BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER

K032525 · Bayer Healthcare, LLC · NBC · Sep 9, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032525
• Device Name: BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
• Applicant: Bayer Healthcare, LLC
• Product Code: NBC · Clinical Chemistry
• Decision Date: Sep 9, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1117
• Device Class: Class 2

Intended Use

The Bayer ADVIA Centaur is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include endocrine, anemia, allergy, reproductive, cardiovascular, oncology, adrenal, bone metabolism, therapeutic drug, and infectious disease assays. All assays are based on chemiluminescent technology.

Device Story

ADVIA Centaur is a stand-alone, continuous-operation, automated immunochemistry analyzer for clinical laboratories. It processes serum or plasma samples via automated aspiration, dilution, and reagent addition. The system uses chemiluminescent technology with acridinium ester labels and paramagnetic particles. A photomultiplier tube (PMT) measures photon emissions, which are directly proportional to antigen concentration. The device performs data reduction, maintains patient demographics, and provides results via a graphical user interface or LIS connection. It supports random access and batch processing. Operators (lab technicians) use barcode scanners for sample/reagent identification. The system automates calibration using a Master Curve and two-point calibration, reducing manual standard curve requirements. Output assists clinicians in diagnosing and monitoring various disease states, including endocrine, cardiovascular, and infectious conditions.

Clinical Evidence

Bench testing only. No clinical data presented. Substantial equivalence is based on technological comparison and performance verification of the automated immunoassay system.

Technological Characteristics

Automated immunoassay analyzer; chemiluminescent detection using acridinium ester label and paramagnetic particles; PMT optical system; 37°C reaction temperature; random access/batch processing; barcode-based sample/reagent tracking; Unix-based software; bi-directional LIS interface; dimensions/form factor: floor-standing analyzer.

Indications for Use

Indicated for in vitro diagnostic immunochemical analysis of clinical specimens (serum or plasma) for endocrine, anemia, allergy, reproductive, cardiovascular, oncology, adrenal, bone metabolism, therapeutic drug, and infectious disease markers. For prescription use only.

Regulatory Classification

Identification

The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.

Special Controls

*Classification.* Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”

Predicate Devices

• ACS: Centaur Analyzer (K971418)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ADVIA® Centaur

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _ KO32525

### 1. Intended Use

The Bayer ADVIA Centaur assay is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include endocrine, anemia, allergy, reproductive, cardiovascular, oncology, adrenal, bone metabolism, therapeutic drug, and infectious disease assays. All assays are based on chemiluminescent technology.

### 2. Predicate Device

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 510(k) Number: K971418

#### 3. Device Information

Proprietary Name: Bayer ADVIA Centaur Analyzer Common name: Automated Immunoassay Analyzer Classification name: Photometric Analyzer for Clinical Use Classification number: 21 CFR 862.2160, Class I

### 4. Device Description

The ADVIA 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 wastes
- Measures photon emissions .
- Performs data reduction
- Collects and maintains patient demographics and results ●

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# 5. Summary of Technological Characteristics

Assays that are dedicated for use on the ADVIA Centaur utilize acridinium ester as label and paramagnetic particles as the solid phase. The ADVIA Centaur measures the amount of light emitted during the chemiluminescent reaction. There is a direct relationship between the amount of light emitted and the amount of antigen in the patient sample. The system will measure both competitive binding assays and sandwich assays.

The ADVIA Centaur system uses a Master Curve and a two-point, user-initiated calibration to calibrate all the assays. The 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.

| Feature | ACS Centaur V1.0 | ADVIA Centaur V2.5 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| | (ACS Next Generation ) | |
| Principles of<br>Operation | - Chemiluminescence using magnetic-<br>particle solid phase and<br>chemiluminescent label | same |
| Optical System | - PMT used in photon counting mode | same |
| Temp control | - Reactions are controlled at 37°C | same |
| | - Reagent Storage:<br>- Reagents stored at 4°C to 8°C | same |
| Dispense System | - Automated pipetting of samples and<br>reagents<br>- Precision syringes (sample and<br>reagent) | same |
| | Sample Probe :<br>- Air pressure fluid sensing<br>- Air pressure disposable tip<br>sensing<br>- Clog detection mechanism to<br>alert operator to clogged sample probe | same |
| | Reagent Probes:<br>- No level sense; probe sent to<br>bottom of container<br>- Fluid monitoring during<br>aspiration | same |
| Reagent and Sample<br>Handling | - Samples: 5 tube racks hold sample<br>tube. The Sample Input, In-Process and<br>Output Queue holds up to 180 samples;<br>Tube size selected on sample tube rack<br>using an encoded barcode | same |
| | - Assay Reagents: Reagent Tray with<br>30 positions; Refrigeration; Reagent<br>Pack contains both Solid Phase and<br>Tracer Reagent in separate wells | same |
| | - Ancillary Reagents: Reagent<br>Compartment with 15 positions;<br>Refrigeration | same |
| Test Processing | Random Access and Batch | same |
| | - Sample scheduling optimized for<br>throughput; Continuous Operation | same |
| Assay Protocols | - 7.5 minute incubation, single step | same |
| | - 20 minute incubation, single step | same |
| | - 7.5 - 20 minute incubation, two step | same |
| | - 20 - 20 minute incubation, two Step | same |
| Human Interface -<br>data Output | - 17" Color Monitor with Graphical<br>User Interface | same |
| | - External printers | same |
| | - Serial bi-directional LIS Interface | same |
| | - Audible (adjustable) beeper | same |
| | - Computer LIS Interface | same |
| | - External Modem for Remote<br>Diagnostics Interface | same |
| Human Interface -<br>data Input | - 101 key keyboard | same |
| | - Hand-held barcode reader | same |
| | - Stationary barcode scanners for id of<br>patient samples | same |
| | - Moving Barcode reader for primary<br>reagents | same |
| | - Computer LIS Interface | same<br>LIS Software, additional features |
| Human Interface -<br>data analysis | - Automated data reduction | same |
| | - Assay-specific data reduction | same |
| QC Software | - Stored control results | same |
| | - L-J plotting | same |
| | - Statistical enhancements | same |
| | - Compatibility with CCD QC<br>Reporting | same<br>Added New Features to QC Functionality |
| Specimens | - Serum or plasma, sample cups or<br>primary tubes may be used | same |
| | - Dilutions allowed on a per-assay basis | same |
| | - Capability of Dilution of Samples<br>Requiring Pretreatment | same |
| Disposables | - Sample cups | same |
| | - Reaction cuvettes | same |
| | - Cuvette loading and unloading<br>allowed during run | same |
| | - Reagent I & 2 status tracked and<br>displayed | same |
| | - Time to First Result: 15 min., 30 min., 60 min. depending upon assay protocol | same |
| | . On-board supplies for 1000 tests (cuvettes,water,waste capacity) | same |
| | | Added diagnostic tools |
| Software | Unix based graphical User interface, Multiple distributed real-time computing platforms with capabilities to communicate to LIS and LAS systems. | Same, except for additional features as follows: |
| | | New Reports-maintenance,event log, reagent tracking. |
| | | Screen Saver added |
| | | New Exit queue status window |
| Hardware<br>Improvements | ACS Centaur System | Same, except for enhancements as follows: |
| | | New UI Module with increased capacity |
| | | Hitachi/ Unviersal rack option added |
| | | High Resolution Barcode Scanner (LS4000i) released |

A comparison table of Technological Features is included below:

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Andres Holle

Top Holle
Regular Corporation
Beger Corporation
S11 Bergorators
S11 Benedicot Avenue
Tarrytown, New York 10591-5097

8/8/03
Date

Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591-5097

SEP - 9 2003

k032525 Trade/Device Name: ADVIA® Centaur Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC; LOQ; MOI; NIG; LTK; DHK; KLT; JHX; JFT; JIT; LFM; KXT; CHP; DBF; CGN; JJX; CEC; CGJ; LCD; LPS; CEP; DDR; DIS; LGR; JLS: CFT: LTJ; LFX; LGD; MMI; KHQ; GWG; JHI; CDZ; LGS; DGC; JLW; JZO; LEH; DKB; CDD; JJE Dated: July 23, 2003 Received: August 15, 2003

Dear Mr. Holle:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Staven

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number:

Device Name: ADVIA® Centaur

Indications for Use:

The Bayer ADVIA Centaur is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include endocrine, anemia, allergy, reproductive, cardiovascular, oncology, adrenal, bone metabolism, therapeutic drug, and infectious disease assays. All assays are based on chemiluminescent technology.

Carol C. Bensen for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k 032525

(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-CounterUse

(Optional Format 1-2-96)