ACS:CENTAUR CEA

K981478 · Chiron Diagnostics Corp. · DHX · Aug 12, 1998 · Immunology

Device Facts

• Record ID: K981478
• Device Name: ACS:CENTAUR CEA
• Applicant: Chiron Diagnostics Corp.
• Product Code: DHX · Immunology
• Decision Date: Aug 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Indications for Use

For the quantitative determination of carcinoembryonic antigen in serum to aid in the management of cancer patients in whom changing concentrations of CEA are observed using the Chiron Diagnostics ACS:Centaur Automated Chemiluminescence Systems.

Device Story

The ACS:Centaur CEA is a two-site sandwich immunoassay for quantitative serum CEA measurement. It utilizes direct chemiluminometric technology on the ACS:Centaur Automated Chemiluminescence System. The assay employs a polyclonal rabbit anti-CEA antibody labeled with acridinium ester (Lite Reagent) and a monoclonal mouse anti-CEA antibody coupled to paramagnetic particles (Solid Phase). The system detects relative light units (RLUs), which are directly proportional to the CEA concentration in the patient sample. Used in clinical laboratory settings to monitor cancer patients by tracking CEA concentration changes over time.

Clinical Evidence

Bench testing only. Accuracy was evaluated by comparing 284 serum samples (range 0.5 to 78.5 ng/mL) between the ACS:Centaur and the predicate ACS:180 system. Results showed a correlation coefficient (r) of 0.99 with the regression equation: ACS:Centaur CEA = 0.97 (ACS:180 CEA) - 0.04 ng/mL. The assay demonstrated a minimum detectable concentration of 0.5 ng/mL and a measurement range up to 100 ng/mL.

Technological Characteristics

Two-site sandwich chemiluminescence immunoassay. Reagents include acridinium ester-labeled polyclonal rabbit anti-CEA antibody and monoclonal mouse anti-CEA antibody coupled to paramagnetic particles. Operates on the ACS:Centaur Automated Chemiluminescence System. Quantitative measurement based on RLU detection.

Indications for Use

Indicated for the quantitative determination of carcinoembryonic antigen (CEA) in serum to aid in the management of cancer patients in whom changing concentrations of CEA are observed.

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 CEA Immunoassay (P930017)

Submission Summary (Full Text)

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KC 981478

# AUG 1 2 1998

## Company Confidential Summary of Safety and Effectiveness

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

## 1. Submitter Information

Thomas F. Flynn Contact person: Chiron Diagnostics Corporation Address: 63 North Street Medfield, MA 02052

> Phone: [phone] FAX: [phone] e-mail: [e-mail] -

Date Summary Prepared:

April 20, 1998

#### 2. Device Information

| Proprietary Name: | ACS:Centaur CEA |
|----------------------|---------------------------------------------------------|
| Common Name: | CEA Immunoassay |
| Classification Name: | Reclassified to Class II, classification number unknown |

## 3. Predicate Device Information

| Name: | ACS:180 CEA Immunoassay |
|----------------|-----------------------------------------|
| Manufacturer: | Chiron Diagnostics |
| 510(k) Number: | P930017 (note reclassified to class II) |

#### 4. Device Description

The Chiron Diagnostics ACS:Centaur CEA immunoassay is a two-site immunoassay using direct chemiluminometric technology, which uses constant amounts of two antibodies. The first antibody, in the Lite Reagent, is a purified polyclonal rabbit anti-CEA antibody labeled with acridinium ester. The second antibody, in the Solid Phase, is a monoclonal mouse anti-CEA antibody covalently coupled to paramagnetic particles. A direct relationship exists between the amount of CEA present in the patient sample and the amount of relative light units (RLU's) detected by the system.

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#### Company Confidential

#### 5. Statement of Intended Use

(

For the quantitative determination of carcinoembryonic antigen in serum to aid in the management of cancer patients in whom changing concentrations of CEA are observed using the Chiron Diagnostics ACS:Centaur Automated Chemiluminescence Systems.

#### Summary of Technological Characteristics 6.

The Chiron Diagnostics ACS:Centaur immunoassay is a two-site sandwich Chemiluminescence immunoassay.

#### 7. Performance Data

# Sensitivity

The ACS:Centaur Immunoassay measures CEA concentration up to 100 ng/mL with a minimum detectable concentration of 0.5 ng/mL.

## Accuracy

For 284 samples in the range of 0.5 to 78.5 ng/mL, the correlation between the ACS:Centaur CEA and the ACS:180 CEA is described by the equation:

ACS:Centaur CEA = 0.97 (ACS:180 CEA) =0.04 ng/mL

Correlation coefficient (r) = 0.99

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

2098 Gaither Road Rockville MD 20850

Food and Drug Administration

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle.

AUG 1 2 1998

Mr. Thomas F. Flynn Manager, Regulatory Affairs & Compliance Chiron Diaqnostics Corporation 63 North Street Medfield, Massachusetts 02052

Re : K981478/S1 Trade Name: ACS:Centaur CEA Regulatory Class: II Product Code: DHX Dated: August 3, 1998 Received: August 4, 1998

Dear Mr. Flynn:

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, qood 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 requlations affectinq 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 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 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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#### 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 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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Company Confidential

Page of of of of an

510(k) Number (if known):

Device Name: Chiron Diagnostics ACS:Centaur CEA Immunoassay

Indications for Use:

The Chiron Diagnostics ACS:Centaur CEA Immunoassay is for the quantitative determination of carcinoembryonic antigen in serum to aid in the management of cancer patients in whom changing concentrations of CEA are observed using the Chiron Diagnostics ACS:Centaur Automated Chemiluminescence Systems.

Peter E. Maher

Division Sign-Division of Clinical 510(k) Numb

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

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)

ACS:Centaur 510(k)

22 April, 1998