ABBOTT ARCHITECT CEA

K990774 · Abbott Laboratories · DHX · May 11, 1999 · Immunology

Device Facts

• Record ID: K990774
• Device Name: ABBOTT ARCHITECT CEA
• Applicant: Abbott Laboratories
• Product Code: DHX · Immunology
• Decision Date: May 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

The ARCHITECT CEA assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Carcinoembryonic Antigen (CEA) in human serum and plasma on the ARCHITECT i System. The ARCHITECT CEA assay is to be used as an aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed.

Device Story

ARCHITECT CEA is a chemiluminescent microparticle immunoassay (CMIA) for quantitative measurement of CEA in human serum and plasma. Operated on the ARCHITECT i System in clinical laboratory settings by trained personnel. Uses mouse monoclonal antibodies to detect CEA; results provide clinicians with quantitative data to monitor cancer patients; aids in prognosis and management by tracking changing CEA concentrations over time. System automates assay processing; results are reported to healthcare providers for clinical decision-making regarding patient status.

Clinical Evidence

Bench testing only. Comparison study against predicate AxSYM CEA assay using 1,069 clinical specimens. Least squares analysis: r=0.991, slope=0.92 (95% CI: 0.91-0.93), y-intercept=0.85 ng/mL. Passing-Bablok analysis: r=0.991, slope=0.97 (95% CI: 0.96-0.98), y-intercept=0.28 ng/mL. Results demonstrate similar performance and trending.

Technological Characteristics

Chemiluminescent Microparticle Immunoassay (CMIA) technology. Uses mouse monoclonal antibodies. Designed for use on the ARCHITECT i System. Quantitative measurement of CEA in serum and plasma.

Indications for Use

Indicated for the quantitative determination of Carcinoembryonic Antigen (CEA) in human serum and plasma to aid in the prognosis and management of cancer patients exhibiting changing CEA concentrations.

Regulatory Classification

Identification

A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Special Controls

*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Predicate Devices

• Abbott AxSYM® CEA assay

Submission Summary (Full Text)

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## 510(k) Summary Abbott ARCHITECT™ CEA

## 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 CEA constitutes data supporting a substantially equivalent determination.

ARCHITECT CEA is a Chemiluminescent Microparticle Immunoassay for the quantitative determination of CEA in human serum and plasma. ARCHITECT CEA is calibrated with ARCHITECT CEA Calibrators. ARCHITECT CEA 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 CEA assay and the Abbott AxSYM® CEA assay, a microparticle enzyme immunoassay. The intended use of both assays is for the quantitative determination of CEA in human serum and plasma, and to be used as an aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed. Both assays use the same mouse monoclonal antibodies. A least squares correlation analysis between these two assays, using 1,069 specimens, yielded a correlation coefficient of 0.991, slope of 0.92 (95% confidence interval of 0.91 to 0.93), and y-intercept of 0.85 ng/mL (95% confidence interval of 0.01 to 1.69). A Passing-Bablok correlation analysis, using 1,069 specimens, vielded a correlation coefficient of 0.991, slope of 0.97 (95% confidence interval of 0.96 to 0.98), and y-intercept of 0.28 ng/mL (95% confidence interval of 0.26 to 0.30). Both assays show similar distribution of CEA concentrations across various conditions. Both assays also show similar trending when monitoring patients in whom changing concentrations of CEA are observed.

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

Prepared and Submitted March 8, 1999 by:

Karen L. Gates, M.S. Senior Regulatory Specialist ADD Regulatory Affairs 1-847-938-0538

Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064

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MAY 1 1 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Karen L. Gates, M.S. Senior Regulatory Specialist ADD Regualtory Affairs D9V6 AP31 200 Abbott Park Road Abbott Park, Illinois 60064-3537

Re: K990774 Trade Name: Abbott ARCHITECT™ CEA Regulatory Class: II Product Code: DHX Dated: March 8, 1999 Received: March 9, 1999

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 Regulations, 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 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 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): K990774 Device Name: Abbott ARCHITECT™ CEA Indications For Use:

> The ARCHITECT CEA assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Carcinoembryonic Antigen (CEA) in human serum and plasma on the ARCHITECT i System. The ARCHITECT CEA assay is to be used as an aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K970774 |

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |