CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER

K971418 · Chiron Diagnostics Corp. · MOI · Jul 17, 1997 · Immunology

Device Facts

• Record ID: K971418
• Device Name: CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
• Applicant: Chiron Diagnostics Corp.
• Product Code: MOI · Immunology
• Decision Date: Jul 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

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 Story

The ACS:Centaur is a stand-alone, automated immunoassay analyzer for clinical laboratory use. It processes clinical specimens to perform various immunochemical assays. The system automates sample aspiration, dispensing, dilution, reagent addition, incubation, and solid/liquid waste separation. It utilizes chemiluminescent technology, measuring photon emissions via a photomultiplier in photon counting mode to quantify antigens in samples. It supports both competitive binding and sandwich assays. The system features electronic fluid sensing, clog detection, and random access/batch processing. Data reduction, patient demographics, and results are managed via an integrated human interface with barcode reading and LIS connectivity. By automating complex immunoassay workflows, the device provides clinicians with rapid, standardized diagnostic results for endocrine, cardiac, and infectious disease management.

Clinical Evidence

Bench testing only. The device relies on established chemiluminescent immunoassay technology consistent with the predicate device. No clinical trial data was required for this 510(k) submission.

Technological Characteristics

Automated immunoassay analyzer; chemiluminescent detection using acridinium ester label and paramagnetic particles; photomultiplier tube for photon counting; electronic fluid sensing; automated pipetting and dilution; random access/batch processing; LIS connectivity; barcode reader; software-based data reduction.

Indications for Use

Indicated for in vitro diagnostic immunochemical analysis of clinical specimens for endocrine, anemia, reproductive, cardiac, therapeutic drug, and infectious disease conditions. For prescription use only.

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® Analyzer (K902336)

Submission Summary (Full Text)

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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. Pignato<br>Director of Regulatory Affairs |
|-----------------|-------------------------------------------------------------------------|
| Address: | Chiron Diagnostics Corporation<br>63 North Street<br>Medfield, 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

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.

## 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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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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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 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/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

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| Division of Clinical Laboratory Leviges |
| 510(k) Number |

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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)

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