(158 days)
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No
The summary describes a standard enzyme immunoassay (EIA) for detecting antibodies, with no mention of AI/ML terms, image processing, or descriptions of training/test sets indicative of AI/ML model development.
No.
Explanation: The device is designed for the detection of antibodies to aid in diagnosis, not for treatment or therapy.
Yes
The device is described as aiding in the "diagnosis of primary infection" through the detection of antibodies.
No
The device description clearly states it is a "solid phase enzyme immunoassay (EIA), which is performed in microwells," indicating it is a physical kit with reagents and components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "For the detection of human IgG antibodies to toxoplasma virus in human serum by enzyme immunoasay, to aid in the serological assessment of single samples and the diagnosis of primary infection in paired sera..." This describes a test performed on a biological sample (human serum) outside of the body to provide information about a person's health status (presence of antibodies to a virus).
- Device Description: The description details a "solid phase enzyme immunoassay (EIA), which is performed in microwells... to detect IgG antibodies which are directed against Toxoplasma gondii in human serum." This further confirms it's a laboratory-based test using reagents to analyze a biological sample.
These characteristics are the defining features of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the detection of human IgG antibodies to toxoplasma virus in human serum by enzyme immunoasay, to aid in the serological assessment of single samples and the diagnosis of primary infection in paired sera through the detection of Seroconversion of Toxoplasma specific IgG antibody. These reagents have not received FDA clearance for use in testing blood or plasma donors.
Product codes
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Device Description
he SeraQuest™ Toxoplasma IgG test is a solid phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty-minute incubations. It has been developed to detect IgG antibodies which are directed against Toxoplasma gondii in human serum.
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
One hundred and forty-three sera from normal blood donors were assayed for the presence of Toxoplasma IgG antibodies, using the SeraQuest™ Toxoplasma IgG test and the INCSTAR Toxoplasma IgG Clin-ELISA™ test.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
One hundred and forty-three sera from normal blood donors were assayed for the presence of Toxoplasma IgG antibodies, using the SeraQuest™ Toxoplasma IgG test and the INCSTAR Toxoplasma IgG Clin-ELISA™ test. Of the one hundred and forty-three specimens tested, forty-one were positive, and ninety-six were negative, by both tests. Of the six remaining specimens, three were positive in The SeraQuest™ test and negative in the comparative test, one was positive in the SeraQuest™ test and equivocal in the comparative test, and two specimens were equivocal in the SeraQuest™ test and negative in the comparative test. Excluding the equivocal results, the sensitivity and specificity, of the SeraQuest™ test relative to the INCSTAR Toxoplasma IgG Clin-ELISA™ test, was 98.8 % to 100 % (95 % C.I.) and 93.6 % to 100 % (95 % C.I.), respectively. The overall agreement was 95.5 % to 100 % (95 % C.I.).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative sensitivity√ 98.8 to 100
Relative specificity√ 93.6 to 100
Overall agreement√ 95.5 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.
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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
JUN 17 1996
APPENDIX 8.
Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. 183
510(k) SUMMARY
Quest International, Inc. Applicant: 1938 N.E. 148th Terrace North Miami, FL 33181
December 26, 1995 Date prepared:
Contact person: Robert A. Cort. President
Telephone: (305) 948-8788
Telefax: (305) 948-4876
Device: SeraQuest™ Toxoplasma IgG
Device Classification: Class II (performance standards)
Device Name: Toxoplasma serological reagents (21CFR § 866.3780) .
Description:
he SeraQuest™ Toxoplasma IgG test is a solid phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty-minute incubations. It has been developed to detect IgG antibodies which are directed against Toxoplasma gondii in human serum.
Principle:
Diluted samples are incubated in antigen-coated wells. Toxoplasma antibodies (if present) are immobilized in the wells. Residual sample is eliminated by washing and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to Toxoplasma are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow end product which is read photometrically.
Intended Use:
For the detection of human IgG antibodies to toxoplasma virus in human serum by enzyme immunoasay, to aid in the serological assessment of single samples and the diagnosis of primary infection in paired sera through the detection of Seroconversion of Toxoplasma specific IgG antibody. These reagents have not received FDA clearance for use in testing blood or plasma donors.
Predicate device:
The SeraQuest™ Toxoplasma IgG test has been shown to be substantially equivalent to the xoplasma IgG Clin-ELISA™ kit, INCSTAR Corporation, Stillwater Minnesota.
1
| Summary of technological characteristics: | ||
|---|---|---|
| Characteristic | SeraQuest™ Toxoplasma IgG | INCSTAR Toxo IgG Clin-ELISA™ |
| Description: | Enzyme Immunoassay | Enzyme Immunoassay |
| Intended Use: | The detection of IgG | |
| antibodies against Toxoplasma | ||
| gondii in human serum. | The detection of IgG | |
| antibodies against Toxoplasma | ||
| gondii in human serum. | ||
| Antigen Strain | RH | RH |
| Solid Phase: | Plastic Microwell | Plastic Microwell |
| Number of Incubation Periods: | Three | Three |
| Sample Dilution: | 1:51 | 1:51 |
| Sample Volume: | 100 μl | 200 μl |
| Sample Incubation | ||
| Duration: | 30 minutes | 30 minutes |
| incubation Temperature: | Room temperature | Room temperature |
| Ezyme-labeled Conjugate: | ||
| Antibody | Goat anti-human IgG | Goat or Sheep anti-human IgG |
| Enzyme | Alkaline phosphatase | Alkaline phosphatase |
| Conjugate Volume: | 100 μl | 200 μl |
| Conjugate Incubation | ||
| Duration: | 30 minutes | 30 minutes |
| Substrate: | p-Nitrophenyl | |
| phosphate | p-Nitrophenyl | |
| phosphate | ||
| Subtrate Volume: | 100 μl | 200 μl |
| Substrate Incubation | ||
| Duration: | 30 minutes | 45 minutes |
| Stop Reagent: | 0.5 M Trisodium | |
| phosphate | 3 N Sodium | |
| Hydroxide |
2
Stop Reagent Volume:
100 ul
405 nm
50 ul
Aeadout:
Spectrophotometric
Spectrophotometric 405 nm
Summary of Clinical Testing:
One hundred and forty-three sera from normal blood donors were assayed for the presence of Toxoplasma IgG antibodies, using the SeraQuest™ Toxoplasma IgG test and the INCSTAR Toxoplasma IgG Clin-ELISA™ test. Of the one hundred and forty-three specimens tested, forty-one were positive, and ninety-six were negative, by both tests. Of the six remaining specimens, three were positive in The SeraQuest™ test and negative in the comparative test, one was positive in the SeraQuest™ test and equivocal in the comparative test, and two specimens were equivocal in the SeraQuest™ test and negative in the comparative test. Excluding the equivocal results, the sensitivity and specificity, of the SeraQuest™ test relative to the INCSTAR Toxoplasma IgG Clin-ELISA™ test, was 98.8 % to 100 % (95 % C.I.) and 93.6 % to 100 % (95 % C.I.), respectively. The overall agreement was 95.5 % to 100 % (95 % C.I.). These results are shown below in Table 1.
Table 1. Results of Comparative Testing of 143 Serum Specimens, Using the SeraQuest™ Toxoplasma IgG Test and the INCSTAR Toxoplasma IgG Clin-ELISA™ Test.
| INCSTAR
| Toxoplasma IgG | SeraQuest Toxoplasma IgG | |||
|---|---|---|---|---|
| Positive | Equivocal | Negative | 95 % Confidence Interval* | |
| Positive | 41 | 0 | 0 | Relative sensitivity√ 98.8 to 100 |
| Equivocal | 1 | 0 | 0 | |
| Negative | 2 | 3 | 96 | Relative specificity√ 93.6 to 100 |
| Overall agreement√ 95.5 to 100 |
Excluding equivocal results.
Calculated by the normal method.