(169 days)
Not Found
No
The description focuses on automated sample handling, processing, and immunoassay analysis, with no mention of AI or ML algorithms for data interpretation, decision-making, or image analysis.
No.
A therapeutic device is used to treat or cure a disease or condition. This device is an immunoassay analyzer used for in vitro diagnostic purposes to measure Thyroxine in serum, which aids in the diagnosis and treatment of thyroid diseases, but it does not directly treat the patient.
Yes
The device is described as an "automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens," and its measurements are "used in the diagnosis and treatment of thyroid diseases," which clearly indicates a diagnostic purpose.
No
The device description clearly outlines physical hardware components including an immunoassay analyzer (ADVIA Centaur) and a laboratory automation system (StreamLAB Analytical Workcell) that perform physical functions like sample handling, processing, and analysis. While software is involved in communication and control, the core functionality relies on these hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The ADVIA Centaur with StreamLAB® Analytical Workcell is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens."
- Explicit Statement in Device Description: The "Device Description" section also states: "The ADVIA Centaur® is a continuous operation, immunochemistry analyzer designed to perform in vitro diagnostic testing on clinical specimens."
- Purpose of the Device: The device performs "in vitro diagnostic immunochemical assay analysis on clinical specimens" and the results are "used in the diagnosis and treatment of thyroid diseases." This aligns directly with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Clinical Specimens: The device operates on "clinical specimens," which are samples taken from patients (e.g., serum).
- Clinical Laboratory Setting: The "Intended User / Care Setting" is a "Clinical laboratory," which is where IVD testing is typically performed.
The StreamLAB component, while a laboratory automation system, is integrated with the ADVIA Centaur analyzer to facilitate the IVD testing process. The combined system is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
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.
Product codes
JJE, KLI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 Instrument
| or Method | 510(k) | Product Code |
|---|---|---|
| ADVIA Centaur® | K041133 | JJE |
| StreamLAB® | ||
| Analytical Workcell | K043546 | JJE |
| ADVIA Centaur® T4 | ||
| Assay | K905532 | CDX |
1
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 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.
2
5. Device Intended Use:
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.
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® with
StreamLAB® Analytical Workcell |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The 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. | 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. |
| Principles of
Operation | Chemiluminescence using magnetic-particle solid phase and
chemiluminescent label | |
| Optical System | Photomultiplier tube used in photon counting mode | |
| Sample
Containers | Sample cups or primary tubes | Sample cups* or primary tubes |
| Sample Loading | Load directly onto the Centaur | Load directly onto the Centaur and/or
load onto the StreamLAB |
| Sample
Preparation | Manually centrifuged samples | Manually centrifuged samples or
automatically centrifuged samples by
the StreamLAB. |
3
| Feature | Predicate device:
ADVIA Centaur®
(K041133) | Proposed device:
ADVIA Centaur® with
StreamLAB® Analytical Workcell |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manually decapped sample tubes | Manually decapped sample tubes | Manually decapped sample tubes or
automatically decapped tubes by
StreamLAB. |
| Sample
Identification of
Bar-coded Tubes | Tube bar code (identification) is
read by the Centaur. | Tube bar code (identification) is read
by the Centaur (when tubes are placed
directly on the Centaur);
or tube bar code read by StreamLAB
and communicated electronically to
the Centaur (when tubes are loaded
onto 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 |
| Laboratory
Automation | Centaur's software communicates with Lab Automation System via LAS
interface. Centaur performs direct sampling from tube on the track. | Centaur's software communicates with Lab Automation System via LAS
interface. Centaur performs direct sampling from tube on the track. |
| * Sample cups cannot be used on the StreamLAB. Sample cups must be loaded directly onto the
Centaur when connected to the StreamLAB. The StreamLAB does not impact Centaur's
capability 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.
| 1
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An a status and the same of
| I |
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| ---------------- |
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| ------------------------------------------------------------------------------------------------- |
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|
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:
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.
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