ABBOTT ARCHITECT TOTAL T3

K983434 · Abbott Laboratories · CDP · Nov 20, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983434
• Device Name: ABBOTT ARCHITECT TOTAL T3
• Applicant: Abbott Laboratories
• Product Code: CDP · Clinical Chemistry
• Decision Date: Nov 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1710
• Device Class: Class 2

Intended Use

The ARCHITECT™ Total T3 (TT) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total triiodothyronine (total T3) in human serum and plasma. The ARCHITECT Total T, assay is to be used as an aid in the assessment of thyroid status.

Device Story

The ARCHITECT Total T3 is a Chemiluminescent Microparticle Immunoassay (CMIA) designed for use on the Abbott ARCHITECT i System. It processes human serum and plasma samples (lithium heparin, sodium heparin, or potassium EDTA) to quantitatively measure total triiodothyronine (T3) levels. The system utilizes chemiluminescent technology to detect the analyte, providing results that assist clinicians in assessing a patient's thyroid status. The device is intended for professional use in clinical laboratory settings. By providing accurate T3 quantification, the assay supports the diagnosis and management of thyroid-related conditions.

Clinical Evidence

Bench testing only. Performance was evaluated by comparing the ARCHITECT Total T3 assay to the predicate AxSYM Total T3 assay using 1120 clinical specimens. Statistical analysis included least squares linear regression (correlation coefficient = 0.950, slope = 0.86, intercept = 0.22 ng/mL) and Passing-Bablok regression (correlation coefficient = 0.950, slope = 1.08, intercept = -0.04 ng/mL).

Technological Characteristics

Chemiluminescent Microparticle Immunoassay (CMIA) technology. Analyte: total triiodothyronine (T3). Sample types: human serum and plasma (lithium heparin, sodium heparin, potassium EDTA). System: Abbott ARCHITECT i System. Calibration: ARCHITECT Total T3 Calibrators. Controls: ARCHITECT Total T3 Controls.

Indications for Use

Indicated for the quantitative determination of total triiodothyronine (total T3) in human serum and plasma as an aid in the assessment of thyroid status.

Regulatory Classification

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.

Predicate Devices

• AxSYM® Total T3 assay

Submission Summary (Full Text)

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K983434

## 510(k) Summary Abbott ARCHITECT™ Total T3

## 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.

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

Substantial equivalence has been demonstrated between the ARCHITECT Total T, assay and the AxSYM® Total T3 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 1120 specimens, gave the following parameter estimates: correlation coefficient = 0.950, slope = 0.86 and v-axis intercept = 0.22 ng/mL. Passing-Bablok linear regression analysis of an ARCHITECT Total T2 vs. AxSYM Total T2 comparison, using 1120 specimens, gave the following parameter estimates: correlation coefficient = 0.950, slope = 1.08 and yaxis intercept = - 0.04 ng/mL.

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 T2 assay.

Prepared and Submitted September 28, 1998 by: April Veoukas, J.D. Senior Regulatory Specialist ADD Regulatory Affairs [phone] Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537

ARCHITECT™ Total T, 510(k) September 1998

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Public Health Service

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. April Veoukas, J.D. Senior Regulatory Specialist ADD Regualtory Affairs Abbott Laboratories 200 Abbott Park Road Abbott Park, Illinois 60064-3537 Re: K983434 Trade Name: Abbott ARCHITECT™ Total T3 Product Code: CDP Regulatory Class: II JIT II JJX I September 28, 1998 Dated: 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbrandinq 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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): 1 983434

Abbott ARCHITECT™ Total T2 Device Name:

Indications For Use:

The ARCHITECT™ Total T3 (TT) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total triiodothyronine (total T3) in human serum and plasma. The ARCHITECT Total T, assay is to be used as an aid in the assessment of thyroid status.

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use_ (Per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. k983434