(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 intended use, device description, or performance studies. The analysis relies on color detection and measurement, not algorithmic interpretation of complex data.
No
This device is an in vitro diagnostic test for detecting antibodies to Toxoplasma gondii, not for treating a condition.
Yes
The stated "Intended Use" clearly indicates that the product helps in the "diagnosis of primary or reactivated infection with Toxoplasma gondii." It detects IgG antibodies to Toxoplasma gondii, which is an immunological response to infection.
No
The device description clearly outlines a laboratory-based ELISA kit involving physical reagents, microtiter wells, and a photometer for detection, 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 clearly states the kit is for the "qualitative and/or semi-quantitative detection of IgG antibodies to Toxoplasma gondii in human serum". This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a medical condition (immunological response to infection with Toxoplasma gondii).
- Device Description: The description details a laboratory test method (ELISA) performed on a biological sample (diluted patient serum).
- Performance Studies: The performance studies describe testing "serum samples" and comparing the results to another ELISA kit, further confirming its use in a laboratory setting for diagnostic purposes.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, urine, or tissue, from the human body to detect diseases, conditions, or infections. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
The INCSTAR Toxoplasma IgG ELISA kit contains instructions and materials for 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 IgG ELISA is of value in the determination of 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 IqG 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, 300 serum samples represented by 269 individuals were tested with the INCSTAR Toxoplasma IgG Kit and results were compared to those results generated from the Gull Toxoplasma IgG ELISA kit. The samples utilized represent a mixed population of infants, transplant 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)
In clinical performance studies, 300 serum samples represented by 269 individuals were tested with the INCSTAR Toxoplasma IgG Kit and results were compared to those results generated from the Gull Toxoplasma IgG ELISA kit. The samples utilized represent a mixed population of infants, transplant 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 98% to 100% and relative specificity of 92% to 99%. In addition, the assay displayed an overall agreement of 96% to 99%.
Correlation, prevalence, cross-reactivity, interference, linearity and precision studies have been conducted and are summarized in the INCSTAR Toxoplasma IgG Kit package insert.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
relative sensitivity of 98% to 100% and relative specificity of 92% to 99%. In addition, the assay displayed an overall agreement of 96% to 99%.
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).
0
DEC 1 6 1996
I. SUMMARY OF SAFETY AND EFFECTIVENESS
| DEVICE NAME: | INCSTAR Toxoplasma IgG 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 ELISA kit contains instructions and materials for 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 IgG ELISA is of value in the determination of 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.
1
I. SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
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 IqG bound to the solid phase.
SAFETY AND EFFECTIVENESS:
The INCSTAR Toxoplasma IgG 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, 300 serum samples represented by 269 individuals were tested with the INCSTAR Toxoplasma IgG Kit and results were compared to those results generated from the Gull Toxoplasma IgG ELISA kit. The samples utilized represent a mixed population of infants, transplant 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 98% to 100% and relative specificity of 92% to 99%. In addition, the assay displayed an overall agreement of 96% to 99%.
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I. SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
Correlation, prevalence, cross-reactivity, interference, linearity and precision studies have been conducted and are summarized in the INCSTAR Toxoplasma IgG Kit package insert.
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