(229 days)
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No
The document describes a standard in vitro diagnostic immunoassay kit and its components. There is no mention of AI or ML in the intended use, device description, or performance summary.
No.
This device is an in vitro diagnostic immunoassay designed to detect antibodies, aiding in the assessment of a patient's immunological response rather than providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "in vitro diagnostic immunoassay intended for the quantitative and qualitative detection of IgG antibodies to the Toxoplasma gondii parasite". The presence of the term "in vitro diagnostic" directly indicates its function as a diagnostic device.
No
The device description clearly lists physical reagents and materials (ReadyPack, Lite Reagent, Solid Phase, Calibrators, Quality Control Material) which are hardware components of an in vitro diagnostic assay.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is an "in vitro diagnostic immunoassay."
- Sample Type: It is intended for use with "human serum or plasma," which are biological samples tested outside of the body.
- Purpose: The purpose is the "quantitative and qualitative detection of IgG antibodies to the Toxoplasma gondii parasite," which is a diagnostic measurement to aid in assessing a patient's immunological response.
- Device Description: The components listed are reagents and calibrators used in a laboratory setting to perform the diagnostic test.
N/A
Intended Use / Indications for Use
The ADVIA Centaur Toxoplasma IgG assay is an IgG antibody capture microparticle direct in vitro diagnostic immunoassay intended for the quantitative and qualitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum or plasma (EDTA, heparin) using the ADVIA Centaur systems. The measurement of Toxoplasma IgG may be used to aid in the assessment of a patient's immunological response from individuals including women of childbearing age. This assay may be utlized with an IgM Toxoplasma result to determine recent serological response to Toxoplasma.
Product codes
LGD
Device Description
The modified ADVIA Centaur Toxo G Assay is comprised of the following:
ADVIA Centaur Toxo G ReadyPack® Primary Reagent Pack, including:
ADVIA Centaur Toxo G Lite Reagent (10.0 mL/reagent pack)
purified T. gondii p30 antigen (~0.75 µg/mL) complexed with mouse antip30 monoclonal antibody (F(ab)2 fragment) labeled with acridinium ester in protein buffer with surfactant and preservatives
ADVIA Centaur Toxo G Solid Phase (25.0 mL/reagent pack)
mouse anti-human IgGE monoclonal antibody (~0.3 mg/mL) covalently coupled to paramagnetic particles in protein buffer with surfactant and preservatives
ADVIA Centaur Toxo G Calibrators (1.0 mL/vial)
processed defibrinated human plasma positive for toxoplasma IgG antibodies with preservatives
ADVIA Centaur Toxo G Quality Control Material (2.7 mL/vial)
processed defibrinated human plasma negative and positive for toxoplasma igG antibodies with preservatives
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
individuals including women of childbearing age
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of performance testing, and verification and validation activities demonstrate that the design modifications to the ADVIA Centaur Toxo G assay do not impact its safety or effectiveness and do not alter its performance claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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MAY - 4 2011 This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990.
The assigned 510(k) Number is: K102681
1. Manufacturer's Name, Address, Telephone, and Contact Person
| Manufacturer: | Siemens Healthcare Diagnostics Inc. |
|---|---|
| Address: | 511 Benedict Avenue |
| Tarrytown, NY 10591-5097 | |
| Contact Person: | Matthew Gee |
| Senior Regulatory Specialist | |
| Phone: | 914-524-2099 |
| Fax: | 924-524-2500 |
| Email: | matthew.gee@siemens.com |
2. Date Summary Prepared
June 11, 2010
3. Device Trade Name / Common Name / Classification Name
| Trade Name: | ADVIA Centaur® Toxoplasma IgG (Toxo G) Assay |
|---|---|
| Common Name: | Immunoassay, Toxoplasma Gondii IgG |
| Classification Name: | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| FDA Classification: | Class II (Special Controls) |
| Review Panel: | Microbiology |
| Product Code: | LGD |
| Regulation Number: | 866.3780 |
4. Predicate (Unmodified) Device
| Device Name: | ADVIA Centaur® Toxoplasma IgG (Toxo G) Assay |
|---|---|
| Manufacturer: | Siemens Healthcare Diagnostics Inc. |
| (previously Bayer Diagnostics Corp.) | |
| 510(k) Number: | K012183 |
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5. Intended Use of Predicate (Unmodified) Device
The ADVIA Centaur Toxoplasma IgG assay is an IgG antibody capture microparticle direct in vitro diagnostic immunoassay intended for the quantitative and qualitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum or plasma (EDTA, heparin) using the ADVIA Centaur systems. The measurement of Toxoplasma IgG may be used to aid in the assessment of a patient's immunological response from individuals including women of childbearing age. This assay may be utilized with an IgM Toxoplasma result to determine recent serological response to Toxoplasma.
WARNING: The use of the ADVIA Centaur Toxoplasma IgG assay to diagnose recent infection by testing acute and convalescent samples is not recommended. The calculated values for toxoplasma lgG in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the toxoplasma IgG assay used. Values obtained with different assay methods cannot be used interchangeably.
This assay has not been cleared or approved by the FDA for the screening of blood or plasma donors. Testing should not be performed as a screening procedure for the general population.
6. Intended Use of Modified Device
The ADVIA Centaur Toxoplasma IgG assay is an IgG antibody capture microparticle direct in vitro diagnostic immunoassay intended for the quantitative and qualitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum or plasma (EDTA, heparin) using the ADVIA Centaur systems. The measurement of Toxoplasma IgG may be used to aid in the assessment of a patient's immunological response from individuals including women of childbearing age. This assay may be utlized with an IgM Toxoplasma result to determine recent serological response to Toxoplasma.
WARNING: The use of the ADVIA Centaur Toxoplasma IgG assay to diagnose recent infection by testing acute and convalescent samples is not recommended. The calculated values for toxoplasma IgG in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the toxoplasma IgG assay used. Values obtained with different assay methods cannot be used interchangeably.
This assay has not been cleared or approved by the FDA for the screening of blood or plasma donors. Testing should not be performed as a screening procedure for the general population.
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7. Device Description
The modified ADVIA Centaur Toxo G Assay is comprised of the following:
ADVIA Centaur Toxo G ReadyPack® Primary Reagent Pack, including:
ADVIA Centaur Toxo G Lite Reagent (10.0 mL/reagent pack)
purified T. gondii p30 antigen (~0.75 µg/mL) complexed with mouse antip30 monoclonal antibody (F(ab)2 fragment) labeled with acridinium ester in protein buffer with surfactant and preservatives
ADVIA Centaur Toxo G Solid Phase (25.0 mL/reagent pack)
mouse anti-human IgGE monoclonal antibody (~0.3 mg/mL) covalently coupled to paramagnetic particles in protein buffer with surfactant and preservatives
ADVIA Centaur Toxo G Calibrators (1.0 mL/vial)
processed defibrinated human plasma positive for toxoplasma IgG antibodies with preservatives
ADVIA Centaur Toxo G Quality Control Material (2.7 mL/vial)
processed defibrinated human plasma negative and positive for toxoplasma igG antibodies with preservatives
8. Similarities and Differences between Predicate and Modified Devices
| Feature | Predicate (Unmodified)
ToxoG Assay (K012183) | Modified
ToxoG Assay |
|--------------------|-------------------------------------------------|-------------------------------------------|
| Intended Use | See Section 5 | Same - See Section 6 |
| Sample Type | Serum, Heparinized Plasma,
EDTA Plasma | Serum, Heparinized Plasma, EDTA
Plasma |
| Sample Volume | 10 UL | 10 µL |
| Assay Range | 0.5-700 IU/mL | 0.5-700 IU/mL |
| Performance Claims | See Instructions for Use | Unchanged |
Table 1. Similarities between Current and Modified ADVIA Centaur Toxo G Assays
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510(k) Summary of Safety and Effectiveness
| Feature | Predicate (Unmodified)
ToxoG Assay (K012183) | Modified
ToxoG Assay |
|------------------------------------------------|-------------------------------------------------|--------------------------------------------------------------|
| Lite Reagent Conjugate
p30 Ag Concentration | 1.5 µg/mL | 0.75 µg/mL |
| Lite Reagent Conjugate
Loading Ratio | 30:1 | 18:1 |
| Lite Reagent Antibody
Format | Whole IgG | F(ab)2 Fragment recognizing same
epitope as current assay |
| Mouse IgG Concentration | Lite Reagent Buffer
800 mg/L | Lite Reagent Buffer
400 mg/L |
| | Solid Phase Buffer
none | Solid Phase Buffer
400 mg/L |
| PEG8000 in Solid Phase | none | 20 g/L |
| Tween20 in Solid Phase | none | 5 g/L |
9. Substantial Equivalence
The modified ADVIA Centaur Toxo G assay has the same operating principles, assay performance characteristics and intended use as the predicate device.
The results of performance testing, and verification and validation activities demonstrate that the design modifications to the ADVIA Centaur Toxo G assay do not impact its safety or effectiveness and do not alter its performance claims. The modified assay is substantially equivalent to the currently-marketed predicate ADVIA Centaur Toxo G assay.
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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics Inc. c/o Mr. Matthew Gee Senior Regulatory Specialist 511 Benedict Avenue Tarrytown, NY 10591-5097
MAY - 4 2011
Re: K102681
Trade/Device Name: ADIVA Centaur® Toxoplasma IgG (Toxo G) Assay Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma gondii Serological Reagents Regulatory Class: Class II Product Code: LGD Dated: April 13, 2011 Received: April 14, 2011
Dear Mr. Gee
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
ff your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
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Page 2 - Mr. Matthew Gee
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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Sufety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
ADVIA Centaur® Toxoplasma IgG (Toxo G) Assay
Indications For Use:
The ADVIA Centaur Toxoplasma IgG assay is an IgG antibody capture microparticle direct in vitro diagnostic immunoassay intended for the quantitative and qualitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum or plasma (EDTA, heparin) using the ADVIA Centaur systems. The measurement of Toxoplasma IgG may be used to aid in the assessment of a patient's immunological response from individuals including women of childbearing age. This assay may be utilized with an IgM Toxoplasma result to determine recent serological response to Toxoplasma.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Fredda. Pade
Division Sign-Off
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102681