ELECSYS CA 125 II

K972162 · Boehringer Mannheim Corp. · LTK · Mar 18, 1998 · Immunology

Device Facts

• Record ID: K972162
• Device Name: ELECSYS CA 125 II
• Applicant: Boehringer Mannheim Corp.
• Product Code: LTK · Immunology
• Decision Date: Mar 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Indications for Use

Immunoassay for the in vitro determination of OC 125 reactive determinants. These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer, excluding those with cancer of low malignant potential. The Elecsys® CA 125II is indicated for use as an aid in the detection of residual or recurrent ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. The Elecsys CA 125II assay is further indicated for serial measurement of CA 125II to aid in the management of cancer patients.

Device Story

Elecsys CA 125 II is an in vitro diagnostic immunoassay; measures OC 125 reactive determinants in serum/plasma. Uses sandwich test principle: biotinylated monoclonal antibody and ruthenium-labeled monoclonal antibody bind to CA 125 II; streptavidin-coated microparticles capture complex. Measuring cell uses magnetic capture and electrochemiluminescence detection; photomultiplier measures light emission. Results calculated via instrument-specific calibration curve and master curve from reagent bar code. Used in clinical laboratories; operated by trained personnel. Provides quantitative results to assist clinicians in monitoring ovarian cancer patients and identifying residual/recurrent disease.

Clinical Evidence

Bench testing included precision (NCCLS recommendations), lower detection limit, linearity, and interference studies (hemoglobin, biotin, triglyceride, bilirubin, rheumatoid factor). Clinical evidence included correlation studies with the predicate device and serial monitoring of patients diagnosed and treated for ovarian cancer.

Technological Characteristics

Sandwich immunoassay; electrochemiluminescence detection; streptavidin-coated microparticles; ruthenium-labeled monoclonal antibodies; biotinylated monoclonal antibodies. Instrument-based; uses reagent bar code for master curve data. 18-minute assay duration.

Indications for Use

Indicated for women with primary epithelial invasive ovarian cancer (excluding low malignant potential) to aid in detecting residual or recurrent carcinoma post-first-line therapy and for serial monitoring to aid in patient management.

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

• CENTOCOR CA 125 II RIA

Submission Summary (Full Text)

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K972162

| MAR 18 1998 | 510(k) Summary |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
| 1) Submitter<br>name, address,<br>contact | Boehringer Mannheim Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone] |
| | Contact Person: LeeAnn Chambers, RAC<br>Date Prepared: June 5, 1997 |
| 2) Device name | Proprietary name: Elecsys® CA 125 IITM<br>Common name: Epithelial Ovarian Tumor Associated Antigen |
| | Classification name: Tumor Associated Antigen Immunological Test System |
| 3) Predicate<br>device | We claim substantial equivalence to CENTOCOR® CA 125 IITM RIA. |
| 4) Device<br>Description | The Elecsys® CA 125 IITM employs a sandwich test principle with<br>monoclonal antibodies directed against CA 125 II and with streptavidin<br>microparticles and electrochemiluminescence detection. |
| | Total duration of assay: 18 minutes.<br>• 1st Incubation: 40 µl of sample a biotinylated monoclonal CA 125 II-<br>specific antibody and a monoclonal CA 125 II-specific antibody labeled<br>with a ruthenium complex react to form a sandwich complex.<br>• 2nd Incubation: after the addition of streptavidin-coated microparticles, the<br>complex becomes bound to the solid phase via interaction of biotin and<br>streptavidin. |
| 4) Device<br>Description | • The reaction mixture is aspirated into the measuring cell where the<br>microparticles are magnetically captured onto the surface of the electrode.<br>Unbound substances are then removed with ProCell. Application of a<br>voltage to the electrode then induces chemiluminescent emission which is<br>measured by a photomultiplier.<br>• Results are determined via a calibration curve which is instrument-<br>specifically generated by 2-point calibration and a master curve provided<br>via the reagent bar code. |
| 5.<br>Intended use | Immunoassay for the in vitro determination of OC 125 reactive determinants.<br>These determinants are associated with a high molecular weight glycoprotein<br>in serum and plasma of women with primary epithelial invasive ovarian<br>cancer, excluding those with cancer of low malignant potential. The<br>Elecsys® CA 12511 is indicated for use as an aid in the detection of residual or<br>recurrent ovarian carcinoma in patients who have undergone first-line therapy<br>and would be considered for diagnostic second-look procedures. The Elecsys<br>CA 125II assay is further indicated for serial measurement of CA 125II to aid<br>in the management of cancer patients. |
| 6) Comparison<br>to predicate<br>device | The Boehringer Mannheim Elecsys CA 125 II is substantially equivalent to<br>other products in commercial distribution intended for similar use. Most<br>notably it is substantially equivalent to the currently marketed CENTOCOR<br>CA 125 II RIA.<br>Studies performed include:<br>• evaluation of assay precision according to NCCLS recommendations,<br>• determination of the lower detection limit,<br>• demonstration of linearity,<br>• correlation with the predicate device,<br>• evaluation of the effect of various endogenous substances (hemoglobin,<br>biotin, triglyceride, bilirubin, and rheumatoid factor), and commonly used<br>pharmaceutical compounds, and serum / plasma sample comparisons,<br>• determination of hook effect, and<br>• stability studies. |
| | In addition, comparisons of the Elecsys CA 125 II and the predicate device<br>were performed with samples from serially monitored patients diagnosed and<br>treated for ovarian cancer. |

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## 510(k) Summary, Continued

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MAR 18 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Patricia M. Klimley Manager, Regulatory Affairs Boehringer Mannheim Corp. Laboratory Diagnostics 4300 Hacienda Drive P.O. Box 9002 Pleasanton, CA 94566-0900

Re : K972162 Trade Name: Elecsys® CA 125 IITM Requlatory Class: II Product Codes: LTK Dated: December 17, 1997 Received: December 18, 1997

Dear Ms. Klimely:

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify-such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Druq Administration (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 requlations.

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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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

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

Enclosure

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510(k) Number (if known): Device Name: Elecsys CA 125 II Indications for Use:

Immunoassay for the in vitro determination of OC 125 reactive determinants. These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer, excluding those with cancer of low malignant potential. The Elecsys® CA 125II is indicated for use as an aid in the detection of residual or recurrent ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. The Elecsys CA 125II is further indicated for serial measurement of CA 125II to aid in the management of cancer patients

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Deborah M. Moore
for Dr. Peter Moskin

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K972162

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)