(168 days)
Vidas TOXO IgG K922737
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No
The summary describes a standard immunoassay for detecting antibodies and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
The device is a diagnostic assay used to detect antibodies to Toxoplasma gondii, which aids in assessing a patient's serological response or recent infection, not to treat a condition.
Yes
The device is described as an "IgG antibody capture microparticle direct chemiluminometric immunoassay for the quantitative or qualitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum". Its stated use is "to aid in the assessment of a patient's serological response" and "may also be utilized with an IgM Toxoplasma result to determine recent serological response to Toxoplasma." This clearly indicates its role in diagnosing a patient's serological status related to Toxoplasma gondii infection.
No
The device is a chemiluminometric immunoassay that utilizes paramagnetic particles and acridinium ester, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay is for the "quantitative or qualitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum" and is used to "aid in the assessment of a patient's serological response". This indicates it is used to test human specimens to provide information about a person's health status.
- Device Description: The description details the biological target (Toxoplasma gondii antibodies), the type of assay (immunoassay), and how it works to detect these antibodies in a sample.
- Performance Studies: The document describes performance studies conducted using human serum samples to evaluate the assay's accuracy (sensitivity, specificity, agreement) compared to other commercially available tests and a CDC panel.
- Predicate Device: A predicate device (K922737 Vidas TOXO IgG) is listed, which is a common requirement for IVD submissions to regulatory bodies like the FDA.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADVIA Centaur Toxoplasma IgG assay is an IgG antibody capture microparticle direct chemiluminometric immunoassay for the quantitative or qualitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum qualitative EDTA, heparin) using the ADVIA Centaur System. The measurement of Toxoplasma IgG may be used to aid in the assessment of a patient's serological response from individuals including women of childbearing age. This assay may also be utilized with an IgM Toxoplasma result to determine recent serological response to Toxoplasma..
Testing should not be performed as a screening procedure for the general population.
This assay has not been cleared or approved by the FDA for the screening of blood or plasma donors.
Product codes (comma separated list FDA assigned to the subject device)
LGD
Device Description
Toxoplasma gondii is an intracellular parasitic protozoan that affects birds and mammals, with cats being the primary host. Infection is typically spread by eating raw or undercooked meat containing cysts or by coming in contact with oocyst-infected cat feces. Climate, dietary customs, and presence of cats influence the prevalence of T. gondii, which can vary considerably by geographical location and age. In healthy immunocompetent individuals, infections are usually asymptomatic or subclinical. If toxoplasmosis is diagnosed during the early stages of infection, the disease can be treated effectively with antibiotic therapy.
Mentions image processing
Not Found
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
Test Set:
1804 samples were tested at three U.S. sites. Samples were fresh and frozen, obtained from the mid-Atlantic and Midwest regions of the United States. The samples included: prenatal (N = 494), asymptomatic blood donors (N = 418), asymptomatic hospital patients (N = 806), and 86 patients with confirmed toxoplasma IgG positive status.
Annotation Protocol: The ADVIA Centaur results were compared to test results generated on a commercially available, automated toxoplasma IgG EIA. Discordant results (32 specimens) were further evaluated using other commercially available tests for toxoplasma IgG. For further analysis of 32 discordant specimens, consensus testing was performed using another commercially available test for toxoplasma IgG.
A characterized CDC Toxoplasma 1998 Human Serum Panel was also tested:
Sample Size: 70 positive specimens and 30 negative specimens.
Data Source: Centers for Disease Control (CDC).
Annotation Protocol: Positives and negatives were defined by the Dye Test. Results were submitted to the CDC for their interpretation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Relative Sensitivity and Specificity Study
Sample Size: 1804 samples
Key Results:
Relative Sensitivity: 96.5% (363/376), 95% CI (Confidence Interval) = 94.16 - 98.15
Relative Specificity: 98.6% (1370/1389), 95% CI = 97.9 - 99.2
Relative Agreement: 98.2% (1733/1765), 95% CI = 97.5 - 98.8
Study Type: Evaluation of Potentially Interfering Agents
Sample Size: 128 viral antibodies and disease state specimens.
Key Results:
The ADVIA Centaur Toxoplasma G assay was evaluated for potential cross reactivity/interference with 128 viral antibodies and disease state specimens. The negative toxoplasma IgG status of the specimens was verified using alternative EIAs. Results are presented in a table showing negative, equivocal, and positive outcomes for various disease states (e.g., Anti-Mitochondrial Antibodies, Anti-Nuclear Antibodies, Epstein Barr Virus, etc.). Some samples showed equivocal or positive results for toxoplasma IgG despite being negative in alternative EIAs for toxoplasma IgG.
Study Type: Precision Study (Reproducibility)
Sample Size:
- 5-member panel: 80 assays (2 times in 2 separate daily runs over 20 days) using one reagent lot and a stored calibration curve.
- 6-member panel: 210 assays for controls (210) and 120 assays for panel members (120) (assayed three times in each of 40 runs) with 3 reagent lots, 5 instruments, and 3 sites over multiple days.
Key Results: - 5-member panel: Within-run CVs ranged from 1.3% to 5.2% (for positive control and panel members). Total CVs ranged from 3.3% to 7.3%.
- 6-member panel: Within-run CVs ranged from 1.86% to 6.33% (for positive control and panel members). Total CVs ranged from 2.27% to 6.37%.
Study Type: Standardization Study
Key Results: The ADVIA Centaur Toxoplasma G assay is standardized against the World Health Organization (WHO) 3rd International Standard for anti-Toxoplasma Immunoglobulin in human serum. Several dilutions of the WHO standard were evaluated against the calibrators, showing a representative correlation with slope, y-intercept, correlation coefficient, and 95% confidence intervals.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity: 96.5%
Relative Specificity: 98.6%
Relative Agreement: 98.2%
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.
Vidas TOXO IgG K922737
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Bayer Diagnostics ADVIA Centaur Toxoplamsa IgG-Premarket Notification
Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitters Information
07/10/01
DEC 2 7 2001
| Contact person: | Barbara Preisel-Simmons PhD
Principal Scientist, QA |
|-----------------|-----------------------------------------------------------------------------|
| Address: | Bayer Diagnostics Corporation
333 Coney Street
East Walpole, MA 02032 |
| Phone:
Fax | (508) 660-4156
(508) 660-4899
Barbara.Peisel-Simmons.b@bayer.com |
Date Summary Prepared: March 2, 2001
Device Information 2.
| Proprietary Name: | Bayer Diagnostics ADVIA Centaur Toxoplasma IgG |
|---|---|
| Common Name: | Immunoassay, Toxoplasma Gondii |
| Device Classification: | Class II |
| 21 CFR 866.3780 |
3. Predicate Device Information
| Name: | Vidas TOXO IgG K922737 |
|---|---|
| Manufacturer: | bioMerieux |
4. Device Description
Toxoplasma gondii is an intracellular parasitic protozoan that affects birds and mammals, with cats being the primary host. Infection is typically spread by eating raw or undercooked meat containing cysts or by coming in contact with oocyst-infected cat feces. Climate, dietary customs, and presence of cats influence the prevalence of T. gondii, which can vary considerably by geographical location and age. In healthy immunocompetent individuals, infections are usually asymptomatic or subclinical. If toxoplasmosis is diagnosed during the early stages of infection, the disease can be treated effectively with antibiotic therapy.
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In pregnant women, T. gondii infection poses a potential threat to the fetus. The risk of a pregnant woman passing infection to the fetus is approximately 25% in the first trimester and increases to approximately 65% in the third trimester. The earlier in the pregnancy that the mother is infected the greater the potential severity of congenital toxoplasmosis. If the fetus becomes infected, the infant may have symptoms such as lymphadenopathy, chorioretinitis, microcephaly and cerebral calcifications. In immunosuppressed populations, such as cancer patients undergoing chemotherapy, transplants recipients, and AIDS patients, T. gondii has emerged as an important opportunistic pathogen leading to severe or fatal infections. The immunosuppressed state of these patients is thought to allow reactivation of a latent infection, and these patients may present symptoms such as headaches, confusion, fever, and focal neurological deficits.
Use of toxoplasma IgG assays has been shown to be a reliable method for establishing immune status and evaluating susceptibility to T. gondii infection. The presence of IgG antibodies that the individual has been infected with toxoplasma in the past, but the level of reactivity does not indicate how recently the infection occurred. In the majority of AIDS patients, the IgG response to primary T. gondii infection often lacks a significant rise in IgG titers.
5. Statement of Intended Use
The ADVIA Centaur Toxoplasma IgG assay is an IgG antibody capture microparticle direct chemiluminometric immunoassay for the quantitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum or plasma (EDTA, heparin) as an aid in the assessment of immune status to toxoplasma in individuals.
6. Summary of Technological Characteristics
The ADVIA Centaur Toxoplasma G assay is an immunoglobulin class-capture sandwich immunoassay using direct, chemiluminometric technology. The anti-human IgGFc monoclonal antibody is covalently coupled to paramagnetic particles in the Solid Phase. In the Lite Reagent, the purified T. gondii antigen is bound to an anti-p30 monoclonal labeled with acridinium ester. Antibody-antigen complexes will form if toxoplasma IgG is present in the sample.
A direct relationship exists between the amount of toxoplasma IgG activity present in the patient sample and the amount of relative light units (RLUs) detected by the system. A result of positive or negative is determined using a clinical cutoff value of 10 IU/mL.
7. Performance Characteristics
Expected Values
The prevalence of IgG antibody to T. gondii varies considerably by geographic location and the age of the patient. The following seroprevalence rates for various populations have been reported in the literature::
| Location | Seroprevalence Rate |
|---|---|
| Europe | |
| France, Italy | 50–85%, by region |
| Germany | 20–72%, by region |
| United Kingdom | 20% |
| Japan | 24% |
| Africa | 20–65%, by country |
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| S. America | 36-82%, by country |
|---|---|
| N. America | |
| and and the company of the began with the been and the comments of the comments of the comments of the comments of | |
| SAN STORES OF CHART SECTION OF CHART | 8-38%. by region |
In clinical trials, the seropositive rates for IgG antibody to T. gondii of samples obtained in the U.S. from pregnant women (N = 494) and low risk and healthy individuals (N = 1224) were 15.0% and 18.6%, respectively.
The distribution of ADVIA Centaur Toxoplasma G classifications observed in the clinical trials are summarized below:
| Population | N | Positive |
|---|---|---|
| Pregnant women | 494 | 74 (15.0%) |
| Random Hospital/Clinical patients | 1224 | 228 (18.6%) |
| Total | 1718 | 302 (17.6%) |
Sensitivity and Specificity
Relative Sensitivity and Specificity
The performance of the ADVIA Centaur Toxoplasma G assay was determined by testing a total of 1804 samples at three U.S. sites. The ADVIA Centaur results were compared to test results generated on a commercially available, automated toxoplasma IgG EIA. Fresh and frozen samples from the mid-Atlantic and Midwest regions of the United States were used. The samples included the following populations: prenatal (N = 494), asymptomatic blood donors (N = 418), asymptomatic hospital patients (N = 806), and 86 patients with confirmed toxoplasma IgG positive status. Of the 1804 specimens tested, 39 were equivocal by either the ADVIA Centaur or the predicate EIA. Discordant results were found on 32 specimens which were further evaluated using other commercially available tests for toxoplasma IgG.
Relative Sensitivity
Using the alternative method, 388 tested positive for toxoplasma IgG antibody. Of the specimens that tested positive, 12 were equivocal, 363 were positive, and 13 were negative using the ADVIA Centaur Toxoplasma G assay. The relative sensitivity was 96.5%.
Relative Specificity
Using the alternative method, 1400 tested negative for toxoplasma IgG antibody. Of the specimens that tested negative, 11 were equivocal, 19 were positive, and 1370 were negative using the ADVIA Centaur Toxoplasma G assay. The relative specificity was 98.6%.
NOTE: Samples giving equivocal results were not included in the calculation of relative sensitivity, relative specificity, and relative agreement.
| Site | N | Relative
Sensitivity (%) | Relative
Specificity (%) | Relative
Agreement (%) |
|-------|------|-----------------------------|-----------------------------|---------------------------|
| 1 | 804 | 99.5 (210/211) | 98.4 (568/577) | 98.7 (778/788) |
| 2 | 500 | 94.7 (89/94) | 97.7 (384/393) | 97.1 (473/487) |
| 3 | 500 | 90.1 (64/71) | 99.8 (418/419) | 98.4 (482/490) |
| Total | 1804 | 96.5 (363/376) | 98.6 (1370/1389) | 98.2 (1733/1765) |
Relative Sensitivity, Specificity, and Agreement Before Resolution of Discordant Samples
Relative refers to a direct comparison of ADVIA Centaur Toxoplasma G results to that of a similar assay. No attempt has been made to correlate with disease presence or absence, and no judgement can be made regarding the predicate assay's accuracy to predict toxoplasma disease.
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| Predicate Toxoplasma G EIA | Positive | Equivocal | Negative | Total | ||
|---|---|---|---|---|---|---|
| ADVIA | Positive | 363 | 6 | 19 | 388 | |
| Centaur | Equivocal | 12 | 1 | 11 | 24 | |
| Toxoplasma | Negative | 13 | 9 | 1370 | 1392 | |
| G | Total | 388 | 16 | 1400 | 1804 |
Realtive Sensitivity = 96.5% (363/376), 95% CI (Confidence Interval) = 94.16 - 98.15 Relative Specificity = 98.6% (1370/1389), 95% CI = 97.9 - 99.2 Relative Agreement = 98.2% (1733/1765), 95% CI = 97.5 - 98.8
Consensus Testing
Further analysis of the 32 specimens with discordant results was performed using another commercially available test for toxoplasma IgG. Upon retest in duplicate, two Centaur positive specimens were equivocal. Of the thirteen specimens that were negative by ADVIA Centaur and positive by EIA, three were equivocal and three were negative by consensus testing. Of the seventeen specimens that were positive by ADVIA Centaur and negative by EIA, six were equivocal and three were positive by consensus testing.
CDC Panel
A characterized CDC Toxoplasma 1998 Human Serum Panel was obtained from the Centers for Disease Control (CDC) and tested with the ADVIA Centaur Toxoplasma IgG assay. Testing was performed to provide additional information about the performance of the ADVIA Centaur Toxoplasma G assay with a masked characterized panel. Results were submitted to the CDC for their interpretation. This does not imply an endorsement of the assay by the CDC.
The panel consisted of 70 positive and 30 negative specimens as defined by the Dye Test. Of the 70 positives, ADVIA Centaur identified 68 as positive and 2 as equivocal. The two equivocal specimens were aliquots of the same sample. Of the 30 negatives, ADVIA Centaur identified 30 as negative. The ADVIA Centaur Toxoplasma G assay had 98% total agreement with the CDC results. Of the results obtained by the ADVIA Centaur Toxoplasma G assay, there was 97% agreement with the positive specimens and 100% agreement with the negative specimens.
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Evaluation of Potentially Interfering Agents
The ADVIA Centaur Toxoplasma G assay was evaluated for potential cross reactivity/interference with 128 viral antibodies and disease state specimens. The negative toxoplasma IgG status of the specimens was verified using alternative EIAs. The table outlines the results obtained on the ADVIA Centaur Toxoplasma G assay.
| Disease State | # of Samples | Sample | ADVIA Centaur Toxoplasma IgG Results | ||
|---|---|---|---|---|---|
| Type | Negative | Equivocal | Positive | ||
| Anti-Mitochondrial Antibodies (AMA) | 10 | Serum | 6 | 1 | 3 |
| Anti-Nuclear Antibodies (ANA) | 8 | Serum | 8 | 0 | 0 |
| Epstein Barr Virus (EBV) IgG | 5 | Serum | 5 | 0 | 0 |
| Flu Vaccine | 11 | Serum | 10 | 0 | 0 |
| Heterophilic/HAMA | 10 | Plasma | 10 | 0 | 0 |
| Herpes Simplex Virus (HSV) IgG | 10 | Serum | 10 | 0 | 0 |
| Measles (Rubeola) IgG | 14 | Serum | 14 | 0 | 0 |
| Multiple Myeloma (MM) IgG | 10 | Serum | 9 | 1 | 0 |
| Parvovirus B19 IgG | 10 | Serum & | |||
| Plasma | 10 | 0 | 0 | ||
| Rheumatoid Factor (RF) | 12 | Serum & | |||
| Plasma | 11 | 1 | 0 | ||
| Syphilis | 9 | Serum | 8 | 0 | 1 |
| Varicella Zoster (VZV) IgG | 11 | Serum | 10 | 1 | 0 |
| Cytomegalovirus (CMV) IgG | 8 | Serum & | |||
| Plasma | 8 | 0 | 0 |
Precision
Reproducibility of the ADVIA Centaur Toxoplasma G assay was determined as described in NCCLS protocol EP5-T2.12 A 5-member panel was assayed two times in two separate daily runs, over a period of 20 days (n = 80). The following results were obtained using one reagent lot and a stored calibration curve:
| Panel Member | N | Mean Concentration
(IU/mL) | Within-run
SD | Within-run
%CV | Total**
SD | Total**
%CV |
|------------------|----|-------------------------------|------------------|-------------------|---------------|----------------|
| Negative Control | 80 | 0.37 | 0.06 | NA* | 0.09 | NA |
| Positive Control | 80 | 27.54 | 0.89 | 3.2 | 0.98 | 3.6 |
| 1 | 80 | 1.67 | 0.09 | 5.2 | 0.12 | 7.3 |
| 2 | 80 | 8.22 | 0.14 | 1.7 | 0.33 | 4.0 |
| 3 | 80 | 20.00 | 0.27 | 1.3 | 0.65 | 3.3 |
- Not applicable.
** Includes within-run and run-to-run.
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System reproducibility was determined by testing a 6 member panel with 3 reagent lots including 5 instruments and 3 sites over multiple days. The panel was assayed three times in each of 40 runs. The following results were obtained:
| Panel
Member | N | Mean Concentration
(IU/mL) | Within-run | | Total** | |
|------------------|-----|-------------------------------|------------|------|---------|------|
| | | | SD | %CV | SD | %CV |
| Negative Control | 210 | 0.20 | 0.23 | NA* | 0.25 | NA |
| Positive Control | 210 | 29.91 | 0.61 | 2.05 | 0.75 | 2.51 |
| 1 | 120 | 18.32 | 0.44 | 2.42 | 0.53 | 2.91 |
| 2 | 120 | 45.02 | 0.84 | 1.86 | 1.12 | 2.50 |
| 3 | 120 | 50.57 | 0.96 | 1.89 | 1.15 | 2.27 |
| 4 | 120 | 123.71 | 7.84 | 6.33 | 7.88 | 6.37 |
- Not applicable.
** Includes within-run and run-to-run.
Standardization
The ADVIA Centaur Toxoplasma G assay is standardized against the World Health Organization (WHO) 3rd International Standard for anti-Toxoplasma Immunoglobulin in human serum. Several dilutions of the WHO standard were evaluated against the calibrators. A representative correlation is shown with slope, y-intercept, correlation coefficient and 95% confidence intervals.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Barbara Preisel-Simmons, Ph.D. Principal Scientist, Quality Assurance Bayer Corporation 63 North Street Medfield, MA 02052-1688
DEC 2 7 2001
K012183 Re: Trade/Device Name: Bayer Diagnostics, ADVIA Centaur Toxoplasma IgG Assay Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma gondii serological reagents Regulatory Class: Class II Product Code: LGD Dated: October 17, 2001 Received: October 30, 2001
Dear Dr. Preisel-Simmons:
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 1 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 Sutman
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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510(k) Number (if known) ___K012183
Device Name: ADVIA Centaur Toxoplasma IgG assay
Indications for Use: The ADVIA Centaur Toxoplasma IgG assay is an IgG antibody capture microparticle direct chemiluminometric immunoassay for the quantitative or qualitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum qualitative EDTA, heparin) using the ADVIA Centaur System. The measurement of Toxoplasma IgG may be used to aid in the assessment of a patient's serological response from individuals including women of childbearing age. This assay may also be utilized with an IgM Toxoplasma result to determine recent serological response to Toxoplasma..
Testing should not be performed as a screening procedure for the general population.
This assay has not been cleared or approved by the FDA for the screening of blood or plasma donors.
Woody Dubree
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number, K012183
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use (Optional Format 1-2-96)