The Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum and plasma, using the Access Immunoassay Systems. This device is intended to aid in the monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies.

Device Description

The Access® Thyroglobulin reagents consist of reagent packs, calibrators, substrate and wash buffer.

AI/ML Overview

The provided text describes a 510(k) summary for the Access® Thyroglobulin Reagents on the Access® Immunoassay Systems. The submission is for a modification to add a new instrument platform (Beckman Coulter UniCel™ DxI 800 Access® Immunoassay System) to the existing system. The core of the study is to demonstrate substantial equivalence between the new instrument platform and the previously cleared Access 2 system.

Here's an analysis of the acceptance criteria and study as requested:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Device Performance Report
Method Comparison	The Access Thyroglobulin assay met the established acceptance criteria for method comparison when tested on the DxI system compared to the Access 2 system.
Precision	The Access Thyroglobulin assay met the established acceptance criteria for precision when tested on the DxI system.
Analytical Sensitivity	The Access Thyroglobulin assay met the established acceptance criteria for analytical sensitivity when tested on the DxI system.

Note: The specific numerical values or ranges for "established acceptance criteria" are not provided in the summary. The document only states that the criteria were met.

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

The document states that "method comparison, precision and analytical sensitivity studies were conducted." However, it does not provide any details on the sample sizes used for these studies or the data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not applicable to this type of device and study. The device is an immunoassay for quantitative determination of a biomarker, not an imaging or diagnostic device requiring expert interpretation for ground truth. The ground truth for such assays would typically be defined by reference methods or established laboratory standards.

4. Adjudication method for the test set

This information is not applicable as the study design does not involve human readers or interpretations that would require adjudication.

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

This information is not applicable. This is a laboratory immunoassay device, not an AI-assisted diagnostic tool that involves human readers.

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

Yes, a standalone performance study was done. The "Supporting Data" section indicates that "method comparison, precision and analytical sensitivity studies were conducted" for the Access Thyroglobulin assay on the DxI system to demonstrate substantial equivalence to the Access 2 system. This refers to the analytical performance of the instrument and reagents as a standalone system.

7. The type of ground truth used

The document does not explicitly state the "type of ground truth" in terms of clinical outcomes or pathology. For an immunoassay seeking substantial equivalence for a new instrument platform, the "ground truth" or reference for comparison would typically be the performance of the legally marketed predicate device (Access® Thyroglobulin Reagents on the Access® Immunoassay Systems on the Access 2 system). The studies would aim to show that the new platform produces equivalent analytical results (method comparison, precision, analytical sensitivity) to the predicate.

8. The sample size for the training set

This information is not applicable. The device is an immunoassay system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a system involves calibration using specific calibrator materials mentioned in the device description.

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

This information is not applicable for the reasons stated in point 8. The "ground truth" for calibration would be established by the manufacturer based on certified reference materials or established laboratory standards for the calibrators.

Summary

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MAY - 2 2003

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 K03 1269

Date Prepared: April 16,2003

Submitter	Contact Person
Beckman Coulter, Inc	Lynn Weist
1000 Lake Hazeltine Drive	Staff Regulatory Affairs Specialist
Chaska, MN 55318	Phone: 952-368-1271
	Fax: 952-368-7710

General Information

Proprietary Name	Access® Thyroglobulin Reagents on the Access®Immunoassay Systems
Classification Name	Tumor Associated Antigen Immunological Test System
Device Class	Class II
Legally Marketed(Unmodified) Device	Access® Thyroglobulin Reagents on the Access®Immunoassay Systems (K002905, cleared 10/19/00)

Device Description

The Access® Thyroglobulin reagents consist of reagent packs, calibrators, 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 Thyroglobulin reagents is to add a new instrument platform, the Beckman Coulter UniCel" Dx1 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 Dxl System was cleared for marketing by FDA on January 28, 2003, (K023764).

The DxI uses the same Access Thyroglobulin reagents and calibrators, packaged the same as for the Access 2 System. The formulations of the substrate and wash buffer used with the Access Thyroglobulin 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 Thyroglobulin assay on the Dxl system is substantially equivalent to the Access Thyroglobulin assay on the Access 2 system. method comparison, precision and analytical sensitivity studies were conducted. The Access Thyroglobulin assay met the established acceptance criteria for method comparison, precision and analytical sensitivity.

Conclusion

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

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, Minnesota 55318-1084

MAY - 2 2003

Re: K031269 Trade/Device Name: Access® Thyroglobulin Reagents on the Access® Immunoassay Systems Regulation Number: 21 CFR § 866.6010 Regulation Name: Tumor associated antigen immunological test system Regulatory Class: II Product Code: MSW Dated: April 16, 2003 Received: April 22, 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, 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 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). 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.

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Page 2 –

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). 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) 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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510(k) Number (if known): K03 1269

PAGE 1 OF 1

Device Name: Access® Thyroglobulin Reagents 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(per 21 CFR 801.109)	OR	Over-the-Counter Use(Optional Format 1-2-96)
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	J.P.Reaves for J. Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number	K031269
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Confidential

Regulation Number and Section

§ 866.6010 Tumor-associated antigen immunological test system.

(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.