(117 days)
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No
The device description details a standard ELISA assay, which is a biochemical method for detecting antibodies. There is no mention of AI or ML in the description, intended use, or performance studies.
No.
This device is an in vitro diagnostic test designed to detect antibodies to Toxoplasma gondii to aid in the diagnosis of infection, not to treat or cure a condition.
Yes
The device detects IgG antibodies to Toxoplasma gondii to aid in the determination of immunological response to infection and diagnosis of primary or reactivated infection. This falls under the definition of a diagnostic device, as it is used to identify the presence of a disease or condition.
No
The device description clearly outlines a laboratory-based ELISA kit that involves physical reagents, microtiter wells, and a photometer for color detection, indicating it is a hardware-based diagnostic test, not software only.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the kit is for the "qualitative and/or semi-quantitative detection of IgG antibodies to Toxoplasma gondii in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique." 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 method (ELISA) performed on a biological sample (diluted patient serum) using reagents and a solid phase (microtiter wells coated with antigen). This is a classic description of an in vitro diagnostic test.
- Clinical Performance Studies: The studies described involve testing human serum samples and comparing the results to a predicate device, which is typical for evaluating the performance of an IVD.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device clearly fits this description by detecting antibodies in serum to aid in the diagnosis of Toxoplasma gondii infection.
N/A
Intended Use / Indications for Use
The INCSTAR Toxoplasma IgG "fast" ELISA kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to Toxoplasma gondii in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IqG "fast" ELISA test is of value in the determination immunological response to infection with Toxoplasma gondii. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary or reactivated infection with Toxoplasma gondii. This product is not FDA cleared for use in testing (i.e., screening) blood or plasma donors.
Product codes
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Device Description
The method for the determination of specific anti-Toxoplasma IgG utilizes the enzyme-linked immunosorbent assay (ELISA) technique. Polystyrene microtiter wells are coated with purified Toxoplasma gondii antigen. Diluted patient serum is incubated with the purified antigen bound to the solid surface of a microtiter well. The Toxoplasma IgG antibodies present in a patient's serum will be captured by the solid phase. After washing, affinity purified polyclonal goat antihuman IgG (Fc) antibodies conjugated to horseradish peroxidase are added to the well. After this incubation, chromogen containing tetramethylbenzidine is added. Enzyme action on the chromogen results in a color reaction. The color can be detected with a photometer at a dual wavelength of 450 nm / 630 nm. The measured enzyme activity is directly proportional to the concentration of specific anti-Toxoplasma IgG bound to the solid phase.
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, 294 serum samples represented by 263 individuals were tested with the INCSTAR Toxoplasma IgG "fast" Kit and results were compared to those results generated from the Gull Toxoplasma IgG ELISA The samples utilized represent a mixed population of infants, transplant kit. patients, immunocompromised hosts, pregnant women being screened for Toxoplasmosis, and patients having various other illnesses.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance studies were conducted using 294 serum samples (263 individuals). The results showed a relative sensitivity of 97% to 100% and relative specificity of 95% to 100%, with an overall agreement of 97% to 100% (using 95% confidence intervals). Correlation, prevalency, cross-reactivity, interference, linearity and precision studies have also been conducted and are summarized in the INCSTAR Toxoplasma IgG "fast" Kit package insert.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
relative sensitivity of 97% to 100% and relative specificity of 95% to 100%. In addition, the assay displayed an overall agreement of 97% to 100%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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SUMMARY OF SAFETY AND EFFECTIVENESS 1.
DEC 16 1996
| DEVICE NAME: | INCSTAR Toxoplasma IgG "fast" ELISA Kit |
|---|---|
| CLASSIFICATION: | Toxoplasma gondii Serological Reagents |
| 21 CFR 866.3780 | |
| Class II (Performance Standards) | |
| APPLICANT: | INCSTAR Corporation |
| 1990 Industrial Boulevard | |
| Stillwater, Minnesota 55082-0285 |
INTENDED USE:
The INCSTAR Toxoplasma IgG "fast" ELISA kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to Toxoplasma gondii in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IqG "fast" ELISA test is of value in the determination immunological response to infection with Toxoplasma gondii. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary or reactivated infection with Toxoplasma gondii. This product is not FDA cleared for use in testing (i.e., screening) blood or plasma donors.
DEVICE DESCRIPTION:
The method for the determination of specific anti-Toxoplasma IgG utilizes the enzyme-linked immunosorbent assay (ELISA) technique. Polystyrene microtiter wells are coated with purified Toxoplasma gondii antigen. Diluted patient serum is incubated with the purified antigen bound to the solid surface of a microtiter well. The Toxoplasma IgG antibodies present in a patient's serum will be captured by the solid phase. After washing, affinity purified polyclonal goat antihuman IgG (Fc) antibodies conjugated to horseradish peroxidase are added to the well. After this incubation, chromogen containing tetramethylbenzidine is added. Enzyme action on the chromogen results in a color reaction. The color can be detected with a photometer at a dual wavelength of 450 nm / 630 nm.
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SUMMARY OF SAFETY AND EFFECTIVENESS (continued) 1.
The measured enzyme activity is directly proportional to the concentration of specific anti-Toxoplasma IgG bound to the solid phase.
SAFETY AND EFFECTIVENESS:
The INCSTAR Toxoplasma IgG "fast" ELISA Kit is substantially equivalent (SE) to the Gull Toxoplasma IgG ELISA test, 510(k) No. K915891, which has been cleared by the FDA and is currently in U.S. commercial distribution.
In clinical performance studies, 294 serum samples represented by 263 individuals were tested with the INCSTAR Toxoplasma IgG "fast" Kit and results were compared to those results generated from the Gull Toxoplasma IgG ELISA The samples utilized represent a mixed population of infants, transplant kit. patients, immunocompromised hosts, pregnant women being screened for Toxoplasmosis, and patients having various other illnesses. Upon completion of assay correlation, the results (using 95% confidence intervals) demonstrated relative sensitivity of 97% to 100% and relative specificity of 95% to 100%. In addition, the assay displayed an overall agreement of 97% to 100%.
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Correlation, prevalency, cross-reactivity, interference, linearity and precision studies have been conducted and are summarized in the INCSTAR Toxoplasma IgG "fast" Kit package insert.
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