The Access HYPERsensitive hTSH assay provides in vitro quantitative measurement of human thyroid stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH assay is indicated for use with patients where an evaluation of their thyroid status is desired.

Device Description

The Access® HYPERsensitive hTSH assay consists of the reagent pack, calibrators, and diluent. Consumables required for the assay include substrate and wash buffers.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "Access HYPERsensitive hTSH assay." This submission focuses on demonstrating substantial equivalence to a previously cleared device, specifically by adding plasma as a sample type. The information provided is primarily related to the regulatory submission process and not a detailed clinical study demonstrating device performance against specific acceptance criteria in the context of AI/ML or complex diagnostic scenarios like image analysis.

However, I can extract the relevant information regarding the study that was conducted to demonstrate substantial equivalence, although it doesn't fit the typical structure of acceptance criteria for AI models.

Here's an analysis of the provided text based on your request, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance
Good correlation between plasma and serum samples for hTSH levels	Study results demonstrate good correlation between the plasma and serum samples.
Substantial equivalence to predicate device Access HYPERsensitive hTSH assay (K925637 and K954825)	The assay was deemed substantially equivalent by the FDA.
Same methodology as predicate	Yes, stated.
Same product type as predicate	Yes, stated.
Quantitative nature maintained	Yes, stated.
Same components as predicate	Yes, stated.

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

Sample Size for Test Set: The document states that a "method correlation study, using paired plasma and serum samples, was conducted," but it does not specify the sample size for this study.
Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It only mentions "human serum and plasma."

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

This type of information is not applicable or provided in this submission. This is a chemiluminescent immunoassay for quantitative determination of hTSH, not an AI/ML device relying on human expert interpretation for ground truth establishment. The "ground truth" would be the measured hTSH levels in the samples.

4. Adjudication Method for the Test Set

This information is not applicable or provided. Since it's a quantitative measurement assay, there wouldn't typically be an adjudication method in the way it's described for expert-based diagnoses.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI devices assisting human readers (e.g., radiologists interpreting images). This submission pertains to a standalone in vitro diagnostic assay.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no AI assistance is involved.

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

Yes, in a sense, the entire evaluation concerns the standalone performance of the assay device (the Access HYPERsensitive hTSH assay) in quantitatively measuring hTSH levels. There is no human-in-the-loop component for the measurement itself. The study specifically focused on the device's ability to produce consistent quantitative results across different sample types (serum vs. plasma).

7. The type of Ground Truth Used

The ground truth implicitly used for the correlation study would be the quantitative hTSH levels obtained from the Access HYPERsensitive hTSH assay itself, specifically comparing measurements in paired serum and plasma samples. It's a comparison of the device's own performance across different matrices, rather than against an external gold standard like pathology or outcome data in the context of a new diagnostic. The predicate device's performance on serum and plasma is also part of the established "ground truth" for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" as this is not an AI/ML device that requires machine learning training. The "supporting data" refers to the method correlation study performed for regulatory submission, not a machine learning training phase.

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

Not applicable, as there is no training set in the AI/ML context.

Summary of the Study for Substantial Equivalence:

The study conducted was a method correlation study designed to demonstrate that the expanded use of the "Access® HYPERsensitive hTSH assay" to include human plasma samples produces results substantially equivalent to its performance with human serum samples. The primary finding was that the study results showed "good correlation between the plasma and serum samples." This finding, along with the assay utilizing the same methodology, being the same product type, being quantitative, and sharing the same components as the previously cleared predicate device, supported the determination of substantial equivalence by the FDA. The specifics of the sample size, data provenance, and detailed statistical analyses were not provided in this 510(k) summary.

Summary

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510(k) Summary

[As required by 21 CFR 807.92]

510(k) Number K023093

Date Prepared:

Submitter	Contact Person
Beckman Coulter, IncDiagnostics Division1000 Lake Hazeltine DriveChaska, MN 55318	Denise ThompsonRegulatory Affairs SpecialistPhone: 952-368-1202Fax: 952-368-7610

General Information

Trade Name	Access® HYPERsensitive hTSH assay
Common Name	Thyroid stimulating hormone assay
Classification Name	Thyroid stimulating hormone test system (21 CFR 862.1690)

Device Description

The Access® HYPERsensitive hTSH assay consists of the reagent pack, calibrators, and diluent. Consumables required for the assay include substrate and wash buffers.

Intended Use

The Access HYPERsensitive hTSH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, hTSH) levels in human serum and plasma using the Access® Immunoassay Systems.

Substantial Equivalence Comparison

The Access HYPERsensitive hTSH assay is substantially equivalent to the previously cleared Access HYPERsensitive hTSH assay (K925637 and K954825). Both assays utilize the same methodology, are the same product type, and are quantitative. The subject and predicate assays include the same components. The only difference between the two assays is that the sample type has been expanded to include human plasma samples.

Supporting Data

To demonstrate substantial equivalence, a method correlation study, using paired plasma and serum samples, was conducted using the Access HYPERsensitive hTSH assay. Study results demonstrate good correlation between the plasma and serum samples.

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Conclusion

The information provided in this submission supports a substantial equivalence determination, and therefore 510(k) premarket notification clearance of the Access HYPERsensitive hTSH assay.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a way that suggests forward movement or progress.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Denise Thompson Regulatory Affairs Specialist Beckman Coulter, Inc. · 1000 Lake Hazeltine Drive Chaska, MN 55318-1084

Re: K023093

Trade/Device Name: Access® HYPERsensitive hTSH on the Access® Immunoassay Systems Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: Class II Product Code: JLW; JIS Dated: September 17, 2002 Received: September 18, 2002

Dear Ms. Thompson:

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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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 Butman

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: K023093

Device Name: Access® HYPERsensitive hTSH on the Access® Immunoassay Systems

Indications:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

510ck) Number ___

Prescription Use (Per 21 CFR 801.109)

Over-The-CounterUse

(Optional Format 1-2-96)

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(Division Sign-Off)
Division of Clinical Laboratory Devices

Regulation Number and Section

§ 862.1690 Thyroid stimulating hormone test system.

(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.