ACS:CENTAUR AFP

K981592 · Chiron Diagnostics Corp. · LOQ · Jul 7, 1998 · Immunology

Device Facts

• Record ID: K981592
• Device Name: ACS:CENTAUR AFP
• Applicant: Chiron Diagnostics Corp.
• Product Code: LOQ · Immunology
• Decision Date: Jul 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Indications for Use

The intended use of ACS:Centaur AFP Immunoassay is for the quantitative determination of alpha-fetoprotein (AFP) in the following: - human serum and in amniotic fluid from specimens obtained at 15 to 20 weeks gestation, * as an aid in detecting open neural defects (NTD) when used in conjunction with ultrasonography and amniography testing, - human serum, as an aid in managing non-seminomatous testicular cancer when used in * conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the Chiron Diagnostics ACS:Centaur Automated Chemiluminescence System.

Device Story

ACS:Centaur AFP Immunoassay is a two-site sandwich chemiluminescence immunoassay for quantitative AFP measurement. Input: human serum or amniotic fluid samples. Principle: uses Lite Reagent (polyclonal rabbit anti-AFP labeled with acridinium ester) and Solid Phase (monoclonal mouse anti-AFP coupled to paramagnetic particles). System detects relative light units (RLU) proportional to AFP concentration. Used in clinical laboratories; operated by trained laboratory personnel. Output: AFP concentration (ng/mL). Healthcare providers use results alongside ultrasonography, amniography, physical exams, and histology to aid in NTD detection or testicular cancer management. Benefits include standardized, automated quantitative assessment of AFP levels.

Clinical Evidence

Bench testing only. Correlation study performed on 498 serum samples comparing ACS:Centaur AFP to the predicate ACS:180 AFP. Results showed a correlation coefficient (r) of 0.99, with the regression equation: ACS:Centaur AFP = 1.05 (ACS:180 AFP) - 0.3 ng/mL. Analytical sensitivity (minimum detectable concentration) is 1.3 ng/mL, with a measurement range up to 1000 ng/mL.

Technological Characteristics

Two-site sandwich chemiluminescence immunoassay. Reagents: polyclonal rabbit anti-AFP (acridinium ester labeled) and monoclonal mouse anti-AFP (paramagnetic particle coupled). Energy source: chemiluminescence detection system. Platform: ACS:Centaur Automated Chemiluminescence System. Connectivity: integrated system.

Indications for Use

Indicated for quantitative determination of AFP in human serum and amniotic fluid (15-20 weeks gestation) to aid in detecting open neural tube defects (NTD) and in human serum to aid in managing non-seminomatous testicular 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

• ACS:180 AFP Immunoassay (P920030)

Submission Summary (Full Text)

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

K981592

#### 7 1998 JUL

## Company Confidential Summary of Safety and Effectiveness

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

## 1. Submitter Information

Contact person:

Address:

Thomas F. Flynn

Chiron Diagnostics Corporation 63 North Street Medfield, MA 02052

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

Date Summary Prepared:

April 20, 1998

### 2. Device Information

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

#### 3. Predicate Device Information

| Name: | ACS:180 AFP Immunoassay |
|----------------|-----------------------------------------|
| Manufacturer: | Chiron Diagnostics |
| 510(k) Number: | P920030 (note reclassified to class II) |

## 4. Device Description

The Chiron Diagnostics ACS:Centaur AFP 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-AFP antibody labeled with acridinium ester. The second antibody, in the Solid Phase, is a monoclonal mouse anti-AFP antibody covalently coupled to paramagnetic particles. A direct relationship exists between the amount of AFP present in the patient sample and the amount of relative light units (RLU's) detected by the system.

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

## Company Confidential

## 5. Statement of Intended Use

The intended use of ACS:Centaur AFP Immunoassay is for the quantitative determination of alpha-fetoprotein (AFP) in the following:

- human serum and in amniotic fluid from specimens obtained at 15 to 20 weeks gestation, * as an aid in detecting open neural defects (NTD) when used in conjunction with ultrasonography and amniography testing,
- human serum, as an aid in managing non-seminomatous testicular cancer when used in * conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the Chiron Diagnostics ACS:Centaur Automated Chemiluminescence System.

#### Summary of Technological Characteristics દ.

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

#### Performance Data 7.

#### Sensitivity

The ACS:Centaur AFP Immunoassay measures AFP concentration up to 1000 ng/mL with a minimum detectable concentration of 1.3 ng/mL.

## Accuracy

For 498 serum samples in the range of 2.0 to 943.6 ng/mL, the correlation between the ACS:Centaur AFP and the ACS:180 AFP is described by the equation:

ACS:Centaur AFP = 1.05 (ACS:180 AFP) = - 0.3 ng/mL

Correlation coefficient (r) = 0.99

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on one line. The text appears to be extracted from a document or sign.

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle symbol on the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Thomas F. Flynn Manager, Requlatory Affairs & Compliance Chiron Diagnostics Corporation 63 North Street Medfield, Massachusetts 02052-1688

7 1998 JUL

Re : K981592 Trade Name: ACS: Centaur AFP Requlatory Class: II Product Code: LOQ Dated: April 30, 1998 Received: May 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 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, Druq, 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 requirement, 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.

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

Page 2

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 fitro 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 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): K981592

Device Name: Chiron Diagnostics ACS:Centaur AFP Immunoassay

Indications for Use:

10:39

The ACS:Centaur AFP Immunoassay is for the quantitative determination of alpha-fetoprotein (AFP) in the following:

- human serum, as an aid in managing non-seminomatous testicular cancer when used in * conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the Chiron Diagnostics ACS:Centaur Automated Chemiluminescence System.
Pete E. Mason

Division of Clinical Laboratory I 510(k) Numbe

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

L Prescription Use (Per 21 CFR 801.109)

OR

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

Premarket Notification - 510(k) Chiron ACS:Centaur AFP Immunoassay

ACS:Centaur 510(k)

29 June, 1998