(243 days)
No
The device description details a standard ELISA assay, which is a biochemical test. There is no mention of AI/ML terms, image processing, or data training/testing, which are typical indicators of AI/ML use in medical devices.
No
The device is an ELISA kit for detecting antibodies, which is a diagnostic tool, not a therapeutic intervention.
Yes
The device detects IgG antibodies to cytomegalovirus in human serum, and the evaluation of seroconversion or a significant rise in antibody can aid in the diagnosis of primary, reactivated, or reinfection with cytomegalovirus.
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 only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the 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 (immunological response to infection).
- Device Description: The description details a laboratory test (ELISA) performed on a biological sample (diluted patient serum) using reagents and equipment to measure a biological marker (CMV IgG antibodies). This is the core function of an in vitro diagnostic device.
- Performance Studies: The performance studies describe testing serum samples and comparing the results to another diagnostic test (GULL CMV IgG ELISA Test), which is typical for evaluating the performance of an IVD.
The definition of an In Vitro Diagnostic device is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. This device clearly fits this definition.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
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%.
Predicate Device(s)
Reference Device(s)
Not Found
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
JUL 22 1996
1. SUMMARY OF SAFETY AND EFFECTIVENESS
| DEVICE NAME: | INCSTAR CMV IgG 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 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
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.
3