The Access Thyroglobulin Antibody II assay is a paramagnetic chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.

Device Description

The Access Thyroglobulin Antibody II reagents, Thyroglobulin Antibody II calibrators, and the Access Immunoassay analyzers comprise the Access lmmunoassay System for the quantitative determination of thyroglobulin antibody in human serum and plasma.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Access Thyroglobulin Antibody II for use on the Access Immunoassay Systems, as extracted from the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Summary of Studies" section, which describes the performance characteristics that were measured and deemed acceptable for demonstrating substantial equivalence. Exact numerical acceptance thresholds for each test (e.g., "imprecision must be less than X%") are not explicitly stated as distinct criteria, but the reported performance values are presented as evidence of meeting acceptable levels.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Method Comparison	Strong correlation with predicate device	New = m(predicate)1.0 ± 0.12, R² ≥ 0.92 (for 397 samples, range <0.9 to 2500 IU/mL)
Imprecision	Low imprecision across various concentrations	Within-run: 3.6 to 5.7 %CVBetween-run: 0.0 to 5.2 %CVTotal: 4.8 to 7.7 %CV (at 26.9 to 1889.6 IU/mL).Overall: < 10% CV for ≥ 15 IU/mL; < 1.5 IU/mL SD for < 15 IU/mL.
High-dose Hook Effect	No hook effect at high concentrations	No hook to 50,000 IU/mL
Linearity	Linear across the assay's measuring range	Linear across the range of the assay (0.0 to 2500 IU/mL)
Limit of Blank (LoB)	Lowest measurement with no analyte	0.9 IU/mL (n=221)
Limit of Detection (LoD)	Lowest detectable concentration (95% probability)	0.9 IU/mL
Analytical Specificity	No significant interference; 100% agreement for autoimmune samples	No significant interference from total protein, bilirubin, hemoglobin, or triglycerides. 100% total agreement with autoimmune disease state samples.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 397 samples were used for the method comparison study. The LoB study used 221 samples. The number of samples for other studies (imprecision, linearity, analytical specificity) is not explicitly stated, although "samples with autoimmune disease state" were "tested" for analytical specificity.
Data Provenance: Not explicitly stated (e.g., country of origin). The data is from a prospective study, as it involves running samples on both the new device and the predicate device for comparison and performance characterization.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This device is an in vitro diagnostic (IVD) immunoassay that measures an analyte (thyroglobulin antibody) directly. Therefore, there is no "ground truth" established by human experts in the way that would apply to image-based diagnostic AI. The "ground truth" for method comparison and performance comes inherently from the measurements of the predicate device and established analytical methods.

4. Adjudication Method for the Test Set

Not applicable, as the device is an immunoassay and does not involve human interpretation or adjudication for its raw output. The "comparison" is between the new device's quantitative output and the predicate device's quantitative output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

Not applicable. This device is an automated immunoassay system, not an AI-assisted diagnostic tool that aids human readers in interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are standalone performance evaluations of the device (immunoassay system), as it functions as an automated system producing quantitative results. There is no "human-in-the-loop" component for the actual measurement process.

7. The Type of Ground Truth Used

The "ground truth" used for comparison, particularly in the method comparison study, is the quantitative measurement provided by the predicate device (Access Thyroglobulin Antibody II, K062516). For other performance metrics (imprecision, linearity, LoB, LoD), the "ground truth" is derived from established analytical methods and reference materials (e.g., NIBSC Anti-Thyroglobulin Serum, Human First International Reference Preparation, WHO Coded 65/93 for standardization).

8. The Sample Size for the Training Set

Not applicable. This device is an immunoassay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such devices typically involves calibration using specific calibrators as described ("Utilizes a stored calibration curve").

9. How the Ground Truth for the Training Set Was Established

Not applicable. As described above, there isn't a "training set" in the AI/ML context. The calibration of the immunoassay system uses specific calibrators, and its standardization is based on NIBSC Anti-Thyroglobulin Serum, Human First International Reference Preparation, WHO Coded 65/93.

Summary

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K.112933

DEC 2 7 2011

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510(k) Summary Prepared December 14, 2011

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

Submitter's Name and Address

Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

Primary Contact: Geraldine Baglien (952) 368-7645 (952) 368-7610 (fax)

Valynda Machen Alternate Contact: (952) 368-1383 (952) 368-7610 (fax)

Device Name

Trade Name:	Access Thyroglobulin Antibody II for use on theAccess Immunoassay Systems
Common Name:	Thyroglobulin Antibody Enzyme Immunoassay
Classification Name:	Immunochemical, Thyroglobulin Autoantibody

Predicate Device

Access Thyroglobulin Antibody II (K062516) Manufactured by Beckman Coulter, Inc.

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Device Description

Intended Use

The Access Thyroglobulin Antibody II (TgAb II) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thryoglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.

Parameter	Access TgAb II	Predicate Access TgAb II
	(K112933)	(K062516)
Intended use	The Access ThyroglobulinAntibody II assay is aparamagnetic particle,chemiluminescent immunoassayfor the quantitative determinationof thyroglobulin antibody levelsin human serum and plasmausing the Access ImmunoassaySystems. The measurement ofthyroid autoantibodies may aid inthe diagnosis of Hashimoto'sdisease, nontoxic goiter, andGraves' disease.	The Access ThyroglobulinAntibody II assay is aparamagnetic particle,chemiluminescent immunoassayfor the quantitative determinationof thyroglobulin antibody levels inhuman serum and plasma usingthe Access ImmunoassaySystems. The measurement ofthyroid autoantibodies may aid inthe diagnosis of Hashimoto'sdisease, nontoxic goiter, andGraves' disease.
Analyte Measured	Thyroglobulin Antibody	Thyroglobulin Antibody
Standardization	NIBSC Anti-ThyroglobulinSerum, Human FirstInternational ReferencePreparation, WHO Coded 65/93	NIBSC Anti-Thyroglobulin Serum,Human First InternationalReference Preparation, WHOCoded 65/93
Technology	Sandwich immunoassay	Sandwich immunoassay
Format	Chemiluminescent	Chemiluminescent
Method	Automated	Automated
Calibration	Utilizes a stored calibrationcurve	Utilizes a stored calibration curve
Sample Type	Serum or plasma	Serum or plasma
Measuring Range	0.9 - 2500 IU/mL	0.9 - 2500 IU/mL

Comparison of Technological Characteristics

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Summary of Studies

Method Comparison: A comparison of thyroglobulin antibody values from 397 samples, ranging from approximately <0.9 to 2500 IU/mL, was run with both the Access Thyroglobulin Antibody II immunoassay and the predicate Access Thyroglobulin Antibody II immunoassay. The new method (y-axis) was correrlated with the predicate (x-axis) using Passing-Bablock analysis, the following relationship was observed: new = m(predicate)1.0 ± 0.12, R² ≥ 0.92.

Imprecision: Within run imprecision ranged from 3.6 to 5.7 %CV, between run imprecision ranged from 0.0 to 5.2 %CV, and total imprecision ranged from 4.8 to 7.7 %CV at levels between 26.9 and 1889.6 IU/mL. The assay exhibits total imprecision of less than 10% CV for concentrations greater than or equal to 15 IU/mL and < 1.5 IU/mL SD at concentrations < 15 IU/mL.

High-dose Hook Effect: The Access Thyroglobulin Antibody II assay demonstrated no hook to 50,000 IU/mL.

Linearity: The Thyroglobulin Antibody II assay has demonstrated to be linear across the range of the assay (0.0 to 2500IU/mL).

Limit of Blank (LoB): The highest measurement result observed with no analyte present in a sample is 0.9 IU/mL (n=221).

Limit of Detection (LoD): The lowest concentration of analyte in a sample that can be detected with a stated probability (95%) is 0.9 IU/mL.

Analytical Specificity: There is no significant interference from total protein, bilirubin, hemoglobin, or trigycerides. Additionally, samples with autoimmune disease state were tested and showed 100% total agreement.

Conclusion:

The Access Thyroglobulin Antibody II assay, for use on the Access Immunoassay Systems, is substantially equivalent to the predicate device, Access Thyroglobulin Antibody II assay (K062516) for the measurement of thyroglobulin antibody.

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Beckman Coulter, Inc. Immunodiagnostic Development Center c/o Ms. Geraldine L. Baglien Senior Regulatory Affairs Specialist 1000 Lake Hazeltine Dr. Chaska, MN 55318-1084

DEC 2 7 2011

Re: K112933

Trade/Device Name: Access Thyroglobulin Antibody II Assay Regulation Number: 21 CFR §866.5870 Regulation Name: Thyroid Autoantibody immunological test system Regulatory Class: Class II Product Code: JNL, JIT Dated: December 14, 2011 Received: December 15, 2011

Dear Ms. Baglien:

We have reviewed your Section 510(k) premarket notification of intent to market the idevice we nave levice your Socioli 310(s) personalially equivalent (for the indications ferenced above and nave determined in marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device American Continents, or to commerce prior to May 20, 1970, the enability with the provisions of the Federal Food, Drug, devices that have been reculired in acceracy in of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applica and Cosment Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, merelore, market the device, soloject to the more of registration, listing of general controls provisions of the 110 includes and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is Classified (see above) into exas ff (-) } }) device can be found in Title 21, 2017 Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further Code of reasonal soncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled on a band on the requirements of the Act
that FDA has made a determination that your device complies with obecreains. . You must that FDA has made a decertimation that your and your let Federal agencies. You must or any Federal statutes and regulations administers by not limited to: registration and listing (21)
comply with all the Act's requirements, including, but not association (s comply with an the Act 31equirements) nones of the one of the reporting (reporting of

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Page 2 - Ms. Geraldine L. Baglien

medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related adverse overlity systems (OS) regulation (21 CFR Part 820). This letter requirences as bet form marketing your device as described in your Section 510(k) premarket win anow you to bogin market.ing of substantial equivalence of your device to a legally marketed nonication. The PDF Imaning of cassification 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 If you dosite specific and research in Vitro Diagnostic Device Evaluation and Safety 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 Tou may other other gearchers, 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 yours,

m Clar

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices 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): i(2933

Device Name: Access Thyroglobulin Antibody II Assay on the Access® Immunoassay Systems

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112933

Page 1 of j

Regulation Number and Section

§ 866.5870 Thyroid autoantibody immunological test system.

(a)
Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.(b)
Classification. Class II (performance standards).