(273 days)
Not Found
No
The summary describes a standard immunoassay for TSH measurement and does not mention any AI or ML components in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is for in vitro diagnostic use, specifically for quantitative determination of thyroid-stimulating hormone (TSH) in serum to diagnose thyroid or pituitary disorders. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use" and that measurements are "used in the diagnosis of thyroid or pituitary disorders."
No
The device is an in vitro diagnostic assay that utilizes reagents and is performed on specific hardware systems (ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use".
- Measurement of Biomarkers: The device is designed to quantitatively determine thyroid-stimulating hormone (TSH) in serum, which is a biological sample taken from the body.
- Diagnosis of Disorders: The intended use also states that the measurements are used in the "diagnosis of thyroid or pituitary disorders". This is a key characteristic of an IVD.
- Device Description: The description details an immunoassay performed on biological samples (serum) to measure a specific analyte (TSH).
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in serum using the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
Product codes
JLW
Device Description
Not Found
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
The performance of the ADVIA Centaur TSH assay using the ADVIA Centaur XPT system was verified to ensure equivalent performance when used on the predicate ADVIA Centaur XP system. All verification testing met pre-determined acceptance criteria. Therefore, the introduction of the ADVIA Centaur XPT system does not negatively impact the performance, safety or effectiveness of the ADVIA Centaur TSH assay.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.
0
Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SIEMENS HEALTHCARE DIAGNOSTICS INC. ALEX HSU REGULATORY AND CLINICAL AFFAIRS SPECIALIST 511 BENEDICT AVE. TARRYTOWN NY 10591
April 22, 2015
Re: K141999
Trade/Device Name: ADVIA Centaur TSH Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: II Product Code: JLW Dated: March 25, 2015 Received: March 26, 2015
Dear Alex Hsu:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For: Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141999
Device Name ADVIA Centaur TSH
Indications for Use (Describe)
For in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in serum using the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990.
The assigned 510(k) Number is: K141999
Date Prepared 1.
April 21, 2015
2. Applicant Information
| Contact: | Alex Hsu
Regulatory and Clinical Affairs Specialist |
|----------|-----------------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591-5097 |
| Phone: | 914-524-3097 |
| Fax: | 914-524-3579 |
| Email: | alex.hsu@siemens.com |
Regulatory Information 3.
Table 1. Regulatory Information for ADVIA Centaur TSH Assay
| Trade Name | ADVIA Centaur ® TSH |
|---|---|
| Model Numbers | 08700387 (5-pack); 04911359 (1-pack) |
| Common Name | Radioimmunoassay, thyroid-stimulating hormone |
| Classification Name | Thyroid stimulating hormone test system |
| FDA Classification | Class II |
| Review Panel | Clinical Chemistry (75) |
| Product Code | JLW |
| Regulation Number | 862.1690 |
Predicate Device Information 4.
The ADVIA Centaur TSH assay was originally cleared by the FDA on 04/30/1991 (K910981) as the ACS TSH Immunoassay.
5. Description of Device Modifications
No changes were made to the ADVIA Centaur TSH assay reagents, calibrators or master curve value assignment in order to run on the ADVIA Centaur XPT.
Previously, the lower limit of detection was based on analytical sensitivity, whereas it is now based on Limit of Quantitation (LoQ). As result, the lower limit of detection has been revised from 0.01 µIU/mL to 0.05 µIU/mL. Accordingly, the analytical measuring range was also modified from 0.01-150 ulU/mL to 0.05-150 µlU/mL.
4
| Item | ADVIA Centaur TSH
(Unmodified Predicate Device) | ADVIA Centaur TSH
(Modified Candidate Device) |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Platforms | ADVIA Centaur
ADVIA Centaur XP | ADVIA Centaur
ADVIA Centaur XP
ADVIA Centaur XPT |
| Intended Use | For in vitro diagnostic use in the
quantitative determination of
thyroid-stimulating hormone (TSH,
thyrotropin) in serum using the
ADVIA Centaur and ADVIA
Centaur XP systems. | For in vitro diagnostic use in the
quantitative determination of
thyroid-stimulating hormone (TSH,
thyrotropin) in serum using the
ADVIA Centaur, ADVIA Centaur
XP and ADVIA Centaur XPT
systems. Measurements of thyroid
stimulating hormone produced by
the anterior pituitary are used in the
diagnosis of thyroid or pituitary
disorders. |
| Lower Limit of
Detection | 0.01 µIU/mL
Based on Analytical Sensitivity | 0.05 µIU/mL
Based on Limit of Quantitation |
| Expected Values | Includes reference ranges for:
Euthyroid
Hyperthyroid
Hypothyroid | Includes reference ranges for:
Euthyroid |
Table 2. List of Assay Modifications
Table 3. List of Instrument Modifications
| Item | ADVIA Centaur XP | ADVIA Centaur XPT |
|---|---|---|
| User Interface | ||
| CPU | Sun Sparc based CPU running | |
| Solaris (UNIX based ) OS, with | ||
| additional Intel based Application | ||
| PC (APC) for QC, online | ||
| documentation running on | ||
| Windows XP | Single Intel Quad processor based | |
| PC, with a new User Interface | ||
| application with integrated APC | ||
| applications running on Windows 7 | ||
| Real Time Control | ||
| CPU | Sun Sparc based CPU running | |
| Solaris (UNIX based ) OS for | ||
| instrument control and data | ||
| collection and analysis; | Real Time application rewritten to | |
| run on a RoHS compliant ARM 9 | ||
| based CPU running Nucleus OS; | ||
| Microcontrollers | Multiple distributed real-time | |
| Microcontrollers | Same (now RoHS compliant) | |
| QC Software | ADVIA QC application providing | |
| Stored control results, Levy- | ||
| Jennings plotting, and statistics, | ||
| integrated on the Application PC | ||
| (APC) within the product | ADVIA QC application now | |
| integrated into the UI application | ||
| Display Monitor | 19" LCD Touch Screen color | |
| monitor with Graphical User | ||
| Interface; | 22" LCD Touch Screen Color | |
| monitor supporting a resolution of | ||
| 1680 x 1050 with Graphical User | ||
| Interface |
5
| Item | ADVIA Centaur XP | ADVIA Centaur XPT |
|---|---|---|
| External Printer | No network capable printer | Support for new high speed and |
| networked printers | ||
| Remote Diagnostics | External Modem for Remote | |
| Diagnostics Interface and | ||
| application Software for remote | ||
| diagnostics over the Internet via | ||
| Server hosted on a separate | ||
| Application PC (APC) within the | ||
| product; | Same functionality integrated into | |
| the UI application | ||
| Barcode Reader | Stationary and handheld barcode | |
| scanners for identification of patient | ||
| samples |
Multiple barcode formats supported
including 128, 2 of 5, Code39,
Codabar; | Same plus added support for 2D
barcodes |
| Data Archival | Data Management, instrument data
can be archived to floppy disks or
CD | System supports DVDs & memory
sticks |
| Cleaning Procedures | Monthly cleaning procedures | Monthly cleaning has been
eliminated |
| Mounting of Reagent
Compartment
Refrigeration
Hardware | Reagent compartment mounted at
the left side of the instrument.
Thermo-electric devices for
refrigeration oriented in various
directions. | Same physical location of reagent
compartment.
Thermo-electric devices for
refrigeration oriented in uniform
direction. |
Table 3. List of Instrument Modifications
6
Comparison of Similarities and Differences between the 6. Predicate Device and the Candidate Device
| Item | ADVIA Centaur TSH
(Unmodified Predicate Device) | ADVIA Centaur TSH
(Modified Candidate Device) |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Instrument
Platforms | ADVIA Centaur
ADVIA Centaur XP | ADVIA Centaur
ADVIA Centaur XP
ADVIA Centaur XPT |
| Intended Use | For in vitro diagnostic use in the
quantitative determination of thyroid-
stimulating hormone (TSH,
thyrotropin) in serum using the ADVIA
Centaur and ADVIA Centaur XP
systems. | For in vitro diagnostic use in the
quantitative determination of
thyroid-stimulating hormone (TSH,
thyrotropin) in serum using the
ADVIA Centaur, ADVIA Centaur
XP and ADVIA Centaur XPT
systems. Measurements of thyroid
stimulating hormone produced by
the anterior pituitary are used in the
diagnosis of thyroid or pituitary
disorders. |
| Methodology | Two-site sandwich immunoassay
using direct chemiluminometric
technology | Same |
| Reagents | ReadyPack Primary Reagent Pack
contains both Solid Phase and Lite
Reagent in separate wells | Same |
| Lite Reagent | Monoclonal mouse anti-TSH antibody
labeled with
acridinium ester | Same |
| Solid Phase | Polyclonal sheep anti-TSH antibody
covalently coupled to paramagnetic
particles | Same |
| Specimen Type | Serum | Same |
| Sample Volume | 200 µL | Same |
| Calibration | 2-point calibration
using Calibrator B | Same |
| Lower Limit of
Detection | 0.01 µIU/mL
Based on Analytical Sensitivity | 0.05 µIU/mL
Based on Limit of Quantitation |
| Expected Values | Includes reference ranges for:
Euthyroid
Hyperthyroid
Hypothyroid | Includes reference ranges for:
Euthyroid |
| Item | ADVIA Centaur XP | ADVIA Centaur XPT |
| Principles of
Operation | Chemiluminescence using magnetic-
particle Solid Phase and
chemiluminescent label (acridinium
ester) Lite Reagent | Same |
| Optical System | Photo Multiplier Tube (PMT) used in
photon counting mode | Same |
| Temperature
Control | Reactions are controlled at 37°C
Reagents stored at 4°C to 8°C | Same |
| Cleaning
Procedures | Monthly cleaning procedures | Monthly cleaning has been
eliminated |
| Mounting of
Reagent
Compartment | Reagent compartment mounted at the
left side of the instrument. | Same physical location of reagent
compartment. |
| Refrigeration
Hardware | Thermo-electric devices for
refrigeration oriented in various
directions. | Thermo-electric devices for
refrigeration oriented in uniform
direction. |
| Test Processing | Random Access and Batch;
Cuvettes are incubated in a circular,
insulated track (Incubation Ring) that
advances the cuvette at 15 second
intervals and incubates the cuvette at
37°C. The incubation ring moves the
cuvettes from the sample probe to the
ancillary and reagent probes. | Same |
| Assay Protocols | Assay specific parameters contained in
Test Definitions (TDefs) for each
assay.
7.5 min incubation, single step; or
20 min incubation, single step;or
7.5 min / 20 min incubation, 2-step; or
20 min / 20 min incubation, 2-step | Same |
| Specimens | Serum or plasma;
Sample cups or primary tubes;
Dilutions allowed on a per-assay basis;
Capability of diluting samples requiring
pretreatment | Same |
| Disposables | Reaction cuvettes;
Sample Pipette Tips | Same |
| Calibration | 2 point user run calibration;
6 to 10 point stored calibration for each
reagent;
Calibrators checked with barcode;
Calibrator lot numbers stored and
displayed | Same |
Table 4. Similarities/Differences: Unmodified and Modified ADVIA Centaur TSH Assays
7
8
| ltem | ADVIA Centaur XP | ADVIA Centaur XPT |
|---|---|---|
| Throughput | 120 to 240 tests/hr | Same |
| Time to First | ||
| Result | 15 min, 30 min, 60 min depending | |
| upon assay protocol | Same | |
| Dimensions | Floor Model, 60H x 42D x 58L | |
| 1200 lbs | Same | |
| User Interface | ||
| CPU | Sun Sparc based CPU running Solaris | |
| (UNIX based ) OS, with additional Intel | ||
| based Application PC (APC) for QC, | ||
| online documentation running on | ||
| Windows XP | Single Intel Quad processor based | |
| PC, with a new User Interface | ||
| application with integrated APC | ||
| applications running on Windows 7 | ||
| Real Time Control | ||
| CPU | Sun Sparc based CPU running Solaris | |
| (UNIX based ) OS for instrument | ||
| control and data collection and | ||
| analysis; | Real Time application rewritten to | |
| run on a RoHS compliant ARM 9 | ||
| based CPU running Nucleus OS; | ||
| Microcontrollers | Multiple distributed real-time | |
| Microcontrollers | Same (now RoHS compliant) | |
| QC Software | ADVIA QC application providing | |
| Stored control results, Levy-Jennings | ||
| plotting, and statistics, integrated on | ||
| the Application PC (APC) within the | ||
| product | ADVIA QC application now | |
| integrated into the UI application | ||
| Display Monitor | 19" LCD Touch Screen color monitor | |
| with Graphical User Interface; | 22" LCD Touch Screen Color | |
| monitor supporting a resolution of | ||
| 1680 x 1050 with Graphical User | ||
| Interface | ||
| External Printer | No network capable printer | Support for new high speed and |
| networked printers | ||
| Remote | ||
| Diagnostics | External Modem for Remote | |
| Diagnostics Interface and application | ||
| Software for remote diagnostics over | ||
| the Internet via Server hosted on a | ||
| separate Application PC (APC) within | ||
| the product; | Same functionality integrated into | |
| the UI application | ||
| Barcode Reader | Stationary and handheld barcode | |
| scanners for identification of patient | ||
| samples | ||
| Multiple barcode formats supported | ||
| including 128, 2 of 5, Code39, | ||
| Codabar; | Same plus added support for 2D | |
| barcodes | ||
| Data Archival | Data Management, instrument data | |
| can be archived to floppy disks or CD | System supports DVDs & memory | |
| sticks |
Table 5. Similarities/Differences: ADVIA Centaur XP and ADVIA Centaur XPT Instruments
9
7. Summary of Design Control Activities
Design control activities, as outlined in 21CFR 820.30, were completed for the ADVIA Centaur XPT system.
A risk analysis (Failure Modes and Event Analysis) was undertaken to assess risks of using the device. This evaluation followed the Siemens Healthcare Diagnostics procedure for risk analysis, which is based on ISO 14971:2007, Medical devices - Application of risk management to medical devices. The risk analysis concluded that all identified risks were properly mitigated and no unacceptable risks are present.
The performance of the ADVIA Centaur TSH assay using the ADVIA Centaur XPT system was verified to ensure equivalent performance when used on the predicate ADVIA Centaur XP system. All verification testing met pre-determined acceptance criteria. Therefore, the introduction of the ADVIA Centaur XPT system does not negatively impact the performance, safety or effectiveness of the ADVIA Centaur TSH assay.
Conclusions 8.
The performance of the ADVIA Centaur TSH assay on the ADVIA Centaur XPT system is substantially equivalent to the ADVIA Centaur TSH assay running on the currently-marketed predicate ADVIA Centaur XP system.
The ADVIA Centaur XPT system has the same operating principles, assay performance characteristics and intended use as the predicate device, the ADVIA Centaur XP system. The results of performance testing and verification activities demonstrate that the design modifications to the ADVIA Centaur XPT do not impact its safety or effectiveness and do not alter its performance claims.
Furthermore, there have been no changes to the intended use of the ADVIA Centaur TSH assay, other than to include the ADVIA Centaur XPT, as described in the labeling, or the fundamental scientific technology of the device.