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.

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

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modified immunoassay, the ADVIA Centaur® Toxoplasma IgG (Toxo G) Assay. The purpose of the submission is to demonstrate substantial equivalence to a predicate device, not to present a new study with specific acceptance criteria and performance metrics for regulatory approval of a novel device.

Therefore, the document does not contain the information requested in points 1-7, and 9 about acceptance criteria, device performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance, nor does it specify details for the training set (point 8 and 9).

The core of this submission is to show that the modified device is substantially equivalent to the predicate device, meaning its safety and effectiveness are not adversely impacted by minor changes in reagent composition.

Here's what can be extracted from the provided text relevant to the request, focusing on the comparison between the modified and predicate device:

1. A table of acceptance criteria and the reported device performance:

The document does not specify formal acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity thresholds) for the modified device against a ground truth. Instead, the "acceptance" is based on demonstrating that the performance claims are unchanged compared to the predicate device, despite the modifications.

Feature	Predicate (Unmodified) ToxoG Assay (K012183)	Modified ToxoG Assay	Reported Performance (Claim)
Intended Use	See Section 5	Same - See Section 6	Unchanged
Sample Type	Serum, Heparinized Plasma, EDTA Plasma	Serum, Heparinized Plasma, EDTA Plasma	Unchanged
Sample Volume	10 µL	10 µL	Unchanged
Assay Range	0.5-700 IU/mL	0.5-700 IU/mL	Unchanged
Performance Claims	See Instructions for Use	Unchanged	"Unchanged" indicating equivalence to predicate device

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not detail specific sample sizes for a "test set" in the context of a new efficacy study. It only mentions "performance testing, and verification and validation activities" were conducted to demonstrate substantial equivalence, but without providing details on these studies, their sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This type of information is generally found in studies establishing the diagnostic accuracy of a new device against a clinical reference standard, not in a 510(k) submission for a modified device seeking substantial equivalence based on unchanged performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for the same reasons as point 3.

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:

Not applicable. This is an immunoassay and does not involve human readers interpreting results in the way an AI-assisted diagnostic imaging device would.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This phrase is typically used for AI/algorithm-driven diagnostics. This is an in vitro diagnostic immunoassay. While its performance is "standalone" in the sense of the instrument reading and quantifying results, the concept of a "human-in-the-loop" performance as distinct from "standalone" is not applicable here. The device itself performs the measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The document does not specify a "ground truth" in the context of a new diagnostic accuracy study. For initial approval of the predicate device, a ground truth for Toxoplasma IgG (e.g., highly characterized clinical samples, possibly confirmed by other reference methods or clinical diagnosis) would have been used. For this 510(k) of a modified device, the "ground truth" for demonstrating substantial equivalence is effectively the performance of the predicate device.

8. The sample size for the training set:

Not applicable. This is an immunoassay, not a machine learning or AI-driven device that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established:
Not applicable for the same reason as point 8.

Summary

{0}------------------------------------------------

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 AvenueTarrytown, NY 10591-5097
Contact Person:	Matthew GeeSenior 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

{1}------------------------------------------------

5. Intended Use of Predicate (Unmodified) Device

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.

{2}------------------------------------------------

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)	ModifiedToxoG Assay
Intended Use	See Section 5	Same - See Section 6
Sample Type	Serum, Heparinized Plasma,EDTA Plasma	Serum, Heparinized Plasma, EDTAPlasma
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

{3}------------------------------------------------

510(k) Summary of Safety and Effectiveness

Feature	Predicate (Unmodified)ToxoG Assay (K012183)	ModifiedToxoG Assay
Lite Reagent Conjugatep30 Ag Concentration	1.5 µg/mL	0.75 µg/mL
Lite Reagent ConjugateLoading Ratio	30:1	18:1
Lite Reagent AntibodyFormat	Whole IgG	F(ab)2 Fragment recognizing sameepitope as current assay
Mouse IgG Concentration	Lite Reagent Buffer800 mg/L	Lite Reagent Buffer400 mg/L
	Solid Phase Buffernone	Solid Phase Buffer400 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.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a bird or other winged creature, with its head facing left and its wings spread upward.

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

{5}------------------------------------------------

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

Image /page/5/Picture/9 description: The image shows a black and white map of a chain of islands. The islands are small and scattered, stretching diagonally across the frame from the upper left to the lower right. The islands are surrounded by white space, suggesting they are in the ocean.

{6}------------------------------------------------

Indications for Use

510(k) Number (if known):

K102681

Device Name:

ADVIA Centaur® Toxoplasma IgG (Toxo G) Assay

Indications For Use:

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 ____________________________________________________________________________________________________________________________________________________________________

11 .

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102681

Regulation Number and Section

§ 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).