CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY

K982680 · Chiron Diagnostics Corp. · MOI · Oct 15, 1998 · Immunology

Device Facts

• Record ID: K982680
• Device Name: CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
• Applicant: Chiron Diagnostics Corp.
• Product Code: MOI · Immunology
• Decision Date: Oct 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Indications for Use

The Chiron Diagnostics ACS:Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the Chiron Diagnostics ACS:Centaur" Automated Chemiluminescence System. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27,25 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 breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

Device Story

ACS:Centaur BR Immunoassay is an in vitro diagnostic test for quantitative measurement of CA 27.29 antigen in human serum. Device utilizes automated chemiluminescence system; competitive immunoassay format. Input: human serum sample. Process: sample incubated with monoclonal mouse antibody (MAb B27.29) labeled with acridinium ester and solid phase (purified CA 27.29 coupled to paramagnetic particles) for 7.5 minutes. Output: quantitative CA 27.29 concentration (up to 450 U/mL). Used in clinical laboratory settings by trained personnel. Results assist clinicians in monitoring breast cancer recurrence in patients previously treated for Stage II/III disease and managing metastatic breast cancer progression/regression. Benefits include standardized serial monitoring of cancer antigen levels to inform clinical decision-making.

Clinical Evidence

Bench testing only. Analytical sensitivity (minimum detectable concentration) is 3.5 U/mL. Accuracy evaluated using 225 samples (range 6.54–448.94 U/mL) compared to predicate ACS:180 BR assay; correlation coefficient (r) = 0.99, with regression equation: ACS:Centaur BR = 1.00 (ACS:180 BR) - 0.94 U/mL.

Technological Characteristics

Fully automated, competitive immunoassay using direct chemiluminescent technology. Lite Reagent: monoclonal mouse antibody (MAb B27.29) labeled with acridinium ester. Solid Phase: purified CA 27.29 covalently coupled to paramagnetic particles. Measures CA 27.29 up to 450 U/mL. System: ACS:Centaur Automated Chemiluminescence System.

Indications for Use

Indicated for quantitative serial determination of CA 27.29 in human serum to monitor patients previously treated for Stage II or Stage III breast cancer, and to aid in management of metastatic breast cancer by monitoring disease progression or regression.

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

• ACS:180 BR Immunoassay (K981698)

Submission Summary (Full Text)

{0}------------------------------------------------

OCT 1 5 1998

# Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

#### 1. Submitter Information

2.

number

| Contact person: | William J. Pignato |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Address:<br>63 North Street<br>Medfield, MA 02052 | Chiron Diagnostics Corporation |
| Phone:<br>FAX:<br>e-mail: | [phone]<br>[phone]<br>[e-mail] |
| Date Summary Prepared: | July 28, 1998 |
| Device Information | |
| Proprietary Name:<br>Common Name:<br>Classification Name: | ACS:Centaur BR Immunoassay<br>CA 27.29 antigen Immunoassay<br>Reclassified to Class II classification |

#### 3. Predicate Device Information

| Name: | ACS:180 BR Immunoassay |
|----------------|------------------------|
| Manufacturer: | Chiron Diagnostics |
| 510(k) Number: | K981698 |

#### 4. Statement of Intended Use

The Chiron Diagnostics ACS:Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the Chiron Diagnostics ACS:Centaur" Automated Chemiluminescence System. The test is intended for use as an aid in monitoring patients previously treated for Stage Il or Stage III breast cancer. Serial testing for CA 27,25 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 breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

unknown

## 6. Summary of Technological Characteristics

{1}------------------------------------------------

The Chiron Diagnostics ACS:Centaur BR assay is a fully automated, competitive immunoassay using direct, chemiluminescent technology. The Lite Reagent is composed of a monoclonal mouse antibody specific for CA 27.29, labeled with acridinium ester. The antibody used in the assay, MAb B27,29, binds to a peptide epitope in the tandem repeat region of the MUC-1 gene product. The Solid Phase is composed of purified CA 27.29, which is covalently coupled to paramagnetic particles. After onboard pretreatment, the sample is incubated with both Lite Reagent and Solid Phase simultaneously for 7.5 minutes.

## 7. Performance Data

## Sensitivity

The ACS:Centaur BR assay measures CA 27.29 concentrations up to 450 U/mL with a minimum detectable concentration (analytical sensitivity) of 3.5 U/mL.

#### Accuracy

For 225 samples in the range of 6.54 to 448.94 U/mL, the relationship of the ACS:Centaur BR assay to the ACS:180 BR assay is described by the following equation:

ACS:Centaur BR = 1.00 (ACS:180 BR) - 0.94 U/mL Correlation coefficient (r) = 0.99

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the symbol.

OCT 1 5 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. William J. Pignato Director of Requlatory Affairs Chiron Diaqnostics Corporation 63 North Street Medfield, Massachusetts 02052

Re: K982680 ACS:Centaur BR Immunoassay Trade Name: Requlatory Class: İI Product Code: MOI Dated: July 28, 1998 Received: July 31, 1998

Dear Mr. Pignato:

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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 obliqation 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.

{3}------------------------------------------------

Page 2

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 qeneral 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 Putman

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

{4}------------------------------------------------

Company Confidential

Page of

510(k) Number (if known): h 953680

Device Name: Chiron Diagnostics ACS:Centaur BR Immunoassay

Indications for Use:

The Chiron Diagnostics ACS:Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the Chiron Diagnostics ACS:Centaur" Automated Chemiluminescence System. The test is intended for use as an aid in monitoring patients previously treated for Stage III breast cancer. Serial testing for CA 27.29 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 breast cancer patients with metastatic disease by monitoring the progression of disease in response to treatment.

Peter E. Maher

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

(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE, IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use (Per 21 CFR 801.109)

OR

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

ACS:Centaur BR 510(k)

28 July, 1998