ABBOTT ARCHITECT TOTAL T4 by ABBOTT LABORATORIES

The ARCHITECT™ Total T (TT ) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of thyroxine (total T.) in human serum and plasma. The ARCHITECT Total T assay is to be used as an aid in the assessment of thyroid status.

Device Description

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

AI/ML Overview

Here's an analysis of the provided text regarding the Abbott ARCHITECT™ Total T device, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Correlation Coefficient (Least Squares)	0.928
Slope (Least Squares)	1.01
Y-axis Intercept (Least Squares)	-0.11 ug/dL
Correlation Coefficient (Passing-Bablok)	0.928
Slope (Passing-Bablok)	0.99
Y-axis Intercept (Passing-Bablok)	-0.13 ug/dL

Note: The document only states the reported performance metrics. It does not explicitly define pre-specified acceptance criteria (e.g., "correlation coefficient > 0.95"). However, the statement "In conclusion, these data demonstrate that the ARCHITECT Total T2 assay is as safe and effective as, and is substantially equivalent to, the AxSYM Total Ta assay" implies that these performance metrics met the internal or regulatory standards for demonstrating substantial equivalence.

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

Sample Size: 1155 specimens
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective. Given the nature of a comparison study using existing specimens or collected for this purpose, it could be either, but retrospective analysis of banked samples is common for method comparisons.

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

This information is not provided in the document. The study is a method comparison between two assays, not a diagnostic accuracy study against a clinical ground truth established by experts. The "ground truth" in this context is the result from the predicate device (AxSYM® Total T. assay).

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication typically applies to studies where multiple experts independently review data and their interpretations are then reconciled. This study is an analytical comparison of an investigational device against a predicate device.

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 an analytical device comparison study, not an AI-assisted diagnostic study involving human readers.

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

This study is a standalone performance assessment of the ARCHITECT™ Total T device against a predicate device. There is no human-in-the-loop component mentioned; it is a direct comparison of the quantitative results from the two assays.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this study was the results obtained from the legally marketed predicate device, the AxSYM® Total T. assay. The new device's performance was compared directly to the predicate device's output on the same specimens.

8. The Sample Size for the Training Set

This information is not provided and is likely not relevant as this is an immunoassay device, not a machine learning or AI algorithm that typically requires a distinct training set. The device is "calibrated with ARCHITECT Total T, Calibrators," which serve a similar function in establishing the measurement curve, but this isn't typically referred to as a "training set" in the context of AI/ML.

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

This information is not provided and is not applicable in the same way it would be for an AI/ML device. The "ground truth" for calibration in an immunoassay refers to the assigned values of the calibrator materials, which are typically established through a rigorous process of reference methods and standardization.

Summary

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KC983440

510(k) Summary Abbott ARCHITECT™ Total Ta

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™ Total T, constitutes data supporting a substantially equivalent determination.

Substantial equivalence has been demonstrated between the ARCHITECT Total T. assay and the AxSYM® Total T. assay. The intended use of both assays is for the quantitative determination of total T. in human serum and plasma. Least squares linear regression analysis of an ARCHITECT Total T. vs. AxSYM Total T. comparison, using 1155 specimens, gave the following parameter estimates: correlation coefficient = 0.928. slope = 1.01 and y-axis intercept = - 0.11 ug/dL. Passing-Bablok linear regression analysis of an ARCHITECT Total T, vs. AxSYM Total T, comparison, using 1155 specimens, gave the following parameter estimates: correlation coefficient = 0.928, slope = 0.99 and yaxis intercept = - 0.13 ug/dL.

In conclusion, these data demonstrate that the ARCHITECT Total T2 assay is as safe and effective as, and is substantially equivalent to, the AxSYM Total Ta assay.

Prepared and Submitted September 28, 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™ Total T2 510(k) September 1998

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows a partial view of a document with a seal and some text. The seal on the left includes the words "DEPARTMENT OF HEALTH & HUMA". To the right of the seal, the text "NOV 25" is visible, suggesting a date or reference number. The document appears to be official, possibly from a government or health-related organization.

NOV 2 5 1998

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

Re: K983440 Trade Name: Abbott ARCHITECT™ Total T. Regulatory Class: II Product Code: KLI JIT II JJX I Dated: September 28, 1998 September 29, 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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 Register. 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 regulation (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, "Misbrandinq by reference to premarket notification"(21 CFR 807.97). Other qeneral 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): $98340

Abbott ARCHITECT™ Total T4 Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

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ical Laboratory Devices
510(k) Manager K983446

Regulation Number and Section

§ 862.1700 Total thyroxine test system.

(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.