ABBOTT ARCHITECT TESTOSTERONE

K983212 · Abbott Laboratories · CDZ · Nov 18, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983212
• Device Name: ABBOTT ARCHITECT TESTOSTERONE
• Applicant: Abbott Laboratories
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1680
• Device Class: Class 1

Intended Use

Abbott ARCHITECT Testosterone is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma on the Abbott ARCHITECT i System. Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Device Story

Abbott ARCHITECT Testosterone is a Chemiluminescent Microparticle Immunoassay (CMIA) for quantitative testosterone measurement in human serum and plasma. Operated on the automated ARCHITECT i System in clinical laboratory settings. Uses competitive immunoassay principle with testosterone-specific antibodies. System processes samples, performs assay, and provides quantitative results to clinicians. Results assist in diagnosing/treating androgen-related disorders including hypogonadism, puberty abnormalities, impotence, hirsutism, and virilization. Benefits patients by providing accurate hormone level data for clinical decision-making.

Clinical Evidence

Bench testing only. Correlation study comparing ARCHITECT Testosterone to Chiron Diagnostics ACS:180 Testosterone assay using 607 clinical specimens. Results: correlation coefficient 0.986, slope 0.89 (95% CI 0.88-0.90), y-intercept -0.02 ng/mL (95% CI -0.08 to 0.04).

Technological Characteristics

Chemiluminescent Microparticle Immunoassay (CMIA). Competitive immunoassay format using testosterone-specific antibodies. Designed for use on the automated ARCHITECT i System. Quantitative output.

Indications for Use

Indicated for quantitative determination of testosterone in human serum and plasma to aid in diagnosis and treatment of androgen-related disorders. Patient populations include males with hypogonadism, delayed/precocious puberty, or impotence; and females with hirsutism or virilization associated with tumors, polycystic ovaries, or adrenogenital syndromes.

Regulatory Classification

Identification

A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Predicate Devices

• Chiron Diagnostics ACS:180 Testosterone assay

Submission Summary (Full Text)

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## 510(k) Summary Abbott ARCHITECT™ Testosterone

## Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

The following information as presented in the Premarket Notification [510(k)] for The Ionowing ----------------------------------------------------------------------------------------------------------------------------------------------------------------equivalent determination.

ARCHITECT Testosterone is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Testosterone is calibrated with Abbott ARCHITECT Testosterone Calibrators. Abbott ARCHITECT Testosterone 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 Testosterone assay and the Chiron Diagnostics ACS:180® Testosterone assay. The intended use of the ARCHITECT Testosterone assay is for the quantitative determination of testosterone in human serum and plasma. The intended use of the Chiron Diagnostics ACS:180 Testosterone assay is for the quantitative determination of total testosterone (bound and unbound) in serum. Both assay are competitive immunoassays that use antibodies specific for testosterone and are performed on fully automated immunoassay systems. A least squares linear regression analysis between these two assays, using 607 specimens, yielded a correlation coefficient of 0.986, slope of 0.89 (95% Confidence Interval [CI] of 0.88 to 0.90), and y-axis intercept of -0.02 ng/mL (95% CI of -0.08 to 0.04).

In conclusion, these data demonstrate that the ARCHITECT Testosterone assay is as safe and effective as, and is substantially equivalent to, the Chiron Diagnostics ACS:180 Testosterone assay.

Prepared and Submitted September 11, 1998, by: Karen L. Gates, M.S. Sr. Regulatory Specialist ADD Regulatory Affairs [phone] Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Ms. Karen L. Gates, M.S. Senior Regulatory Specialist ADD Regulatory Affairs NOV 1 8 1998 Abbott Laboratories Diagnostics Division 200 Abbott Park Road Abbott Park, Illinois 60064-3537 Re: K983212 Trade Name: Abbott ARCHITECT™ Testosterone Product Code: CDZ Requlatory Class: I ris II JJX I

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JJE I Dated: September 11, 1998 September 14, 1998 Received:

Dear Ms. Gates:

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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory 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.

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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 requlation 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 Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known): K983212 Device Name: Abbott ARCHITECT™ Testosterone

Indications For Use:

Abbott ARCHITECT Testosterone is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma on the Abbott ARCHITECT i System. Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K-983212

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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