MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER

K041133 · Bayer Healthcare, LLC · CDD · Jul 2, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041133
• Device Name: MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
• Applicant: Bayer Healthcare, LLC
• Product Code: CDD · Clinical Chemistry
• Decision Date: Jul 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

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.

Device Story

Bayer Advia Centaur Automated Chemiluminescence Analyzer; modification involves version 3.0 software enhancements. Device performs automated chemiluminescence assays for clinical chemistry analysis. System operates in clinical laboratory settings; used by laboratory technicians/personnel. Software updates address user needs and technological demands. Fundamental scientific technology remains unchanged from predicate. Output used by clinicians for diagnostic decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics, performance features, and software functionality against the predicate device.

Technological Characteristics

Automated immunoassay analyzer; chemiluminescence sensing principle using acridinium ester label and magnetic-particle solid phase. PMT optical system; 37°C incubation; automated pipetting with air-pressure fluid/tip sensing. Floor-standing unit (60Hx42Dx58L). Connectivity: Serial bi-directional LIS, LAS, and remote diagnostics. Software: Unix-based GUI, distributed real-time computing. Disposables: sample cups, reaction cuvettes, pipette tips.

Indications for Use

Indicated for in vitro diagnostic immunochemical analysis of clinical specimens (serum or plasma) to assist in the diagnosis and monitoring of endocrine, anemia, allergy, reproductive, cardiovascular, oncology, adrenal, bone metabolism, therapeutic drug, and infectious disease states.

Regulatory Classification

Identification

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Predicate Devices

• Bayer Advia Centaur Automated Chemiluminescence Analyzer (K032525)

Submission Summary (Full Text)

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# JUL - 2 2004

### 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: _ _ 0 4 11 3 3

#### 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: Bayer ADVIA 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: K032525

### 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 Assays that are areatedics 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 ligand 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 | ADVIA Centaur V2.5<br>(K032525) | ADVIA Centaur V3.0 |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Principles of Operation | - Chemiluminescence using magnetic-particle solid phase and chemiluminescent label | same |
| Optical System | - PMT used in photon counting mode | same |
| Temp control | - Reactions are controlled at 37°C<br>- Reagent Storage:<br>- Reagents stored at 4°C to 8°C | same |
| Dispense System | - Automated pipetting of samples and reagents<br>- Precision syringes (sample and reagent) | same |
| Sample Probe : | - Air pressure fluid sensing<br>- Air pressure disposable tip sensing<br>- Clog detection mechanism to alert operator to clogged sample probe | same |
| Reagent Probes: | - No level sense; probe sent to bottom of container<br>- Fluid monitoring during aspiration | same |
| Reagent and Sample Handling | - Samples: 5 tube racks hold sample tube. The Sample Input, In-Process and Output Queue holds up to 180 samples; Tube size selected on sample tube rack using an encoded barcode.<br>- Assay Reagents: Reagent Tray with 30 positions; Refrigeration; Reagent Pack contains both Solid Phase and Tracer Reagent in separate wells | same |
| Ancillary Reagents: Reagent Compartment with 15 positions; Refrigeration | same | |
| Test Processing | Random Access and Batch<br>- Sample scheduling optimized for 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 - data Output | - 17" Color Monitor with Graphical User Interface | same |
| | - External printers | same |
| | - Serial bi-directional LIS Interface | same |
| | - Audible (adjustable) beeper | same |
| | - Computer LIS Interface | same |
| | - External Modem for Remote Diagnostics Interface | same |
| Human Interface - data Input | - 101 key keyboard | same |
| | - Hand-held barcode reader | same |
| | - Stationary barcode scanners for id of patient samples | same |
| | - Moving Barcode reader for primary reagents | same |
| | - Computer LIS Interface | same |
| | - LIS Software Enhancements | same |
| Human Interface - data analysis | - Automated data reduction | same |
| QC Software | - Assay-specific data reduction | same |
| | - Stored control results | same |
| | - L-J plotting | same |
| | - Statistical enhancements | same |
| | - Compatibility with CCD QC Reporting | same |
| | - Added New Features to QC Functionality | same |
| Specimens | - Serum or plasma, sample cups or primary tubes may be used | same |
| | - Dilutions allowed on a per-assay basis | same |
| | - Capability of Dilution of Samples Requiring Pretreatment | same |
| Disposables | - Sample cups | same |
| | - Reaction cuvettes | same |
| | - Cuvette loading and unloading allowed during run | same |
| | - Reagent I & 2 status tracked and displayed | same |
| | - Additional wash solutions (status tracked and displayed) | same |
| | - Sample Pipette Tips | same |
| | - All disposables may be loaded during operation | same |
| | | |
| Reagents | - Solid Phase | same |
| | - Chemiluminescent label (Acridinium Ester) | same |
| | - Reagent volume reporting | same |
| | - Reagent inventory tracks bottle usage | same |
| | - Ancillary Reagents with inventory tracking and volume reporting | same |
| Calibrators | - 6 to 10 point stored calibration for each reagent | same |
| | - 2 point user run calibration | same |
| | - Calibrators checked with barcode<br>- Calibrator lot numbers stored and displayed | same |
| Controls | - Low, mid, and high constituent controls | same |
| | - Capability to dilute controls | same |
| Physical | - Floor Model-, 60Hx42Dx58L | same |
| | - 1200 Ibs. | same |
| | - <2000 watts | same |
| | - ambient temp 18-30C | same |
| Laboratory Automation | Software signals for direct sampling from the sample transport system. | same |
| Other User Interface<br>Features | - Stat interrupt capability | same |
| | - Automated system cleaning | same |
| | - Graphical User Interface for scheduling batch runs, report options, easy-to-use maintenance | same |
| | - Complete reporting of system status and logging of system events | same |
| | - Tracking on-board reagent usage | same |
| | - Support for foreign languages: French, Italian, German, and Spanish language availability | same |
| | - Multiple barcode formats supporting including, 128, 2 of 5,Code39,Codabar | same |
| | - On-Line Information System(help) | same |
| | - System test extended to include slope and offset, dilution and overrange condition | same |
| | | same |
| Other Performance<br>Features | - Throughput: 120 to 240 tests/hr | same |
| | - Time to First Result: 15 min., 30 min., 60 min. depending upon assay protocol | same |
| | . On-board supplies for 1000 tests<br>(cuvettes water waste capacity) | same |
| 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. | same |
| | | Control Bracketing Software |
| | | Restricted Test Mode |
| | | Transmission of Ratio Component |
| | | Repeat with Replicates |
| Hardware Improvements | Hitachi/ Unviersal rack option added | same |
| | High Resolution Barcode Scanner (LS4000i) released. | same |

A comparison table of Technological Features is included below:

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Carl Zehr

Andres Holle Regulatory Affairs
Bayer Corporation
511 Benedict Avenue
Tarrytown, New York 10591-5097

4/21/2004
Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Public Health Service

JUL - 2 2004

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

k041133 Re: Trade/Device Name: ADVIA® Centaur Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Regulatory Classi Caso Case of CDZ, CEC, CEP, CFT, CGJ, CGN, CHP, DBF, DDR, DGC, DHX, DIS, DKB, JFT, JHI, JHX, JJE, JJX, JKD, JLS, JLW, JZO, KHQ, KLT, KXT, LCD, LCR, LEH, LFM, LFX, LGD, LGR, LGS, LOQ, LPS, LTK, MMI, MOI, NBC, NIG Dated: June 7, 2004 Received: June 9, 2004

Dear Mr. Holle:

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 (QS) 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) I mis lotter will anow yours ough to constantial equivalence of your device to a legally premailed 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, rr you store 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 I ou may 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,

Sean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K041133

Device Name: ADVIA® Centaur

Indications For Use:

The Bayer ADVIA Centaur is an automated immunoassay analyzer designed to r ne Dayol 7 it vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include endocrine, anemia, allergy, Speciment: "The Cyclescular, oncology, adrenal, bone metabolism, therapeutic reproductive, ourdlovaler, exsays. All assays are based on chemiluminescent technology.

Prescription Use (Part 21 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benam
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041133

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