovirus in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active CMV infection. The evaluation of paired CMV IgM sera can also aid in determining the stage of active CMV infection.
Product codes
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Device Description
The INCSTAR CMV IgM Capture ELISA test kit utilizes the enzyme-linked immunosorbent assay (ELISA) based on the antibody capture technique. Diluted patient serum is incubated with mouse monoclonal antibody against human IgM (u chain specific) bound to the solid surface of a microtiter well. Patient IgM is "captured" by the surface bound antibody. The presence of patient anti-CMV IgM antibodies are then "detected" and bound by CMV antigen which is linked to an anti-CMV monoclonal 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, is directly proportional to the concentration of IgM to CMV antigen present in the reaction solution
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
In clinical performance studies, 529 serum samples represented by 474 individuals were tested using the INCSTAR CMV IgM Capture ELISA Kit and results were compared to those results generated from the BioWhittaker CMV CAP-M ELISA Test. The samples utilized represent a mixed population of healthy donors, immunocompromised hosts, transplant patients, congenital CMV babies, and patients having various other illnesses. Upon completion of assay correlation, the results (using 95% confidence intervals) demonstrated a relative sensitivity of 88% to 97% and a relative specificity of 92% to 97%. In addition, the assay displayed an overall agreement of 92% to 96%.
Further resolution of discrepant results by a commercial CMV IgM ELISA method [Gull CMV IgM ELISA (510(K) No. K903807)] demonstrated that of the 21 samples positive by the INCSTAR CMV IgM Capture ELISA assay but negative by the reference ELISA assay, 17 samples contained sufficient quantities for resolution and 10 were found to be positive by the resolving ELISA method. Of the 10 samples negative by the INCSTAR CMV IgM Capture ELISA assay but positive by the reference ELISA assay, 9 samples contained sufficient quantities for resolution and 8 were found to be negative by the resolving ELISA method.
Prevalency, cross-reactivity, interference, linearity and precision studies have been conducted and are summarized in the INCSTAR CMV IgM Capture Kit package insert.
Key Metrics
relative sensitivity of 88% to 97% and a relative specificity of 92% to 97%. In addition, the assay displayed an overall agreement of 92% to 96%.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
001 17 1996
SUMMARY OF SAFETY AND EFFECTIVENESS 1.
DEVICE NAME: INCSTAR CMV IgM Capture ELISA Kit
CLASSIFICATION: Cytomegalovirus serological reagents 21 CFR 866.3175 Class II (Performance Standards)
- APPLICANT: INCSTAR Corporation 1990 Industrial Boulevard Stillwater, Minnesota 55082-0285
INTENDED USE:
The INCSTAR CMV IgM Capture ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgM antibodies to cytomegalovirus in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active CMV infection. The evaluation of paired CMV IgM sera can also aid in determining the stage of active CMV infection.
DEVICE DESCRIPTION:
The INCSTAR CMV IgM Capture ELISA test kit utilizes the enzyme-linked immunosorbent assay (ELISA) based on the antibody capture technique. Diluted patient serum is incubated with mouse monoclonal antibody against human IgM (u chain specific) bound to the solid surface of a microtiter well. Patient IgM is "captured" by the surface bound antibody. The presence of patient anti-CMV IgM antibodies are then "detected" and bound by CMV antigen which is linked to an anti-CMV monoclonal 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, is directly proportional to the concentration of IgM to CMV antigen present in the reaction solution
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l. SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
SAFETY AND EFFECTIVENESS:
The INCSTAR CMV IgM Capture ELISA Kit is substantially equivalent (SE) to the BioWhittaker CMV CAP-M ELISA test, 510(k) No K896295, which has been cleared by the FDA and is currently in U.S. commercial distribution.
In clinical performance studies, 529 serum samples represented by 474 individuals were tested using the INCSTAR CMV IgM Capture ELISA Kit and results were compared to those results generated from the BioWhittaker CMV CAP-M ELISA Test. The samples utilized represent a mixed population of healthy donors, immunocompromised hosts, transplant patients, congenital CMV babies, and patients having various other illnesses. Upon completion of assay correlation, the results (using 95% confidence intervals) demonstrated a relative sensitivity of 88% to 97% and a relative specificity of 92% to 97%. In addition, the assay displayed an overall agreement of 92% to 96%.
Further resolution of discrepant results by a commercial CMV IgM ELISA method [Gull CMV IgM ELISA (510(K) No. K903807)] demonstrated that of the 21 samples positive by the INCSTAR CMV IgM Capture ELISA assay but negative by the reference ELISA assay, 17 samples contained sufficient quantities for resolution and 10 were found to be positive by the resolving ELISA method. Of the 10 samples negative by the INCSTAR CMV IgM Capture ELISA assay but positive by the reference ELISA assay, 9 samples contained sufficient quantities for resolution and 8 were found to be negative by the resolving ELISA method.
Prevalency, cross-reactivity, interference, linearity and precision studies have been conducted and are summarized in the INCSTAR CMV IgM Capture Kit package insert.
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