(253 days)
Not Found
Not Found
No
The device description details a standard ELISA assay, which is a biochemical test. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis of results is based on absorbance measurements, not algorithmic interpretation.
No.
This device is an in-vitro diagnostic (IVD) test used to detect antibodies for diagnostic purposes, not to treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the kit "can be used as an aid in the diagnosis of current or recent active Toxoplasma gondii infection." This directly indicates its role in diagnosis.
No
The device description clearly outlines a physical ELISA kit with reagents, microtiter wells, and a process involving chemical reactions and absorbance measurements, indicating it is a hardware-based diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative detection of IgM antibodies to Toxoplasma gondii in human serum". This indicates the device is used to test a sample taken from the human body (in vitro) to provide information about a medical condition (diagnosis of current or recent active Toxoplasma gondii infection).
- 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 another diagnostic test.
These characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
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.
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, 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.
Key Metrics
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%.
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
1