The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum, using the Access Immunoassay Systems. The Access Toxo IgG assay aids in the diagnosis of Toxoplasma gondii infection and in the determination of protective levels of antibodies in pregnant women.

Device Description

The Access Toxo IgG reagents consist of reagent packs, calibrators, QC, substrate and wash buffer.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

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

The provided text does not explicitly state numerical acceptance criteria for the studies. Instead, it makes a general statement about the device meeting established criteria.

Acceptance Criteria	Reported Device Performance
Reproducibility	Met established acceptance criteria
Concordance	Demonstrated acceptable concordance
Linearity	Demonstrated acceptable linearity
Correlation (DxI vs. Access 2)	Demonstrated good correlation

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the test set. It mentions "concordance study data" for the method comparison, implying a test set was used, but the size is not specified. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The study focuses on comparing two instrument platforms for an immunoassay, not on establishing a ground truth for diagnostic accuracy based on expert review.

4. Adjudication method for the test set

This information is not applicable and not provided. The study is a comparison between two laboratory instrument platforms, not an assessment requiring expert adjudication of cases.

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

An MRMC comparative effectiveness study was not done. This study is about the performance of an immunoassay on a new instrument platform, not about AI assistance for human readers.

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

This concept is not directly applicable. The "device" in question is an immunoassay system (hardware and reagents), not a standalone algorithm. The study assesses the performance of this system as a whole. Its performance is inherently "standalone" in the sense that the instrument processes the samples and delivers results without human interpretation within the assay measurement, but it's not an algorithm in the typical AI sense.

7. The type of ground truth used

The concept of "ground truth" as it typically applies to diagnostic accuracy (e.g., pathology, outcomes data) is not directly relevant here. The study aims to demonstrate substantial equivalence between two instrument platforms using the same assay. The "ground truth" for the comparison would be the results generated by the already cleared "Access 2" System, which the new "DxI 800" System is being compared against.

8. The sample size for the training set

This information is not provided because an AI/machine learning training set is not applicable to an immunoassay instrument and reagent system. This is a traditional laboratory diagnostic device.

9. How the ground truth for the training set was established

This information is not provided and is not applicable, as there is no "training set" in the context of this immunoassay system.

Summary

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1.4 510(K) Summary

(Page 1 of 2)

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number K032162

Date Prepared: July 11, 2003

Submitter	Contact Person
Beckman Coulter, Inc	Lynn Weist
1000 Lake Hazeltine Drive	Staff Regulatory Affairs Specialist
Chaska, MN 55318	Phone: 952-368-1271
	Fax: 952-368-7610

General Information

Proprietary Name	Access® Immunoassay System Toxo IgG Assay
Classification Name	Toxoplasma gondii serological reagents
Device Class	Class II
Legally Marketed (Unmodified)Device	Access Toxo IgG Assay for use on the Access ImmunoassaySystems (K951495, cleared 12/20/95)

Device Description

The Access Toxo IgG reagents consist of reagent packs, calibrators, QC, substrate and wash buffer.

Intended Use

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510(k) Summary

(Page 2 of 2)

Description of the Modification to the Legally Marketed Device

The modification to the Access Toxo IgG assay is to add a new instrument platform, the Beckman Coulter UniCel™ Dxl 800 Access® Immunoassay System, to the family of Access Immunoassay Systems. The Dxl System is a new model within the same model series of Access Immunoassay Systems manufactured and distributed by Beckman Coulter, Inc. The DxI System was cleared for marketing by FDA on January 28, 2003, (K023764).

The DxI uses the same Access Toxo IgG reagents, Calibrators and QC, packaged the same as for the Access 2 System. The formulations of the substrate and wash buffer used with the Access Toxo IgG assay are unchanged. There are no changes to the intended uses, technical specifications or final performance specifications and claims for the assay.

Supporting Data

In order to demonstrate that the Access Toxo IgG assay on the Dxl System is substantially equivalent to the Access Toxo IgG assay on the Access 2 System, reproducibility, concordance and linearity studies were conducted. The Access Toxo IgG assay met the established acceptance criteria for reproducibility and demonstrated acceptable concordance and linearity. A method comparison (linear regression) study completed using the concordance study data demonstrated good correlation between the DxI and Access 2 Systems.

Conclusion

The information provided in this submission supports a substantial equivalence determination, and therefore, 510(k) premarket notification clearance of the Access Toxo IgG Assay on the UniCel Dxl 800 Access Immunoassay System.

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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The symbol appears to be a stylized representation of a human figure or a bird in flight, composed of curved lines. The text around the perimeter is not clearly legible due to the image quality, but it seems to be arranged in a circular fashion, following the shape of the logo.

Public Health Service

AUG - 8 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lynn Weist Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084

Re: K032162

Trade/Device Name: Access Toxo IgG Assay for use on the Access® Immunoassay Systems Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma Gondii Serological Reagents Regulatory Class: Class II Product Code: LGD Dated: July 14, 2003 Received: July 15, 2003

Dear Ms. Weist:

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.

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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 1.3

510(k) Number (if known): K032162 PAGE 1 OF 1

Device Name: Access® Toxo IgG Assay for use on the Access® Immunoassay Systems

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ﻜ (per 21 CFR 801.109) OR

Over-the-Counter Use (Optional Format 1-2-96)

Sally Ann
Division Sign-Off 8/7/03

Office of In Vitro Diagnostic Device Evaluation and Safety

KB 3 21122 510(k)_

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).