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 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 .

AI/ML Overview

The provided text describes a 510(k) summary for the ADVIA® Centaur automated immunoassay analyzer. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as would be found for a new diagnostic device or algorithm.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement is not available within this 510(k) summary. The document highlights the technological characteristics of the device and compares them to its predicate.

Here's an analysis of the provided text based on your request:

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

This document does not provide a table of acceptance criteria and reported device performance in the way typically expected for a clinical performance study. The 510(k) summary focuses on demonstrating substantial equivalence based on technological characteristics and intended use to a predicate device (ADVIA Centaur V2.5). The performance implied is that the new version (V3.0) performs equivalently to the predicate.

The table in the document compares "Features" of ADVIA Centaur V2.5 (K032525) and ADVIA Centaur V3.0. For almost all features, the entry for V3.0 is "same", implying that the performance related to these features is considered equivalent to the predicate. The only differences mentioned are software enhancements and hardware improvements.

Feature Type	Acceptance Criteria (Implied for V3.0)	Reported Device Performance (ADVIA Centaur V3.0)
Principles of Operation	Must be same as predicate (Chemiluminescence, magnetic-particle solid phase, chemiluminescent label)	Same as predicate
Optical System	Must be same as predicate (PMT in photon counting mode)	Same as predicate
Temp control	Must be same as predicate (Reactions at 37°C, reagents at 4°C-8°C)	Same as predicate
Dispense System	Must be same as predicate (Automated pipetting, precision syringes)	Same as predicate
Sample Probe	Must be same as predicate (Air pressure fluid/tip sensing, clog detection)	Same as predicate
Reagent Probes	Must be same as predicate (No level sense, fluid monitoring)	Same as predicate
Reagent and Sample Handling	Must be same as predicate (5 tube racks, 180 samples, 30 reagent positions, refrigeration)	Same as predicate
Test Processing	Must be same as predicate (Random Access and Batch, continuous operation, throughput optimization)	Same as predicate
Assay Protocols	Must be same as predicate (Various incubation times and steps)	Same as predicate
Human Interface - Data Output	Must be same as predicate (17" monitor, external printers, LIS, beeper, remote diagnostics)	Same as predicate
Human Interface - Data Input	Must be same as predicate (Keyboard, barcode readers, LIS)	Same as predicate
Human Interface - Data Analysis	Must be same as predicate (Automated data reduction)	Same as predicate
QC Software	Must be same as predicate (Assay-specific data reduction, stored controls, L-J plotting, statistical enhancements, CCD compatibility)	Same as predicate, with added "New Features to QC Functionality"
Specimens	Must be same as predicate (Serum/plasma, dilutions allowed)	Same as predicate
Disposables	Must be same as predicate (Sample cups, reaction cuvettes, pipette tips, loaded during run)	Same as predicate
Reagents	Must be same as predicate (Solid phase, Acridinium Ester, volume reporting, inventory tracking)	Same as predicate
Calibrators	Must be same as predicate (6-10 point stored, 2-point user, barcode check, lot number storage)	Same as predicate
Controls	Must be same as predicate (Low/mid/high, capability to dilute)	Same as predicate
Physical	Must be same as predicate (Size, weight, power, ambient temp)	Same as predicate
Laboratory Automation	Must be same as predicate (Software signals for direct sampling from transport system)	Same as predicate
Other User Interface Features	Must be same as predicate (Stat interrupt, auto cleaning, GUI, system status, foreign languages, multiple barcode formats, on-line help, system test extended)	Same as predicate (with extended system test including slope, offset, dilution, overrange)
Other Performance Features	Must be same as predicate (Throughput: 120-240 tests/hr, Time to First Result: 15-60 min, On-board supplies for 1000 tests)	Same as predicate
Software	Unix-based GUI, multiple distributed real-time computing platforms, LIS/LAS communication	Same as predicate, plus "Control Bracketing Software", "Restricted Test Mode", "Transmission of Ratio Component", "Repeat with Replicates", "New Reports"
Hardware Improvements	Hitachi/Universal rack option, High Resolution Barcode Scanner (LS4000i)	Same as predicate (these were present in the predicate V2.5 as well, indicating they were features of K032525)

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

This information is not available in the provided 510(k) summary. 510(k) submissions for automated analyzers like this typically focus on technical specifications and functional equivalence rather than clinical performance studies with specific patient sample test sets unless there's a novel assay or a significant change to existing assays. The comparison is feature-based against the predicate device.

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)

This information is not applicable/available. The document does not describe a clinical study requiring ground truth establishment by experts for a test set. This is a submission for an automated immunoassay analyzer, not an imaging device or diagnostic algorithm that relies on expert interpretation of results for ground truth.

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

This information is not applicable/available. There is no described test set or clinical study requiring adjudication.

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

This information is not applicable. The device is an automated immunoassay analyzer, not an AI-assisted diagnostic tool that involves human readers or interpretation of cases.

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

The ADVIA® Centaur system is inherently a standalone automated analyzer. Its performance is measured by its ability to accurately and precisely execute immunoassay analysis. The document implicitly supports this by stating it "performs the following functions" (aspirates, dispenses, adds reagents, incubates, separates, measures photon emissions, performs data reduction, collects and maintains data). The comparison to the predicate focuses on its ability to perform these functions similarly ("same").

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

This information is not applicable/available for the device itself in this context. For immunoassay analyzers, "ground truth" typically refers to the known concentrations of analytes in reference materials (calibrators, controls) or validated reference methods for patient samples, which are used to establish accuracy, precision, and linearity of the assays run on the system. The 510(k) summary does not detail the validation studies for specific assays run on the Centaur. It only states the system uses a "Master Curve and a two-point, user-initiated calibration."

8. The sample size for the training set

This information is not applicable/available. This 510(k) submission is for an updated version of an automated immunoassay analyzer, not an AI/ML device that requires a "training set" in the computational sense.

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

This information is not applicable/available for the same reason as point 8.

Summary

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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

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(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- Reagent Storage:- Reagents stored at 4°C to 8°C	same
Dispense System	- Automated pipetting of samples and reagents- Precision syringes (sample and reagent)	same
Sample Probe :	- Air pressure fluid sensing- Air pressure disposable tip sensing- Clog detection mechanism to alert operator to clogged sample probe	same
Reagent Probes:	- No level sense; probe sent to bottom of container- 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.- 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- 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- 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 InterfaceFeatures	- 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 PerformanceFeatures	- 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(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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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)

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

Page 1 of _1

Regulation Number and Section

§ 862.1810 Vitamin B

12 test system.(a)
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.(b)
Classification. Class II.