(315 days)
The Platelia® Toxo IgG TMB kit is an in-vitro diagnostic test kit for the qualitative and quantitative detection of anti-Toxoplasma gondii IgG in human serum or plasma (EDTA, Heparin, Citrate).
Note: The Platelia® Toxo IgG TMB assay has not been cleared/approved by the FDA for blood/plasma donor screening.
The Platelia® Toxo IgG TMB assay utilizes a solid-phase enzyme immunoassay technique referred to as an indirect ELISA. Diluted test samples are placed into the T. gondii antigen coated wells of the microplate. During incubation, T. gondii antibodies present in the test sample bind to the T. gondii antigen. After incubation, unbound antibodies and other serum proteins are removed by washing. The conjugate (peroxidase-labeled monoclonal antibody specific for human gamma chains) is added to the micropalte wells. During a second incubation, the labeled monoclonal antibody binds to the IgG antibody – T. gondii antigen complexes attached to the microplate wells. The unbound conjugate is removed by washing. The addition of peroxidase substrate and chromogen solutions initiates a color development reaction. The enzymatic reaction is stopped by addition of an acid. The optical density reading, obtained with a spectrophotometer set at 450nm, is proportional to the amount of T. gondii IgG antibody present in the test sample and is converted into IU/ml using a standard curve. Standard control sera are calibrated against the WHO standard (TOXM185).
This document describes the performance of the Bio-Rad Laboratories Platelia® Toxo IgG TMB assay, an in-vitro diagnostic test kit for the qualitative and quantitative detection of anti-Toxoplasma gondii IgG in human serum or plasma.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state pre-defined acceptance criteria with pass/fail thresholds. However, it provides performance data from comparison studies and CDC test panel results, which can be interpreted as demonstrating the device's acceptable performance against a predicate device and a characterized serum panel.
| Performance Metric | Reported Device Performance (Platelia® Toxo IgG TMB) | Implied Acceptance Criteria (based on predicate device) |
|---|---|---|
| Comparison Study (vs another commercial EIA) | ||
| Negative Agreement | 99.71% (339/340) (95% CI: 98.98% - 100.00%) | High negative agreement (implied near 100%) |
| Positive Agreement | 100.00% (149/149) (95% CI: 99.66% - 100.00%) | High positive agreement (implied near 100%) |
| Overall Agreement | 99.80% (488/489) (95% CI: 99.29% - 100.00%) | High overall agreement (implied near 100%) |
| CDC Test Panel Study | ||
| Agreement with Positive Specimens | 100% | 100% agreement expected for characterized panel |
| Agreement with Negative Specimens | 100% | 100% agreement expected for characterized panel |
2. Sample Size Used for the Test Set and Data Provenance:
- Comparison Studies:
- Prospective samples: 468
- Retrospective specimens (seroconversion panels): 35 from 11 seroconversion panels.
- Total Test Set Size: 503 samples (468 prospective + 35 retrospective).
- Data Provenance: Not explicitly stated for all samples. The "Expected Values" section mentions 503 fresh and frozen serum samples from pregnant women obtained during routine laboratory activities in Paris, France. It is highly probable that the prospective samples for the comparison study are these samples from Paris, France. The provenance of the retrospective seroconversion panels is not specified, but they are typically commercially available panels.
- CDC Test Panel:
- 70 positive and 30 negative samples.
- Data Provenance: Obtained from the CDC.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number of experts or their qualifications for establishing ground truth.
- For the comparison studies, the ground truth was established by another commercially available enzyme immunoassay (EIA), implying accepted diagnostic methods. No human experts are mentioned as directly establishing this ground truth for each case individually.
- For the CDC Test Panel, the samples were "masked, characterized serum panel." This implies that the CDC (Centers for Disease Control and Prevention) had previously characterized these samples, establishing their positive or negative status for Toxoplasma gondii IgG. While this characterization would have been performed by experts, their specific number and qualifications are not provided within this document.
4. Adjudication Method for the Test Set:
Not applicable. The ground truth for the comparison study was based on another commercial EIA, and the CDC panel was a pre-characterized panel. There is no mention of a human adjudication process for resolving discordant results during these evaluations. Discrepancies (e.g., 5 equivocal and 1 positive result in the negative category, 3 equivocal and 3 positive results in the equivocal category from the predicate in the "Platelia® Toxo IgG TMB vs OPD Correlation Table") were simply reported and then excluded from agreement calculations, rather than being subjected to a specific adjudication process described in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The studies described are focused on the device's performance characteristics (precision, comparison to another EIA, and agreement with a CDC panel) rather than assessing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone study was done. The document describes the performance of the Platelia® Toxo IgG TMB assay (an indirect ELISA, which is an automated or semi-automated laboratory device) as an algorithm-only without human-in-the-loop performance. The results are based on the device's output (optical density converted to IU/ml) compared against reference methods.
7. The Type of Ground Truth Used:
- Comparison Studies: The ground truth was based on the results of another commercially available enzyme immunoassay (EIA).
- CDC Test Panel: The ground truth was based on results from a masked, characterized serum panel obtained from the CDC, implying established reference methods used by the CDC.
- Precision Studies: The ground truth was based on known negative and positive samples, which are internally characterized for reproducibility assessment.
8. The Sample Size for the Training Set:
The document describes a diagnostic assay (ELISA kit) rather than a machine learning or AI-based device that typically requires a 'training set.' Therefore, the concept of a training set as understood in AI/ML is not applicable here. The device's calibration and internal validation would rely on standard laboratory procedures and reference materials, but not an "AI training set."
9. How the Ground Truth for the Training Set Was Established:
As explained above, the concept of a "training set" in the context of an ELISA kit is not directly applicable. The device's operational parameters would be established during its development and manufacturing using internal quality control and reference standards. The standard control sera used for calibration (mentioned as being calibrated against the WHO standard TOXM185) serve a similar function to establish a reference for quantitative measurements.
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SFP 3 0 2002
ATTACHMENT I 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K013839
| DATE: | September 10, 2002 |
|---|---|
| APPLICANT: | Bio-Rad3, Boulevard Raymond Poincaré92430 Marnes-la-Coquette, France |
| OFFICIAL CORRESPONDENT: | Sylvie Confida |
| TELEPHONE: | 33-1-47-95-6138 |
| FAX: | 33-1-47-95-6242 |
| PRODUCT TRADE NAME: | Bio-Rad Laboratories Platelia® Toxo IgG TMB |
| COMMON NAME: | Toxoplasma IgG Enzyme Immunoassay (EIA) |
| CLASSIFICATION NAME: | 21 CFR 866.3780, Enzyme Linked Immunoabsorbent Assay,Toxoplasma Gondii |
| PREDICATE DEVICE: | Bio-Rad Laboratories Platelia® Toxo IgG (K89497) |
DEVICE DESCRIPTION
The Platelia® Toxo IgG TMB assay utilizes a solid-phase enzyme immunoassay technique referred to as an indirect ELISA. Diluted test samples are placed into the T. gondii antigen coated wells of the microplate. During incubation, T. gondii antibodies present in the test sample bind to the T. gondii antigen. After incubation, unbound antibodies and other serum proteins are removed by washing. The conjugate (peroxidase-labeled monoclonal antibody specific for human gamma chains) is added to the micropalte wells. During a second incubation, the labeled monoclonal antibody binds to the IgG antibody – T. gondii antigen complexes attached to the microplate wells. The unbound conjugate is removed by washing. The addition of peroxidase substrate and chromogen solutions initiates a color development reaction. The enzymatic reaction is stopped by addition of an acid. The optical density reading, obtained with a spectrophotometer set at 450nm, is proportional to the amount of T. gondii IgG antibody present in the test sample and is converted into IU/ml using a standard curve. Standard control sera are calibrated against the WHO standard (TOXM185).
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INTENDED USE
The Platelia® Toxo IgG TMB kit is an in-vitro diagnostic test kit for the qualitative and quantitative detection of anti-Toxoplasma gondii IgG in human serum or plasma (EDTA, Heparin, Citrate).
Note: The Platelia® Toxo IgG TMB assay has not been cleared/approved by the FDA for blood/plasma donor screening.
TECHNOLOGICAL CHARACTERISTICS
The Platelia® Toxo IgG TMB kit is a modified version of the Platelia® Toxo IgG kit and remains similar in form and function. The following comparison table indicates significant similarities and differences between the kits:
| Characteristics | Platelia® Toxo IgG (Predicate) | Platelia® Toxo IgG TMB |
|---|---|---|
| Format and Test Method | 96-well microplate EIA,non-breakaway wells | 96-well microplate EIA,breakaway wells |
| Intended Use | Assay for the qualitative andquantitative detection of anti-Toxoplasma gondii IgG in humanserum | Assay for the qualitative andquantitative detection of anti-Toxoplasma gondii IgG in humanserum or plasma |
| Positive Calibrators | Pooled human serum, negativefor T. gondii , is used to dilute thepositive calibrators | A synthetic matrix consisting ofTris-NaCl buffer, BSA, glycerol,and colorant is used tomanufacture the negative controland to dilute the positive control. |
| Chromogen | o . phenylenediamine-2 HCL(OPD) tablets | Tetramethylbenzidine (TMB)solution |
| Wavelength | Dual wavelength reading at492 nm and 620 nm. | Dual wavelength reading at450 nm and 620 nm |
Comparison Table
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PERFORMANCE SUMMARY
A. Precision Studies
Inter-assay and intra-assay reproducibility were determined by assaying two T. gondir lgG negative samples and four T. gondii IgG positive samples in triplicate, on three different days at three laboratory sites.
| Site |
|---|
| ------ |
| Neg 1 | Neg 2 | Pos 1 | Pos 2 | Pos 3 | Pos 4 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OD | IU/ml | OD | IU/ml | OD | IU/ml | OD | IU/ml | OD | IU/ml | OD | IU/ml | |
| N= | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 |
| Mean= | 0.116 | N/A | 0.073 | N/A | 1.016 | 37.544 | 0.829 | 27.144 | 1.472 | 72.500 | 2.152 | 220.222 |
| Within Run(intra-assay) sd= | 0.011 | N/A | 0.005 | N/A | 0.069 | 3.871 | 0.026 | 1.375 | 0.061 | 12.670 | 0.061 | 12.936 |
| %CV= | 9.2% | N/A | 6.6% | N/A | 6.8% | 10.3% | 3.1% | 5.1% | 4.1% | 17.5% | 2.8% | 5.9% |
| Total(inter-assay) sd= | 0.009 | N/A | 0.004 | N/A | 0.060 | 3.216 | 0.021 | 1.229 | 0.053 | 10.454 | 0.060 | 13.070 |
| %CV= | 7.6% | N/A | 5.6% | N/A | 5.9% | 8.6% | 2.6% | 4.5% | 3.6% | 14.4% | 2.8% | 5.9% |
Site 2
| Neg 1 | Neg 2 | Pos 1 | Pos 2 | Pos 3 | Pos 4 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OD | IU/ml | OD | IU/ml | OD | IU/ml | OD | IU/ml | OD | IU/ml | OD | IU/ml | |
| N= | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 |
| Mean= | 0.134 | 0.083 | 0.955 | 30.522 | 0.728 | 17.733 | 1.438 | 74.489 | 2.059 | 229.378 | ||
| Within Run | ||||||||||||
| (intra-assay) sd= | 0.007 | 0.007 | 0.010 | 0.631 | 0.024 | 1.107 | 0.020 | 2.835 | 0.031 | 9.941 | ||
| %CV= | 4.9% | N/A | 9.0% | N/A | 1.1% | 2.1% | 3.3% | 6.2% | 1.4% | 3.8% | 1.5% | 4.3% |
| Total | ||||||||||||
| (inter-assay) sd= | 0.016 | 0.012 | 0.073 | 2.492 | 0.062 | 2.124 | 0.097 | 9.374 | 0.060 | 20.109 | ||
| %CV= | 11.7% | 14.8% | 7.7% | 8.2% | 8.5% | 12.0% | 6.8% | 12.6% | 2.9% | 8.8% |
Site 3
| Neg 1 | Neg 2 | Pos 1 | Pos 2 | Pos 3 | Pos 4 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OD | IU/ml | OD | IU/ml | OD | IU/ml | OD | IU/ml | OD | IU/ml | OD | IU/ml | |
| N= | 9 | 9 | 9 | 9 | 9 | 8 | 9 | 9 | 9 | 9 | 9 | 9 |
| Mean= | 0.231 | 0.135 | 1.324 | 49.875 | 0.968 | 32.000 | 1.614 | 99.889 | 2.560 | 240.000 | ||
| Within Run(intra-assay) sd= | 0.011 | 0.022 | 0.065 | 3.682 | 0.040 | 2.000 | 0.068 | 15.899 | 0.171 | 0.000 | ||
| %CV= | 4.7% | N/A | 16.1% | N/A | 4.9% | 7.4% | 4.1% | 6.3% | 4.2% | 15.9% | 6.7% | 0.0% |
| Total(inter-assay) sd= | 0.012 | 0.028 | 0.104 | 6.935 | 0.114 | 8.775 | 0.256 | 40.746 | 0.161 | 0.000 | ||
| %CV= | 5.3% | 21.1% | 7.8% | 13.9% | 11.8% | 27.4% | 15.9% | 40.8% | 6.3% | 0.0% |
N/A = Not applicable
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In addition, inter-assay and intra-assay reproducibility with plasma samples were determined by assaying three additional samples (one T. gondii IgG negative sample and two T. gondii IgG positive samples) in triplicate, on three different days, at one laboratory site.
| Serum | Neg 1 | Pos 1 | Pos 2 | |||
|---|---|---|---|---|---|---|
| OD | IU/ml | OD | IU/ml | OD | IU/ml | |
| N = | 9 | 9 | 9 | 9 | 9 | 9 |
| Mean = | 0.061 | 0.918 | 29.37 | 0.735 | 19.98 | |
| Within-Run | ||||||
| (intra-assay) sd = | 0.003 | 0.043 | 2.242 | 0.018 | 0.930 | |
| %CV = | 4.9% | N/A | 4.7% | 7.6% | 2.4% | 4.7% |
| Total | ||||||
| (inter-assay) sd = | 0.002 | 0.098 | 2.936 | 0.052 | 1.131 | |
| %CV = | 4.1% | 10.7% | 10.0% | 7.0% | 5.7% | |
| EDTA | Neg 1 | Pos 1 | Pos 2 | |||
| OD | IU/ml | OD | IU/ml | OD | IU/ml | |
| N = | 9 | 9 | 9 | 9 | 9 | 9 |
| Mean = | 0.047 | 0.909 | 28.83 | 0.672 | 16.73 | |
| Within-Run | ||||||
| (intra-assay) sd = | 0.003 | 0.050 | 2.555 | 0.041 | 2.197 | |
| %CV = | 6.7% | N/A | 5.5% | 8.9% | 6.1% | 13.1% |
| Total | ||||||
| (inter-assay) sd = | 0.004 | 0.099 | 3.017 | 0.049 | 1.839 | |
| %CV = | 8.1% | 10.9% | 10.5% | 7.3% | 11.0% | |
| Citrate | Neg 1 | Pos 1 | Pos 2 | |||
| OD | IU/ml | OD | IU/ml | OD | IU/ml | |
| N = | 9 | 9 | 9 | 9 | 9 | 9 |
| Mean = | 0.067 | 0.918 | 29.30 | 0.735 | 19.93 | |
| Within-Run | ||||||
| (intra-assay) sd = | 0.003 | 0.019 | 0.981 | 0.015 | 0.739 | |
| %CV = | 4.3% | N/A | 2.1% | 3.3% | 2.0% | 3.7% |
| Total | ||||||
| (inter-assay) sd = | 0.004 | 0.072 | 1.373 | 0.063 | 1.602 | |
| %CV = | 6.3% | 7.8% | 4.7% | 8.6% | 8.0% | |
| Heparin | Neg 1 | Pos 1 | Pos 2 | |||
| OD | IU/ml | OD | IU/ml | OD | IU/ml | |
| N = | 9 | 9 | 9 | 9 | 9 | 9 |
| Mean = | 0.060 | 0.910 | 28.89 | 0.714 | 18.91 | |
| Within-Run | ||||||
| (intra-assay) sd = | 0.010 | 0.015 | 0.805 | 0.037 | 1.877 | |
| %CV = | 16.7% | N/A | 1.7% | 2.8% | 5.1% | 9.9% |
| Total | ||||||
| (inter-assay) sd = | 0.008 | 0.095 | 2.651 | 0.050 | 1.596 |
N/A = Not applicable
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B. Comparison Studies
Performance of the Platelia® Toxo IgG TMB assay was evaluated against another commercially available enzyme immunoassay (EIA) by testing 468 prospective samples and 35 retrospective specimens from 11 seroconversion panels.
| N = 503 | TMB | |||
|---|---|---|---|---|
| Neg | Equivocal | Pos | ||
| O | Neg | 339 | 5 | 1 |
| P | Equivocal | 0 | 3 | 3 |
Platelia® Toxo IgG TMB vs OPD Correlation Table (combined results)
Excluding equivocal samples, the combined results of comparative and retrospective testing demonstrated the following :
Negative agreement : 99.71% (339/340). The 95% confidence interval6 is 98.98% - 100.00%.
Positive agreement : 100.00% (149/149). The 95% confidence interval40 is 99.66% - 100.00%.
Overall agreement : 99.80% (488/489). The 95% confidence interval16 is 99.29% - 100.00%.
C. Expected Values
| D
A total of 503 fresh and frozen serum samples obtained from pregnant women during routine laboratory activities in the area of Paris, France were tested with the Platelia® Toxo IgG TMB assay. The distribution of IU/ml values is shown in the following chart.
Image /page/4/Figure/11 description: The image is a bar graph titled "Platelia Toxo IgG TMB Expected Values". The x-axis is labeled "Titer (IU/ml)" and displays titer ranges, while the y-axis is labeled "Frequency". The bar graph shows the frequency of different titer ranges, with the highest frequency of 332 occurring in the <3 range.
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D. CDC Test Panel
The following information is from a serum panel obtained from the CDC and tested by Bio-Rad Laboratories. The results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This docs not imply an endorsement of the assay by the CDC.
The panel consists of 70 positive and 30 negative samples. The Platelia® Toxo IgG TMB assay demonstrated 100% agreement with the positive specimens and 100% agreement with the negative specimens.
Please Note: There should be no other statistical calculation or inferences drawn from the panel results.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road · Rockville MD 20850
SEP 3 0 2002
Mr. David Bhend Regulatory Affairs Associate Bio-Rad Laboratories Diagnostics Group 6565 18511 Avenue NE Redmond, WA 98052
Re: K013839
Trade/Device Name: Platelia® Toxo IgG TMB Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma gondii serological reagents Regulatory Class: Class II Product Code: LGD Dated: July 19, 2002 Received: July 23, 2002
Dear Mr. Bhend:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and i additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Bio-Rad Laboratories Platelia Toxoplasma IgG TMB EIA
ATTACHMENT G
510(k) Number (if known): K013839
Device Name: Platelia® Toxo IgG TMB
Indications for Use:
The Platelia® Toxo IgG TMB kit is an in-vitro diagnostic test kit for the qualitative and quantitative detection of anti-Toxoplasma gondii IgG in human serum or plasma (EDTA, Heparin, Citrate).
Note: The Platelia® Toxo IgG TMB assay has not been cleared/approved by the FDA for blood/plasma donor screening.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Professional Use:
OR
Prescription Use: (Per 21 CFR 801.109)
Over-The-Counter Use: (Optional Format 1-2-96)
Alfred Aubain
510(k) Number
§ 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).