ABBOTT ARCHITECT FREE T3 by ABBOTT LABORATORIES

The ARCHITECT™ Free Ts (FT2) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (free T3) in human serum and plasma. The ARCHITECT Free T3 assay is to be used as an aid in the assessment of thyroid status.

Device Description

ARCHITECT Free T, is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free T, in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Free T2 is calibrated with ARCHITECT Free T2 Calibrators. ARCHITECT Free T2 Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System.

AI/ML Overview

This 510(k) summary describes a traditional device equivalence study rather than an AI/ML-based device study. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
The criteria for acceptance are implicit: to demonstrate substantial equivalence to the predicate device (AxSYM® Free T3 assay) in terms of quantitative determination of free T3.	Least squares linear regression: correlation coefficient = 0.958, slope = 0.82, y-axis intercept = 0.94 pg/mL.
	Passing-Bablok linear regression: correlation coefficient = 0.958, slope = 1.05, y-axis intercept = 0.21 pg/mL.

Explanation of Acceptance Criteria: The document directly states that "Substantial equivalence has been demonstrated between the ARCHITECT Free T3 assay and the AxSYM® Free T3 assay." This implies that the statistical metrics (correlation, slope, intercept) were compared against a pre-defined range of acceptable values (often based on clinical relevance or previous regulatory approvals for similar devices) to determine if the new device performed similarly enough to the predicate. The specific thresholds for these metrics (e.g., minimum correlation coefficient, acceptable range for slope and intercept) are not explicitly stated in this summary but would have been part of the full submission.

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

Sample Size: 1101 specimens
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "human serum and plasma."

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

This is not applicable to this type of in vitro diagnostic device study. The "ground truth" for quantitative assays is typically established by the reference method (the predicate device in this case) and traceable standards, not by expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication is typically for subjective assessments (e.g., image interpretation), not for quantitative chemical assays.

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

No. This is an analytical performance study comparing two quantitative assays, not a diagnostic accuracy study involving human readers interpreting outputs.

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

Yes, in a sense. The study assesses the performance of the ARCHITECT Free T3 assay (the "device" being evaluated) in comparison to the AxSYM® Free T3 (the "predicate device"). Both are automated or semi-automated assays, and their output is a quantitative value, not subject to human interpretation in the same way an AI output would be. The study focuses purely on the analytical performance of the device itself.

7. The Type of Ground Truth Used

Predicate Device Comparison: The "ground truth" or reference for comparison was the AxSYM® Free T3 assay. This is a common approach for 510(k) submissions where a new device's performance is demonstrated to be substantially equivalent to an already legally marketed device with the same intended use.

8. The Sample Size for the Training Set

Not applicable. This is an analytical validation of an in vitro diagnostic device, not an AI/ML model that requires a training set.

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

Not applicable. (See point 8)

Summary

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K983439

510(k) Summary Abbott ARCHITECT™ Free T2 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™ Free T, constitutes data supporting a substantially equivalent determination.

ARCHITECT Free T, is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free T, in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Free T, is calibrated with ARCHITECT Free T2 Calibrators. ARCHITECT Free T2 Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System.

Substantial equivalence has been demonstrated between the ARCHITECT Free T, assay and the AxSYM® Free T, assay. The intended use of both assays is for the quantitative determination of free T, in human serum and plasma. Least squares linear regression analysis of an ARCHITECT Free T, vs. AxSYM Free T, comparison, using 1101 specimens, gave the following parameter estimates: correlation coefficient = 0.958. slope = 0.82 and y-axis intercept = 0.94 pg/mL. Passing-Bablok linear regression analysis of an ARCHITECT Free T, vs. AxSYM Free T, comparison, using 1101 specimens, gave the following parameter estimates: correlation coefficient = 0.958, slope = 1.05 and yaxis intercept = 0.21 pg/mL.

In conclusion, these data demonstrate that the ARCHITECT Free T, assay is as safe and effective as, and is substantially equivalent to, the AxSYM Free T, 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™ Free T3 510(k) September 1998

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

NOV 20 1998

Ms. April Veoukas, J.D. Senior Regulatory Specialist ADD Requaltory Affairs Abbott Laboratories 200 Abbott Park Road Abbott Park, Illinois 60064-3537 Re: K983439 Abbott ARCHITECT™ Free T3 Trade Name: Product Code: CDP Requlatory Class: II JIT II JJX I September 28, 1998 Dated: Received: September 29, 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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 reqistration, 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 Regulations, 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 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 requlatory 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.

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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 leqally 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, "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): K 98343

Abbott ARCHITECT™ Free T3 Device Name: _________________________________________________________________________________________________________________________________________________________________

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)
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Over-The-Counter Use(Optional Format 1-2-96)
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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K983439

Format 1-2-96)

Regulation Number and Section

§ 862.1710 Total triiodothyronine test system.

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