(243 days)
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No
The device description details a standard ELISA assay which relies on chemical reactions and optical density measurements, not AI/ML algorithms for interpretation or analysis. The performance studies compare the device to a predicate ELISA, further indicating a traditional laboratory assay. There is no mention of AI, ML, or related concepts in the provided text.
No.
This device is an in-vitro diagnostic test used to detect antibodies to cytomegalovirus, aiding in diagnosis of infection, rather than directly treating or mitigating a disease.
Yes
The device is described as being "of value in the determination of immunological response to infection with CMV" and can "aid in the diagnosis of primary infection, reactivated infection, or reinfection with cytomegalovirus" by detecting IgG antibodies, which directly indicates its use for diagnostic purposes.
No
The device description clearly outlines a physical ELISA kit with reagents, microtiter wells, and a process involving chemical reactions and absorbance measurement, indicating it is a hardware-based diagnostic test kit, not software.
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 IgG antibodies to cytomegalovirus in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a person's health status (presence of CMV antibodies).
- Device Description: The description details a laboratory test method (ELISA) performed on a biological sample (diluted patient serum) using reagents and equipment. This is characteristic of an in vitro diagnostic device.
- Clinical Performance Studies: The document describes clinical studies where human serum samples were tested using the device and compared to another test. This is a standard part of the validation process for IVDs.
The core function of the device is to analyze a biological sample in vitro to diagnose or provide information about a disease or condition (CMV infection), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The INCSTAR CMV IgG "fast" 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 "fast" ELISA test is of value in the determination of immunological response to infection with CMV. The evaluation of paired 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.
Product codes
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Device Description
The INCSTAR CMV IgG "fast" 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.
Mentions image processing
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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
In clinical performance studies, 308 serum samples represented by 296 individuals were tested using the INCSTAR CMV IgG "fast" 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 with other various illnesses.
Summary of Performance Studies
Clinical performance studies were conducted using 308 serum samples from 296 individuals. The INCSTAR CMV IgG "fast" ELISA Kit results were compared to the GULL CMV IgG ELISA Test. The study showed a relative sensitivity of 99% to 100% and a relative specificity of 95% to 100%, with an overall agreement of 90% to 100%. Further resolution of discrepant results by a commercial CMV IgG ELISA showed that of 2 samples positive by INCSTAR but negative by Gull, 1 was positive by the resolving ELISA. Prevalence, cross-reactivity, interference, linearity, and precision studies were conducted and summarized in the package insert.
Key Metrics
relative sensitivity of 99% to 100% and a relative specificity of 95% to 100%. In addition, the assay displayed an overall agreement of 90% to 100%.
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K955 360
| I. | SUMMARY OF SAFETY AND EFFECTIVENESS | |
|---|---|---|
| DEVICE NAME: | INCSTAR CMV IgG “fast” ELISA Kit | |
| CLASSIFICATION: | Cytomegalovirus serological reagents | |
| 21 CFR 866.3175 | ||
| Class II (Performance Standards) | JUL 22 1996 | |
| APPLICANT: | INCSTAR Corporation | |
| 1990 Industrial Boulevard | ||
| Stillwater, Minnesota 55082-0285 |
INTENDED USE:
The INCSTAR CMV IgG "fast" 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 "fast" ELISA test is of value in the determination of immunological response to infection with CMV. The evaluation of paired 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 "fast" 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.
1
l. SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
SAFETY AND EFFECTIVENESS:
The INCSTAR CMV IgG "fast" 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 "fast" 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 with other various 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 95% to 100%. 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 2 samples positive by the INCSTAR CMV IqG "fast" assay but negative by the Gull ELISA kit, 1 was positive by the resolving ELISA assav.
Prevalence, cross-reactivity, interference, linearity and precision studies have been conducted and are summarized in the INCSTAR CMV IgG "fast" ELISA Kit package insert.
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