ABBOTT ARCHITECT FREE T3

K983439 · Abbott Laboratories · CDP · Nov 20, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983439
• Device Name: ABBOTT ARCHITECT FREE 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™ Free T3 (FT3) 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 Story

The ARCHITECT Free T3 assay is a Chemiluminescent Microparticle Immunoassay (CMIA) designed for use on the Abbott ARCHITECT i System. It measures free triiodothyronine (free T3) levels in human serum and plasma samples (lithium heparin, sodium heparin, or potassium EDTA). The assay utilizes specific calibrators and controls to verify accuracy and precision. It is intended for use by clinical laboratory professionals to assist in the assessment of a patient's thyroid status. The system processes samples to produce quantitative results, which are then used by clinicians to inform diagnostic and therapeutic decisions regarding thyroid function.

Clinical Evidence

Bench testing only. Comparison study performed using 1101 clinical specimens between the ARCHITECT Free T3 assay and the AxSYM Free T3 assay. Results showed a correlation coefficient of 0.958. Least squares linear regression: slope 0.82, y-intercept 0.94 pg/mL. Passing-Bablok regression: slope 1.05, y-intercept 0.21 pg/mL.

Technological Characteristics

Chemiluminescent Microparticle Immunoassay (CMIA) technology. Designed for use on the Abbott ARCHITECT i System. Analyzes human serum and plasma samples. Quantitative measurement of free T3.

Indications for Use

Indicated for the quantitative determination of free triiodothyronine (free 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® Free T3 assay

Submission Summary (Full Text)

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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 [phone] 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 [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, "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 [phone] or [phone], 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:

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | |
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| Over-The-Counter Use<br>(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)