ABBOTT ARCHITECT TSH

K983442 · Abbott Laboratories · JLW · Nov 20, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983442
• Device Name: ABBOTT ARCHITECT TSH
• Applicant: Abbott Laboratories
• Product Code: JLW · Clinical Chemistry
• Decision Date: Nov 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended Use

Abbott ARCHITECT™ TSH is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of thyroid stimulating hormone (TSH) in human serum and plasma. The ARCHITECT TSH assay is to be used as an aid in the assessment of thyroid status, diagnosis of thyroid disease, and treatment of thyroid disease.

Device Story

ARCHITECT TSH is a Chemiluminescent Microparticle Immunoassay (CMIA) for quantitative TSH measurement in human serum and plasma. Used on Abbott ARCHITECT i System; operated by laboratory personnel. Device processes patient samples using specific calibrators and controls to ensure accuracy/precision. Output is quantitative TSH concentration, used by clinicians to assess thyroid status and manage thyroid disease. Benefits include standardized, automated diagnostic support for thyroid conditions.

Clinical Evidence

Bench testing only. Comparison study against AxSYM Ultrasensitive hTSH assay using 534 specimens. Least squares linear regression: r=0.987, slope=0.96, y-intercept=-0.7135 uIU/mL. Passing-Bablok regression: r=0.987, slope=0.91, y-intercept=0.0098 uIU/mL.

Technological Characteristics

Chemiluminescent Microparticle Immunoassay (CMIA). Analyte: TSH. Sample types: serum, lithium heparin plasma, sodium heparin plasma, potassium EDTA plasma. Platform: Abbott ARCHITECT i System.

Indications for Use

Indicated for quantitative determination of TSH in human serum and plasma to aid in assessment, diagnosis, and treatment of thyroid disease in patients requiring thyroid status evaluation.

Regulatory Classification

Identification

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Predicate Devices

• AxSYM® Ultrasensitive hTSH assay

Submission Summary (Full Text)

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## NOV 2 0 1998

K.983442

## 510(k) Summary Abbott ARCHITECT™ TSH 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™ TSH constitutes data supporting a substantially equivalent determination.

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

Substantial equivalence has been demonstrated between the ARCHITECT TSH and the AxSYM® Ultrasensitive hTSH assay. The intended use of both assays is for the quantitative determination of human thyroid stimulating hormone (TSH). Both assays can be performed with human serum and plasma (lithium heparin, sodium heparin, or potassium EDTA). The least squares linear regression analysis between these two assays. using 534 specimens, yielded a correlation coefficient of 0.987, slope of 0.96 (95% confidence interval of 0.95 to 0.98), and y-axis intercept of -0.7135 uIU/mL (95% confidence interval of -1.1931 to -0.2339). The Passing-Bablok linear regression analysis between these two assays, using 534 specimens, vielded a correlation coefficient of 0.987, slope of 0.91 (95% confidence interval of 0.90 to 0.92), and y-axis intercept of 0.0098 uIU/mL (95% confidence interval of 0.0019 to 0.0162).

In conclusion, these data demonstrate that the ARCHITECT TSH assay is as safe and effective as, and is substantially equivalent to the AxSYM Ultrasensitive hTSH II assay.

Prepared and Submitted September 29, 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 TSH 5100% September 1998 TH 510K DOC

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

NOV 20 1909

Ms. April Veoukas, J.D. Senior Requlatory Specialist ADD Requaltory Affairs Abbott Laboratories 200 Abbott Park Road Abbott Park, Illinois 60064-3537 Re: K983442

Trade Name: Abbott ARCHITECT™ TSH Requlatory Class: II Product Code: JLW JIT II JJX I Dated: September 29, 1998 September 30, 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 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 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlation (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): 199349

Device Name: Abbott ARCHITECT™ TSH

Indications For Use:

Abbott ARCHITECT™ TSH is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of thyroid stimulating hormone (TSH) in human serum and plasma. The ARCHITECT TSH assay is to be used as an aid in the assessment of thyroid status, diagnosis of thyroid disease, and treatment of thyroid disease.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K983442 |
| Prescription Use <span style="text-decoration:underline;">✓</span><br>(Per 21 CFR 801.109) | OR Over-The-Counter Use ______ |
| | (Optional Format 1-2-96) |