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 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 is a 510(k) Summary for the Bayer ADVIA Centaur, an automated immunoassay analyzer. This type of document focuses on establishing substantial equivalence to a predicate device based on technological characteristics and intended use, rather than conducting new clinical performance studies with acceptance criteria, ground truth, and expert evaluation as would be seen for novel diagnostic devices.

Therefore, the provided text does not contain the kind of detailed information requested for a clinical study proving a device meets acceptance criteria. Specifically, it lacks:

Explicit acceptance criteria: There is no table detailing specific performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet.
A "study" proving acceptance criteria: The document focuses on demonstrating that the ADVIA Centaur is technologically equivalent to its predicate (ACS Centaur V1.0), implying that its performance will be similar, but it does not present a standalone clinical study with an associated test set, ground truth, or expert review.
Sample size for test set, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or training set details. These are all elements of a clinical validation study, which is not presented here.

Based on the provided text, I can only provide the following, which is largely descriptive of the device and its predicate equivalence rather than a performance study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not include specific acceptance criteria with quantitative performance targets (e.g., sensitivity, specificity, accuracy, precision ranges, etc.) for the ADVIA Centaur beyond the general equivalence to the predicate device. The "performance" described is largely a comparison of technological features to the predicate, implying similar performance.

Feature	Predicate Device (ACS Centaur V1.0)	ADVIA Centaur V2.5 (Reported Performance/Characteristics)
Principles of Operation	Chemiluminescence using magnetic-particle solid phase and chemiluminescent label	Same
Optical System	PMT used in photon counting mode	Same
Temperature Control	Reactions are controlled at 37°C; Reagent Storage: 4°C to 8°C	Same
Dispense System	Automated pipetting of samples and reagents; Precision syringes; Sample Probe: Air pressure fluid sensing, Air pressure disposable tip sensing, Clog detection mechanism; Reagent Probes: No level sense, fluid monitoring during aspiration	Same
Reagent and Sample Handling	Samples: 5 tube racks, up to 180 samples; Tube size selected by barcode; Assay Reagents: Reagent Tray with 30 positions, Refrigeration, Pack contains Solid Phase and Tracer Reagent; 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 min, single step; 20 min, single step; 7.5-20 min, two step; 20-20 min, two step	Same
Human Interface - Data Output	17" Color Monitor with GUI; External printers; Serial bi-directional LIS Interface; Audible beeper; Computer LIS Interface; External Modem for Remote Diagnostics Interface	Same
Human Interface - Data Input	101 key keyboard; Hand-held barcode reader; Stationary barcode scanners for patient samples; Moving Barcode reader for primary reagents; Computer LIS Interface	Same, with "LIS Software, additional features" (e.g., enhanced LIS)
Human Interface - Data Analysis	Automated data reduction; Assay-specific data reduction	Same
QC Software	Stored control results; L-J plotting; Statistical enhancements; Compatibility with CCD QC Reporting	Same, with "Added New Features to QC Functionality" (e.g., likely enhanced, but specifics not detailed)
Specimens	Serum or plasma, sample cups or primary tubes; Dilutions allowed on a per-assay basis; Capability of Dilution of Samples Requiring Pretreatment	Same
Disposables	Sample cups; Reaction cuvettes; Cuvette loading/unloading during run; Reagent 1 & 2 status tracked/displayed; Time to First Result: 15, 30, 60 min (assay-dependent); On-board supplies for 1000 tests	Same
Additional Features	N/A	Added diagnostic tools
Software	Unix based GUI, Multiple distributed real-time computing platforms, LIS/LAS communication	Same, except for "additional features" including "New Reports-maintenance, event log, reagent tracking. Screen Saver added. New Exit queue status window."
Hardware Improvements	ACS Centaur System	Same, except for enhancements: "New UI Module with increased capacity. Hitachi/Universal rack option added. High Resolution Barcode Scanner (LS4000i) released."

2. Sample Size for Test Set and Data Provenance

Not applicable. The document describes a substantial equivalence submission, not a clinical performance study with a distinct "test set" in the context of diagnostic accuracy. The data provenance and sample sizes for any underlying validation studies that led to the predicate's original clearance or the ADVIA Centaur's internal verification are not detailed here.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This information pertains to a clinical validation study where ground truth is established by experts (e.g., radiologists, pathologists). The 510(k) summary focuses on comparing technical specifications.

4. Adjudication Method

Not applicable. This is relevant for expert-adjudicated ground truth in clinical studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study assesses how AI intervention affects human reader performance. The ADVIA Centaur is an automated immunoassay analyzer, not an AI-powered image analysis or diagnostic aid designed to assist human readers. It performs tests on its own.

6. Standalone Performance Study

Yes, implicitly. The very nature of an automated immunoassay analyzer means it operates in a standalone fashion, providing results without direct human intervention in the analytical process. Its "performance" is demonstrated by its technical specifications and equivalence to the predicate, which implies its ability to accurately measure analytes in samples independently. However, specific standalone quantitative performance metrics (e.g., analytical sensitivity, specificity, imprecision, accuracy against a reference method) are not detailed in this summary; they would be found in detailed validation reports or product labeling.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied in AI/diagnostic imaging studies (e.g., pathology, outcomes data, expert consensus) is not directly applicable here. For an immunoassay analyzer, the "ground truth" for its analytical performance would be established through:

Reference methods: Comparisons to established, highly accurate laboratory methods for measuring analytes.
Certified reference materials/standards: Testing samples with known, certified concentrations of the analytes.
Clinical correlation: Showing that results from the device correlate well with clinical diagnoses or patient outcomes, although this is more for clinical utility than analytical accuracy.

This 510(k) summary does not specify which of these were used, nor does it present the results of such studies.

8. Sample Size for the Training Set

Not applicable. This device is an immunoassay analyzer and does not utilize a "training set" in the machine learning sense. Its operation is based on established chemiluminescent technology and predefined assay protocols, not trainable AI models.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of this device.

Summary

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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 ofOperation	- Chemiluminescence using magnetic-particle solid phase andchemiluminescent label	same
Optical System	- PMT used in photon counting mode	same
Temp control	- Reactions are controlled at 37°C	same
	- Reagent Storage:- Reagents stored at 4°C to 8°C	same
Dispense System	- Automated pipetting of samples andreagents- Precision syringes (sample andreagent)	same
	Sample Probe :- Air pressure fluid sensing- Air pressure disposable tipsensing- Clog detection mechanism toalert operator to clogged sample probe	same
	Reagent Probes:- No level sense; probe sent tobottom of container- Fluid monitoring duringaspiration	same
Reagent and SampleHandling	- Samples: 5 tube racks hold sampletube. The Sample Input, In-Process andOutput Queue holds up to 180 samples;Tube size selected on sample tube rackusing an encoded barcode	same
	- Assay Reagents: Reagent Tray with30 positions; Refrigeration; ReagentPack contains both Solid Phase andTracer Reagent in separate wells	same
	- Ancillary Reagents: ReagentCompartment with 15 positions;Refrigeration	same
Test Processing	Random Access and Batch	same
	- Sample scheduling optimized forthroughput; 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 GraphicalUser Interface	same
	- External printers	same
	- Serial bi-directional LIS Interface	same
	- Audible (adjustable) beeper	same
	- Computer LIS Interface	same
	- External Modem for RemoteDiagnostics Interface	same
Human Interface -data Input	- 101 key keyboard	same
	- Hand-held barcode reader	same
	- Stationary barcode scanners for id ofpatient samples	same
	- Moving Barcode reader for primaryreagents	same
	- Computer LIS Interface	sameLIS Software, additional features
Human Interface -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 QCReporting	sameAdded New Features to QC Functionality
Specimens	- Serum or plasma, sample cups orprimary tubes may be used	same
	- Dilutions allowed on a per-assay basis	same
	- Capability of Dilution of SamplesRequiring Pretreatment	same
Disposables	- Sample cups	same
	- Reaction cuvettes	same
	- Cuvette loading and unloadingallowed during run	same
	- Reagent I & 2 status tracked anddisplayed	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
HardwareImprovements	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 (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 Division 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,

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:

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)

Over-The-CounterUse

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1117 B-type natriuretic peptide test system.

(a)
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.(b)
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.”