(168 days)
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.
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.
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.
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.
The provided text describes the performance characteristics of the Bayer Diagnostics ADVIA Centaur Toxoplasma IgG assay. The acceptance criteria are implicitly derived from the reported performance metrics, particularly "Relative Sensitivity and Specificity" and "CDC Panel" results.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as target values in the document. However, based on the provided results and the context of a 510(k) submission for substantial equivalence, the reported performance values are what the manufacturer submitted as demonstrating sufficient accuracy relative to a predicate device and a reference panel. The table below uses the "Total" values from the "Relative Sensitivity, Specificity, and Agreement Before Resolution of Discordant Samples" section and the "CDC Panel" results as key performance indicators.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Relative Sensitivity | High (e.g., above 90-95%) compared to predicate EIA | 96.5% (363/376) with 95% CI (94.16 - 98.15) |
| Relative Specificity | High (e.g., above 95-98%) compared to predicate EIA | 98.6% (1370/1389) with 95% CI (97.9 - 99.2) |
| Relative Agreement | High (e.g., above 95%) compared to predicate EIA | 98.2% (1733/1765) with 95% CI (97.5 - 98.8) |
| CDC Panel Agreement | High agreement with CDC's characterized panel (especially for positives and negatives) | Total: 98%, Positive: 97% (68/70), Negative: 100% (30/30) |
| Precision (Total %CV) | Low Variability across different concentrations (e.g., <10% for most clinical ranges) | Negative Control: NA, Positive Control: 3.6 - 2.51%, Panel 1: 7.3 - 2.91%, Panel 2: 4.0 - 2.50%, Panel 3: 3.3 - 2.27%, Panel 4: 6.37% |
| Interfering Agents | Low cross-reactivity/interference | Outlined in table: Some positive/equivocal results for AMA, MM, Syphilis, VZV. Most were negative. |
2. Sample size used for the test set and the data provenance
- Sample Size for Relative Performance: A total of 1804 samples were tested at three U.S. sites.
- Sub-populations: Prenatal (N = 494), Asymptomatic blood donors (N = 418), Asymptomatic hospital patients (N = 806), and 86 patients with confirmed toxoplasma IgG positive status.
- Data Provenance: Fresh and frozen samples from the mid-Atlantic and Midwest regions of the United States. The study is retrospective as it uses collected samples.
- Sample Size for CDC Panel: The CDC panel consisted of 100 specimens (70 positive and 30 negative).
- Sample Size for Interfering Agents: 128 viral antibodies and disease state specimens.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set.
- For the "Relative Sensitivity and Specificity" study, the ground truth was based on a commercially available, automated toxoplasma IgG EIA (predicate device). Discordant results were further evaluated using "other commercially available tests for toxoplasma IgG" (referred to as "Consensus Testing").
- For the "CDC Panel," the ground truth was established by the Centers for Disease Control (CDC), with specimens defined as positive or negative by the Dye Test.
4. Adjudication method for the test set
- For the "Relative Sensitivity and Specificity" study: Initially, the ADVIA Centaur results were compared to a predicate EIA. For discordant results (32 specimens), a form of adjudication was performed using "another commercially available test for toxoplasma IgG" (referred to as "Consensus Testing"). The exact method (e.g., sequential testing, resolution by a third test) is not explicitly detailed with a specific "2+1" or "3+1" notation, but it implies a process of resolving discrepancies using an additional reference method.
- For the "CDC Panel": The CDC's pre-characterized results based on the Dye Test served as the gold standard, so no further adjudication of the ADVIA Centaur results against this panel was performed by the study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for an in-vitro diagnostic device (immunoassay) and does not involve human readers interpreting images or data alongside an AI tool. Therefore, there is no effect size related to human reader improvement with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this entire study describes the standalone performance of the ADVIA Centaur Toxoplasma IgG assay (an immunoassay device). It operates without human interpretation in the loop beyond sample preparation and result collection. The assay directly provides a quantitative result (IU/mL) and a classification (positive, negative, equivocal) based on a clinical cutoff.
7. The type of ground truth used
- For the "Relative Sensitivity and Specificity" study: The primary ground truth was derived from results of a commercially available, automated toxoplasma IgG EIA (predicate device), supplemented by consensus testing using other commercial toxoplasma IgG tests for discordant samples. This is a form of expert consensus/reference method comparison.
- For the "CDC Panel": The ground truth was based on the Dye Test, which is a highly regarded reference method for Toxoplasma gondii antibody detection, and the panel was characterized by the CDC. This is essentially a gold standard/reference method ground truth.
- For the Interfering Agents study: The negative toxoplasma IgG status of the specimens was "verified using alternative EIAs." This also points to a reference method comparison.
8. The sample size for the training set
The document does not provide information on a training set sample size. This is typical for an immunoassay development and validation rather than a machine learning model. The device itself is an immunoassay, not an AI/ML algorithm that undergoes explicit "training" in the conventional sense. The "training" would be more akin to assay development, optimization, and establishment of calibration curves, which don't have a distinct "training set" in the same way an AI algorithm does.
9. How the ground truth for the training set was established
As there is no explicit "training set" for an AI/ML algorithm, the concept of establishing ground truth for it is not applicable here. The assay's performance characteristics (e.g., cutoff values, dynamic range) are established through analytical validation and clinical correlation studies, typically against established reference methods or clinically defined patient populations, rather than an AI-specific training process. The standardization against the WHO 3rd International Standard for anti-Toxoplasma Immunoglobulin in human serum is a key aspect of defining the assay's quantitative output.
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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 PhDPrincipal Scientist, QA |
|---|---|
| Address: | Bayer Diagnostics Corporation333 Coney StreetEast Walpole, MA 02032 |
| Phone:Fax | (508) 660-4156(508) 660-4899Barbara.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 II21 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. Americaand and the company of the began with the been and the comments of the comments of the comments of the comments ofSAN 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 | RelativeSensitivity (%) | RelativeSpecificity (%) | RelativeAgreement (%) |
|---|---|---|---|---|
| 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-runSD | 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:
| PanelMember | 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)
§ 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).