The ADVIA Centaur with StreamLAB® Analytical Workcell is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include assays based on chemiluminescent technology, such as Thyroxine, along with other various chemiluminescent assays that may be adaptable to the analyzer depending on the reagent used to induce the chemiluminescent reaction.

The ADVIA Centaur T4 assay is for in vitro diagnostic use in the quantitative determination of thyroxine (T4) in serum on the ADVIA Centaur and ADVIA Centaur XP systems. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Device Description

The ADVIA Centaur® is a continuous operation, immunochemistry analyzer designed to perform in vitro diagnostic testing on clinical specimens.

The StreamLAB® Analytical Workcell is a laboratory automation system (LAS) designed to automate sample handling and processing in the clinical laboratory.

The ADVIA Centaur® with StreamLAB® Analytical Workcell combines the features of both the analyzer and the laboratory automation system.

The StreamLAB routes samples to the Centaur analyzer based on test request information it (StreamLAB) receives from the Laboratory Information System (LIS) and the test map established for the Centaur analyzer. StreamLAB and Centaur communicate sample and analyzer status via Centaur's Laboratory Automation System (LAS) interface. Via its LIS interface, the Centaur analyzer interfaces separately with the hospital's LIS to receive its test instructions (test requests) and to report results for each sample. Centaur's test instructions and test results for each sample are not processed through the StreamLAB.

The StreamLAB performs the following pre and post-analytical functions.

Sample bar code identification (previously performed by the Centaur) .
. Sample transport and tracking
. Sample centrifugation (optional functionality)
. Sample de-capping (optional functionality)
Sample transport and tracking
Tube sealing (optional functionality) .

The Centaur continues to perform the following functions, when connected to the StreamLAB.

. All functions except reading the sample tube bar code. When Centaur is connected to StreamLAB, samples can be loaded directly onto Centaur and/or loaded onto StreamLAB and routed to Centaur. For samples loaded onto StreamLAB, StreamLAB reads the sample tube bar code (sample identification) and passes it electronically to Centaur via the LAS interface to Centaur.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

Device: ADVIA Centaur® with StreamLAB® Analytical Workcell

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical thresholds as typically seen in modern submissions. Instead, it relies on a "method comparison" study to demonstrate substantial equivalence to a predicate device. The performance is reported in terms of linear regression parameters (slope, intercept, correlation coefficient) comparing the new device to the predicate.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (ADVIA Centaur® T4 Assay)
Linear Regression - Slope	Implicit: Close to 1.0 (indicating agreement between devices)	1.01
Linear Regression - Intercept	Implicit: Close to 0.0 (indicating no systematic bias)	-0.03
Linear Regression - Correlation Coefficient (r)	Implicit: High, close to 1.0 (indicating strong linear relationship)	0.999

Note: The phrase "CANNO LAND IN COLOR AN CONSULER COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLECTION COLLECTIONAmerican and a com a com a proven a management and a pro-" and similar garbled text in the "Method Comparison" table suggests data corruption or OCR errors in the original document. Assuming the numerical values (1.01, -0.03, 0.999) correspond to slope, intercept, and correlation coefficient, these are presented as the "reported device performance."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the method comparison study. It only mentions that "Split-sample method comparison studies were conducted using the ADVIA Centaur® T4 Assay."

Sample Size: Not explicitly stated.
Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that samples were collected and then tested on both systems, but there is no indication of whether these were new prospective samples collected for the study or previously stored retrospective samples. Given the context of a 510(k) for an in vitro diagnostic, samples would typically be clinical specimens.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable to this submission. The device is an automated immunoassay analyzer for quantitative determination of Thyroxine (T4). The "ground truth" for such devices is established by comparing its measurements against a recognized reference method or a predicate device, as done in this "method comparison" study. There is no subjective interpretation by human experts involved in establishing the T4 values for the test set.

4. Adjudication Method for the Test Set

This section is not applicable to this submission. The "ground truth" (comparison values from the predicate device) for quantitative diagnostic devices like this is based on the analytical measurement of the predicate device, not on expert adjudication of subjective findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done.
This type of study is relevant for diagnostic devices where human readers interpret images or data, and AI assistance can potentially improve their performance. The ADVIA Centaur with StreamLAB Analytical Workcell is an automated analyzer that performs quantitative immunoassays, with no human interpretation component in the diagnostic process itself.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a form of standalone performance was demonstrated.
The "Method Comparison" study demonstrates the performance of the proposed device (ADVIA Centaur with StreamLAB) in performing T4 assays independently, against the predicate device (ADVIA Centaur) which also operates as an automated system. This comparison evaluates the algorithm's performance in generating the quantitative T4 results. There is no human-in-the-loop component in the T4 measurement process itself.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurements obtained from the predicate device, the ADVIA Centaur® (K041133) using the ADVIA Centaur® T4 Assay. The study compares the new device's quantitative T4 results directly to the established, legally marketed predicate device on the same split samples.

8. The Sample Size for the Training Set

The document does not provide information regarding a training set sample size. For in vitro diagnostic (IVD) devices like this, particularly for a 510(k) submission showing substantial equivalence, the focus is typically on analytical and clinical performance studies (like method comparison) rather than an AI/ML model's training phase. While the internal development of assays and instruments involves extensive calibration and validation, this is distinct from "training data" as understood in AI/ML contexts where a model learns from data.

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

As noted above, the document does not provide information about a specific "training set" or how its ground truth was established, as the submission focuses on demonstrating equivalence through direct method comparison rather than an AI/ML model's training process.

Summary

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510(k) Summary of Safety and Effectiveness ADVIA Centaur® with StreamLAB® Analytical Workccll

FEB 2 6 2009

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

082638 The assigned 510(k) number is: >>

1. Submitter's Contact Information and Date of Preparation

Submitter's Contact Information:

Siemens Healthcare Diagnostics Inc. P.O. Box 6101 Newark, DE 19714-6601 Attn: Yuk-Ting Lewis Tel: 302-631-7626

Date of Preparation:

February 25, 2009

2. Proprietary Device Name / FDA Classification Name

ADVIA Centaur® with StreamLAB® Analytical Workcell / Class I: Discrete photometric chemistry analyzer for clinical use (21CFR§862.2160), Product Code JJE

3. Identification of the Predicate Device

Predicate Instrumentor Method	510(k)	Product Code
ADVIA Centaur®	K041133	JJE
StreamLAB®Analytical Workcell	K043546	JJE
ADVIA Centaur® T4Assay	K905532	CDX

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4. Device Description(s):

The ADVIA Centaur® is a continuous operation, immunochemistry analyzer designed to perform in vitro diagnostic testing on clinical specimens.

The StreamLAB® Analytical Workcell is a laboratory automation system (LAS) designed to automate sample handling and processing in the clinical laboratory.

The ADVIA Centaur® with StreamLAB® Analytical Workcell combines the features of both the analyzer and the laboratory automation system.

The StreamLAB performs the following pre and post-analytical functions.

Sample bar code identification (previously performed by the Centaur) .
. Sample transport and tracking
. Sample centrifugation (optional functionality)
. Sample de-capping (optional functionality)
Sample transport and tracking �
Tube sealing (optional functionality) .

The Centaur continues to perform the following functions, when connected to the StreamLAB.

. All functions except reading the sample tube bar code. When Centaur is connected to StreamLAB, samples can be loaded directly onto Centaur and/or loaded onto StreamLAB and routed to Centaur. For samples loaded onto StreamLAB, StreamLAB reads the sample tube bar code (sample identification) and passes it electronically to Centaur via the LAS interface to Centaur.

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5. Device Intended Use:

Medical device to which cquivalence is claimed 6.

The ADVLA Centaur® with StreamLAB® Analytical Workcell is substantially equivalent to the ADVIA Centaur (K041133). The devices have same / similar design and modes of operation. The key features are summarized in the table.

Feature	Predicate device:ADVIA Centaur®(K041133)	Proposed device:ADVIA Centaur® withStreamLAB® Analytical Workcell
Intended Use	The ADVIA Centaur® is anautomated immunoassay analyzerdesigned to perform in vitrodiagnostic immunochemical assayanalysis on clinical specimens.The system menu will includeendocrine, anemia, allergy,reproductive, cardiovascular,oncology, adrenal, bonemetabolism, therapeutic drug, andinfectious disease assays. Allassays are based onchemiluminescent technology.	The ADVIA Centaur withStreamLAB® Analytical Workcell isan automated immunoassay analyzerdesigned to perform in vitro diagnosticimmunochemical assay analysis onclinical specimens. The system menuwill include assays based onchemiluminescent technology, such asThyroxine, along with other variouschemiluminescent assays that may beadaptable to the analyzer depending onthe reagent used to induce thechemiluminescent reaction.
Principles ofOperation	Chemiluminescence using magnetic-particle solid phase andchemiluminescent label
Optical System	Photomultiplier tube used in photon counting mode
SampleContainers	Sample cups or primary tubes	Sample cups* or primary tubes
Sample Loading	Load directly onto the Centaur	Load directly onto the Centaur and/orload onto the StreamLAB
SamplePreparation	Manually centrifuged samples	Manually centrifuged samples orautomatically centrifuged samples bythe StreamLAB.

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Feature	Predicate device:ADVIA Centaur®(K041133)	Proposed device:ADVIA Centaur® withStreamLAB® Analytical Workcell
Manually decapped sample tubes	Manually decapped sample tubes	Manually decapped sample tubes orautomatically decapped tubes byStreamLAB.
SampleIdentification ofBar-coded Tubes	Tube bar code (identification) isread by the Centaur.	Tube bar code (identification) is readby the Centaur (when tubes are placeddirectly on the Centaur);or tube bar code read by StreamLABand communicated electronically tothe Centaur (when tubes are loadedonto StreamLAB).
Test Orders	Unidirectional communication with external LIS	Unidirectional communication with external LIS
Test Results	Unidirectional communication with external LIS	Unidirectional communication with external LIS
LaboratoryAutomation	Centaur's software communicates with Lab Automation System via LASinterface. Centaur performs direct sampling from tube on the track.	Centaur's software communicates with Lab Automation System via LASinterface. Centaur performs direct sampling from tube on the track.
* Sample cups cannot be used on the StreamLAB. Sample cups must be loaded directly onto theCentaur when connected to the StreamLAB. The StreamLAB does not impact Centaur'scapability to accept sample cups.

Method Comparison

Split-sample method comparison studies were conducted using the ADVIA Centaur® T4 Assay. Samples were processed either directly on the predicate device or on the proposed device. The data were analyzed by linear regression and the results are summarized in the table below.

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1	CARD C. LILLER CLECK CLECK LE LEBERT BE LEE1-------------------------------------------------------------------------------------------------	1				CALL CLASS AND AND A BEEAn- 6 Par 1

7. Conclusion:

The proposed ADVIA Centaur® with StreamLAB® Analytical Workcell and the predicate ADVIA Centaur® (K041133) are substantially equivalent in design, modes of operation, assay performance and intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, clutching what appears to be a caduceus or similar symbol in its talons.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics Inc. c/o Yuk-Ting Lewis Regulatory Affairs & Compliance Manager P.O. Box 6101, Mailstop 514 Newark, DE 19714-6101

FEB 2 6 2009

Re: K082638

Trade/Device Name: ADVIA Centaur with StreamLAB Analytical Workcell using Thyroxine reagents

Regulation Number: 21CFR Sec.862.1700. Regulation Name: Total thyroxine test system Regulatory Class: Class II Product Code: KLI, JJE Dated: February 20, 2009 Received: February 23, 2009

Dear Ms. Lewis:

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) premarket notification. The FDA finding of substantial equivalence of your device to 1 legally marketed predicate device results in a classification for your device and thus, corrects 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-fire number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Corg C. Hh

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

120200000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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Indication for Use

510(k) Number (if known):

Device Name: ADVIA Centaur with StreamLAB® Analytical Workcell using Thyroxine reagents

Indications For Use:

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082638

Regulation Number and Section

§ 862.1700 Total thyroxine test system.

(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.