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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ACS:Centaur CEA Immunoassay, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Sensitivity	Minimum detectable concentration: 0.5 ng/mL
Accuracy (Correlation to predicate device)	ACS:Centaur CEA = 0.97 (ACS:180 CEA) = 0.04 ng/mL, Correlation coefficient (r) = 0.99 (for 284 samples in the range of 0.5 to 78.5 ng/mL)

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 284 samples.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the context of a new device being compared to a legally marketed predicate suggests these were clinical samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given document. The "ground truth" for accuracy in this context is the measurement by the predicate device (ACS:180 CEA), not expert interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable as the evaluation is a direct comparison of quantitative measurements from two immunoassay devices, not expert adjudication of clinical findings.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this was not a MRMC study. This device is an in-vitro diagnostic (IVD) immunoassay, not an AI-powered image analysis or clinical decision support tool designed to assist human readers. Therefore, the concept of human reader improvement with/without AI assistance is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance evaluation of the ACS:Centaur CEA immunoassay device itself. It measures CEA concentration directly from serum samples without human interpretation of raw data in the same way an AI algorithm would operate. Its performance is compared to another device (the predicate), not human performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for accuracy in this study was the quantitative measurement obtained from the predicate device, the ACS:180 CEA Immunoassay. The study sought to demonstrate substantial equivalence to an already legally marketed device.
The sample size for the training set:
- This information is not provided in the document. For an immunoassay device, the "training set" might refer to data used during the development and calibration of the assay, but specific details about this are not included in the 510(k) summary.
How the ground truth for the training set was established:
- This information is not provided in the document. Similar to the training set size, the specifics of how internal calibration standards or reference materials were established during the assay development are beyond the scope of this 510(k) summary.

Summary

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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: (508) 359-3877 FAX: (508) 359-3885 e-mail: thomas.flynn@chirondiag.com -

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

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Company Confidential

5. Statement of Intended Use

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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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:

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)

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

ACS:Centaur 510(k)

22 April, 1998

Regulation Number and Section

§ 866.6010 Tumor-associated antigen immunological test system.

(a)
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.(b)
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.