ABBOTT ARCHITECT FREE T4

K983417 · Abbott Laboratories · CEC · Nov 20, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983417
• Device Name: ABBOTT ARCHITECT FREE T4
• Applicant: Abbott Laboratories
• Product Code: CEC · Clinical Chemistry
• Decision Date: Nov 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1695
• Device Class: Class 2

Intended Use

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

Device Story

ARCHITECT Free T4 is a Chemiluminescent Microparticle Immunoassay (CMIA) for quantitative measurement of free thyroxine in human serum or plasma (lithium heparin, sodium heparin, or potassium EDTA). Used on the Abbott ARCHITECT i System; operated by laboratory personnel. The assay utilizes specific reagents and calibrators to measure free T4 levels. Results are used by clinicians as an aid in assessing patient thyroid status. The system provides automated processing and analysis of samples to determine concentration, supporting clinical diagnostic decision-making regarding thyroid function.

Clinical Evidence

Bench testing only. Performance established through comparative analysis of 1250 clinical specimens against the AxSYM Free T4 predicate. Correlation coefficient of 0.932 reported for both least squares and Passing-Bablok regression analyses.

Technological Characteristics

Chemiluminescent Microparticle Immunoassay (CMIA). Designed for use on the Abbott ARCHITECT i System. Analyte: free thyroxine. Sample types: human serum, lithium heparin plasma, sodium heparin plasma, potassium EDTA plasma.

Indications for Use

Indicated for the quantitative determination of free thyroxine (free T4) in human serum and plasma as an aid in the assessment of thyroid status.

Regulatory Classification

Identification

A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Predicate Devices

• AxSYM® Free T4 (K983417)

Submission Summary (Full Text)

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K983417

## 510(k) Summary Abbott ARCHITECT™ Free 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™ 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 or plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Free T, is calibrated with ARCHITECT Free T. Calibrators. ARCHITECT Free T. Controls are assaved 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 1250 specimens, gave the following parameter estimates: correlation coefficient = 0.932, slope = 0.81 and y-axis intercept = 0.23 ng/dL. Passing-Bablok linear regression analysis of an ARCHITECT Free T , vs. AxSYM Free T , comparison, using 1250 specimens, gave the following parameter estimates: correlation coefficient = 0.932, slope = 0.98 and y-axis intercept = 0.01 ng/dL.

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

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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 Requlatory Specialist ADD Requaltory Affairs Abbott Laboratories 200 Abbott Park Road Abbott Park, Illinois 60064-3537 Re: K983417 Abbott ARCHITECT™ Free T4 Trade Name: Product Code: Regulatory Class: II

CEC JIT II JX 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 Requlation (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 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 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, "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 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): 1983417

Abbott ARCHITECT™ Free T4 Device Name: _________

Indications For Use:

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

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Image /page/3/Figure/5 description: The image shows a form with the title "Concurrence of CDRH, Office of Device Evaluation (ODE)". The form has two options: "Prescription Use" and "Over-The-Counter Use". The "Prescription Use" option is checked, and the 510(k) Number is "K983417".