The intended use of the ACS:Centaur system is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assays analysis on clinical specimens using the ACS ilmmunoassays. The system menu will include endocrine, anemia, reproductive, cardiac, therapeutic drug, and infectious disease assays. All assays are based on chemiluminescent technology.

Device Description

The ACS:Centaur system is a stand-alone, continuous operation, immunochemistry analyzer. The system performs the following functions.

aspirates and dispenses samples .
. performs dilutions
adds reagents .
incubates reaction vessels .
separates solid and liquid waste .
measures photon emissions .
performs data reduction .
collects and maintains patient demographics and results .

AI/ML Overview

This document is a 510(k) summary for the ACS:Centaur Analyzer, an automated immunoassay analyzer. The primary purpose of this document is to demonstrate substantial equivalence to a predicate device, the ACS:180® Analyzer. As such, it focuses on comparing the technological characteristics and intended use rather than providing detailed clinical study results with acceptance criteria.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes used for test set and data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used, training set details) cannot be extracted from the provided text. The document does not describe specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or studies that prove the device meets such criteria. Instead, it highlights the device's functional capabilities and its similarity to a previously cleared device.

However, based on the provided text, I can infer the following:

1. A table of acceptance criteria and the reported device performance:

The document describes functional and technological equivalence to a predicate device rather than specific quantitative performance targets. Therefore, a table of "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial (e.g., sensitivity, specificity) is not explicitly provided. The "acceptance criteria" in this context are implied to be that the ACS:Centaur system performs its intended functions similarly to the predicate device, ACS:180® Analyzer.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence to Predicate Device (ACS:180® Analyzer):	The ACS:Centaur system is a "stand-alone, continuous operation, immunochemistry analyzer" that performs functions like aspirating/dispensing samples, performing dilutions, adding reagents, incubating reaction vessels, separating solid/liquid waste, measuring photon emissions, performing data reduction, and collecting/maintaining patient demographics and results.
Technological Equivalence to Predicate Device:	Both ACS:Centaur and ACS:180® utilize "acridinium ester as label and paramagnetic particles as the solid phase." Both "measure the amount of light emitted during the chemiluminescent reaction," with a "direct relationship between the amount of light emitted and amount of antigen in the patient sample." The system supports "competitive binding assays and sandwich assays." It uses a "Master Curve and a two-point, user-initiated calibration" system to eliminate the need for full standard curves or running calibrators with each assay.
Specific Technological Features:	Photomultiplier: Used in photon counting mode. Automated Pipetting: For sample and reagents. Electronic Fluid Sensing: On sample and reagents. Clog Detection: For samples. Random Access and Batch Test Processing. Varied Test Incubations. Human Interface Features: Barcode reading, LIS integration, automated data reduction. Automated Dilution Capabilities. These features collectively represent the device's performance capabilities, which are presented as equivalent or improved compared to the predicate device. The underlying assumption for 510(k) clearance is that these characteristics result in equivalent performance for the stated intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not specified in the provided text. The document describes the device and its intended use but does not detail any specific performance studies or their methodologies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not specified. This document is for an automated immunoassay analyzer, not an imaging device requiring expert interpretation for ground truth. Ground truth for immunoassay devices is typically established through reference methods or established laboratory practices, not expert consensus on qualitative interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not specified. As no specific test set or expert adjudication related to subjective interpretation is mentioned, this information is not present.

5. 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:

Not applicable. The ACS:Centaur is an automated immunoassay analyzer, not an AI-assisted diagnostic tool that involves human readers interpreting results in a MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The device described, the ACS:Centaur, is a standalone automated immunoassay analyzer. Its intrinsic function is to perform tests and provide results without human intervention in the assay execution and initial data reduction. The entire device essentially operates in a "standalone" fashion (algorithm-only if considering the automated testing process as an algorithm). However, the document doesn't detail a specific "standalone performance study" in the context of comparing it against human interpretation, as that's not its intended function. Its performance would be evaluated on its ability to accurately measure biomarkers.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not explicitly stated. For an immunoassay analyzer, ground truth for performance evaluation (e.g., accuracy, precision) would typically be established using reference methods, calibrated standards, or highly characterized biological samples with known analyte concentrations. The document does not detail the specific ground truth methodology used for any performance validation.

8. The sample size for the training set:

Not specified. The document does not refer to a "training set" in the context of machine learning. The "Master Curve" mentioned for calibration might imply a form of system training/calibration, but the sample size for generating this is not provided.

9. How the ground truth for the training set was established:

Not specified. If the "Master Curve" for calibration is considered a form of "training," its ground truth would likely be established using calibrated reference materials or standards with known analyte concentrations. However, the details are not provided.

Summary

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K4 111418
7 1097

ACS Centaur

Summary of Safety and Effectiveness

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

1. Submitters Information

Contact person:	William J. PignatoDirector of Regulatory Affairs
Address:	Chiron Diagnostics Corporation63 North StreetMedfield, MA 02052
Phone:	508 359-3825

April 14, 1997 Date Summary Prepared:

2. Device Information

Proprietary Name:	ACS:Centaur Analyzer
Common Name:	Automated Immunoassay Analyzer
Classification Name:	Photometric Analyzer for Clinical Use
Classification Number:	21 CFR 862.2160, Class I

3. Predicate Device Information

Name:	ACS:180® Analyzer
Manufacturer:	Chiron Diagnostics Corporation (formally Ciba Corning Diagnostics Corp.)
510(k) Number:	D.C. #K902336.

4. Device Description

The ACS:Centaur system is a stand-alone, continuous operation, immunochemistry analyzer. The system performs the following functions.

aspirates and dispenses samples .
. performs dilutions
adds reagents .
incubates reaction vessels .
separates solid and liquid waste .
measures photon emissions .
performs data reduction .
collects and maintains patient demographics and results .

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5. Statement of Intended Use

6. Summary of Technological Characteristics

ACS assays are dedicated for use on the ACS:180® and the ACS:Centaur utilizes acridinium ester as label and paramagnetic particles as the solid phase. Like the ACS:180®, the ACS:Centaur measures the amount of light emitted during the chemiluminescent reaction. There is direct relationship between the amount of light emitted and amount of antigen in the patient sample. The system will measure both competitive binding assavs and sandwich assays.

The ACS:Centaur system uses a Master Curve and a two-point, user-initiated calibration to calibrate all the ACS assays. TThe Master Curve and the two-point calibration system eliminate the need to measure a full standard curve with each assay or to run calibrators each time the assay is run. The system stores the calibration for the interval specified in the assay product inserts.

Other Technological Features include:

Photomultiplier used in the photon counting mode .
Automated pipetting of sample and reagents ●
Electronic Fluid Sensing on sample and reagents ●
Clog detection for samples ●
Random access and batch test processing ●
. Varied test incubations
. Human Interface features including barcode reading, LIS, automated data reduction.
Automated dilution capabilities ●

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a human figure, with three overlapping profiles. The profiles are facing to the right and are connected by flowing lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 17 1997

Thomas F. Flynn

Manager, Requlatory Affairs & Compliance Chiron Diagnostics Corporation 63 North Street Medfield, Massachusetts 02052-1688

Re : K971418 ACS Centaur Analyzer Regulatory Class: I Product Code: JJE June 26, 1997 Dated: Received: June 27, 1997

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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 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 Requlations.

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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 (770) 488-7655.

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/dsmamain.html".

Sincerely yours,
Steven Gutman

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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Page __ of ___________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Chiron Diagnostics ACS:Centaur System ___________________________________________________________________________________________________________________________

Indications for Use:

The intended use of the ACS:Centaur system is an automated immunoassay analyzer The Intended use of the AOO.OChiaan of chamical assays analysis on clinical specimens using the ACS ilmmunoassays. The system menu will include endorine, specificals using the AOO minimanedation drug, and infectious disease assays. All anemia, reproductive, "Cardiac, therefound and is an indirect indicator of thyroid status.4

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

(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)

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$\mathscr{A}$

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.