CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM

K020828 · Bayer Corp. · LTK · Jul 24, 2002 · Immunology

Device Facts

• Record ID: K020828
• Device Name: CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
• Applicant: Bayer Corp.
• Product Code: LTK · Immunology
• Decision Date: Jul 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Indications for Use

For in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and to aid in the management of patients with ovarian carcinoma using the ADVIA Centaur® System. The test is intended for use as an aid in monitoring patients previously treated for ovarian cancer. Serial testing for CA 125 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of ovarian cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment. It is recommended that the Bayer ADVIA Centaur CA 125 II assay be used under the order of a physician trained and experienced in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.

Device Story

ADVIA Centaur CA 125 II is a fully automated, single-step sandwich immunoassay; utilizes direct chemiluminescent technology. Input: human serum sample. Process: sample incubated with Lite Reagent (monoclonal mouse antibodies OC125 labeled with acridinium ester and M11 labeled with fluorescein) and Solid Phase (paramagnetic particles coupled with capture antibody) for 40 minutes; immuno-complex washed; chemiluminescence measured. Output: quantitative CA 125 antigen concentration, directly proportional to chemiluminescence. Used in clinical laboratories; operated by trained technicians. Results provided to physicians experienced in gynecological cancer management to monitor disease progression, regression, or recurrence. Benefits include standardized, automated longitudinal tracking of tumor markers to inform clinical decision-making.

Clinical Evidence

Retrospective clinical study of 44 ovarian cancer patients. Evaluated longitudinal changes in CA 125 II values against clinical status during disease and therapy. Reported sensitivity of 93.5% and specificity of 38.5% for longitudinal measurements.

Technological Characteristics

Fully automated, single-step sandwich immunoassay. Reagents: monoclonal mouse antibodies (OC125, M11), acridinium ester label, fluorescein label, paramagnetic particles. Detection: direct chemiluminescence. System: ADVIA Centaur automated analyzer. Connectivity: automated system integration.

Indications for Use

Indicated for the quantitative, serial determination of CA 125 in human serum to aid in the management of patients with ovarian carcinoma, specifically for monitoring patients previously treated for ovarian cancer, detecting disease recurrence in conjunction with other clinical methods, and monitoring progression or regression of metastatic disease in response to treatment. Not for screening or diagnosis of ovarian cancer.

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

• Bayer Immuno-1 CA 125 II (K983715)

Submission Summary (Full Text)

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# JL 2 4 2002

Page 1 of 2

## Premarket Notification - 510(k)

### ADVIA Centaur 125 Il Immunoassay

### 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness is being submitted in accordance with the requirements of The Safe Medical Devices Act of 1990 (SMDA 1990) and 21 CFR 807.92.

The assigned 510(k) number is:

### 7.1 General Information

Date of Summary Update:

| Applicant: | Kenneth T. Edds, Ph.D.<br>Manager, Regulatory Affairs<br>Business Group Diagnostics<br>511 Benedict Ave.<br>Tarrytown, NY 10591<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner: | Bayer Corporation<br>Business Group Diagnostics<br>511 Benedict Ave.<br>Tarrytown, NY 10591<br>Establishment Registration No: 2432235 |
| Manufacturer: | Bayer Corporation<br>333 Coney Street<br>Walpole, MA 02032<br>Establishment Registration No: 1219913 |
| Device Name: | ADVIA Centaur® CA 125 II assay |
| Common or Usual Name: | Chemiluminescence immunoassay kit for the<br>determination of CA 125 antigen<br>using Bayer Corporation's<br>ADVIA Centaur automated analyzer. |
| Classification: | |
| Name: | Bayer ADVIA Centaur CA 125 II Assay |
| Class: | II |
| CFR: | 21 CFR 866.6010 |
| Product Code: | 82 LTK |

This submission was prepared in accordance with "Guidance Document for Submission of Tumor Associated Antigen Premarket Notifications".

Substantial Equivalence To: Bayer Immuno-1 CA 125 II

> 510(k) Number: K983715

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### 7.2 Intended Use

For in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and to aid in the management of patients with ovarian carcinoma using the ADVIA Centaur® System. The test is intended for use as an aid in monitoring patients previously treated for ovarian cancer. Serial testing for CA 125 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of ovarian cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment. It is recommended that the Bayer ADVIA Centaur CA 125 II assay be used under the order of a physician trained and experienced in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.

### 7.3 Device Description

The ADVIA Centaur CA 125 II assay is a fully automated, single step sandwich immunoassay using direct, chemiluminescent technology. The Lite Reagent is composed of the monoclonal mouse antibody, OC125, specific for CA 125, labeled with acridinium ester and the monoclonal mouse antibody M11, specific for CA 125, labeled with fluorescein. The Solid Phase is composed of purified monoclonal mouse capture antibody, which is covalently coupled to paramagnetic particles. The sample is incubated with both Lite Reagent and Solid Phase simultaneously for 40 minutes. After incubation, the immuno-complex is washed. The measured chemiluminescence is directly proportional to the quantity of CA 15-3 antigen in the sample.

### 7.4 Comparison to the Predicate Device

The ADVIA Centaur CA 125 II immunoassay kit is similar to the Immuno-1 CA 125 II kit in the indications for use, format, performance characteristics, and results. The ADVIA Centaur tests differ mainly in their signal system as compared to the Immuno-1 principle. In the ADVIA Centaur method, a chemiluminogenic molecule (acridinium ester) is used to replace the Alkaline Phosphatase signal used in the Immuno-1 assay.

### 7.5 Equivalence to Predicate Device

For 227 samples in the range of 2.3 to 466.6 U/mL, the relationship of the ADV/A Centaur CA 125 II assay to the Immuno 1™ CA 125 II assay is described by the following equation (calculated using Deming Regression):

ADVIA Centaur CA 125 II = 1.025 (Immuno 1) + 1.14 U/mL

The correlation coefficient r is 0.992

The data demonstrate substantial equivalence of the ADVIA Centaur CA 125 II assay to the FDA-cleared Bayer Immuno-1 CA 125 II assay as an adjunctive test for use in the management (monitoring) of metastatic ovarian cancer patients during the course of disease and therapy and for the detection of disease recurrence.

### 7.6 Monitoring Cancer Patients for Progression or Response

A retrospective clinical study was conducted to evaluate Centaur CA 125 II values in 44 ovarian cancer patients during the course of disease and therapy. Changes in the clinical status of patients were compared to changes in Centaur CA 125 II results. The sensitivity of longitudinal measurements using the method was 93.5% and the specificity was 38.5%.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kenneth T. Edds, Ph.D. Regulatory Affairs Bayer Corporation Business Group Diagnostics 511 Benedict Avenue Tarrytown, NY 10591-5097

JUL 2 4 2002

Re: K020828

Trade Name: Bayer Advia Centaur CA 125 assay Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: II Product Code: LTK Dated: March 12, 2002 Received: March 14, 2002

Dear Dr. Edds:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indication 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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" (21CFR 807,97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

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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Page 1 of 1

510(k) Number (if known): _ KO20828

Device Name: Bayer Diagnostics ADVIA Centaur CA 125 Assay

### Indications for Use:

For in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and to aid in the management of patients with ovarian carcinoma using the ADVIA Centaur® System. The test is intended for use as an aid in monitoring patients previously treated for ovarian cancer. Serial testing for CA 125 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of ovarian cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment. It is recommended that the Baver ADVIA Centaur CA 125 II assay be used under the order of a physician trained and experienced in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.

A. Reeves for S. Altaie

Division Sign-Off) (MVision of Clinical Laborato:

510(k) Number K020828

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)