ABBOTT ARCHITECT TSH by ABBOTT LABORATORIES

Abbott ARCHITECT™ TSH is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of thyroid stimulating hormone (TSH) in human serum and plasma. The ARCHITECT TSH assay is to be used as an aid in the assessment of thyroid status, diagnosis of thyroid disease, and treatment of thyroid disease.

Device Description

ARCHITECT TSH is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of TSH in human serum and plasma (lithium heparin, sodium heparin, or potassium EDTA). ARCHITECT TSH is calibrated with ARCHITECT TSH Calibrators. ARCHITECT TSH Controls are assayed to verify the accuracy and precision of the Abbott ARCHITECT i System.

AI/ML Overview

The provided text describes the Abbott ARCHITECT™ TSH device, an in vitro diagnostic assay, and its demonstration of substantial equivalence to a predicate device, the AxSYM® Ultrasensitive hTSH assay.

Here's an analysis of the provided information against your requested categories:

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

Acceptance Criteria (Implied)	Reported Device Performance
Correlation Coefficient (Linear Regression)	0.987 (for both Least Squares and Passing-Bablok)
Slope (Least Squares)	0.96 (95% CI: 0.95 to 0.98)
Y-intercept (Least Squares)	-0.7135 uIU/mL (95% CI: -1.1931 to -0.2339)
Slope (Passing-Bablok)	0.91 (95% CI: 0.90 to 0.92)
Y-intercept (Passing-Bablok)	0.0098 uIU/mL (95% CI: 0.0019 to 0.0162)

Note: The document implicitly defines acceptable performance through the reported metrics demonstrating substantial equivalence to the predicate device. Specific numerical "acceptance criteria" for these metrics are not explicitly stated, but the strong correlation and narrow confidence intervals indicate acceptable performance for substantial equivalence.

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

Sample Size: 534 specimens.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or 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 provided in the document. The "ground truth" for this type of assay comparison is typically derived from the predicate device's results.

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

Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments. For a quantitative immunoassay comparison, direct numerical comparison to a predicate device usually serves as the validation method. Therefore, an explicit adjudication method is not applicable/not mentioned.

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 is an in vitro diagnostic device (IVD) assay, not an AI-assisted diagnostic imaging or human-read interpretation system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not done.

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

Yes, this was a standalone performance study as it evaluated the performance of the ARCHITECT TSH assay (the "algorithm") directly against a predicate device, without human intervention in the result generation or comparison process beyond standard laboratory procedures.

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

The "ground truth" in this context is the results obtained from the legally marketed predicate device, the AxSYM® Ultrasensitive hTSH assay. The new device's performance is compared against the established performance of the predicate device to demonstrate substantial equivalence.

8. The sample size for the training set

This involves an in vitro diagnostic assay with a chemical reaction, not a machine learning algorithm that typically requires a distinct "training set." Therefore, the concept of a "training set" as understood in AI/ML is not applicable to this type of study. The 534 specimens likely represent the entire dataset used for demonstrating equivalence.

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

As a "training set" in the AI/ML sense is not applicable, the method for establishing its "ground truth" is also not applicable. For the overall study, the predicate device's results served as the reference standard.

Summary

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NOV 2 0 1998

K.983442

510(k) Summary Abbott ARCHITECT™ TSH Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

The following information as presented in the Premarket Notification [510(k)] for Abbott ARCHITECT™ TSH constitutes data supporting a substantially equivalent determination.

Substantial equivalence has been demonstrated between the ARCHITECT TSH and the AxSYM® Ultrasensitive hTSH assay. The intended use of both assays is for the quantitative determination of human thyroid stimulating hormone (TSH). Both assays can be performed with human serum and plasma (lithium heparin, sodium heparin, or potassium EDTA). The least squares linear regression analysis between these two assays. using 534 specimens, yielded a correlation coefficient of 0.987, slope of 0.96 (95% confidence interval of 0.95 to 0.98), and y-axis intercept of -0.7135 uIU/mL (95% confidence interval of -1.1931 to -0.2339). The Passing-Bablok linear regression analysis between these two assays, using 534 specimens, vielded a correlation coefficient of 0.987, slope of 0.91 (95% confidence interval of 0.90 to 0.92), and y-axis intercept of 0.0098 uIU/mL (95% confidence interval of 0.0019 to 0.0162).

In conclusion, these data demonstrate that the ARCHITECT TSH assay is as safe and effective as, and is substantially equivalent to the AxSYM Ultrasensitive hTSH II assay.

Prepared and Submitted September 29, 1998 by: April Veoukas, J.D. Senior Regulatory Specialist ADD Regulatory Affairs 847-937-8197

Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537

ARCHITECT TSH 5100% September 1998 TH 510K DOC

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NOV 20 1909

Ms. April Veoukas, J.D. Senior Requlatory Specialist ADD Requaltory Affairs Abbott Laboratories 200 Abbott Park Road Abbott Park, Illinois 60064-3537 Re: K983442

Trade Name: Abbott ARCHITECT™ TSH Requlatory Class: II Product Code: JLW JIT II JJX I Dated: September 29, 1998 September 30, 1998 Received:

Dear Ms. Veoukas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 199349

Device Name: Abbott ARCHITECT™ TSH

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K983442
Prescription Use ✓(Per 21 CFR 801.109)	OR Over-The-Counter Use ______
	(Optional Format 1-2-96)

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.