(56 days)
No
The document describes an in vitro diagnostic assay for thyroid hormones using a standard laboratory analyzer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies and predicate devices are standard for this type of assay.
No.
The device is used for in-vitro diagnostic purposes to measure free thyroxine and thyroxine levels, which are used in the diagnosis and treatment of thyroid disease. It does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "For in vitro diagnostic use" and that its measurements "are used in the diagnosis and treatment of thyroid disease."
No
The device is an in vitro diagnostic assay used on specific hardware systems (ADVIA Centaur and ADVIA Centaur XP systems) for the quantitative determination of substances in serum or plasma. This indicates it is a reagent/assay kit used with hardware, not a standalone software device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "For in vitro diagnostic use" multiple times. It describes the device's purpose as the quantitative determination of substances (free thyroxine and thyroxine) in biological samples (serum or plasma) for the diagnosis and treatment of thyroid disease. This aligns perfectly 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 free thyroxine (FTA) in serum or plasma (heparinized or EDTA), using the ADVIA Centaur and ADVIA Centaur XP systems. Measurements of free thyroxine are used in the diagnosis and treatment of thyroid disease.
For in vitro diagnostic use in the quantitative determination of thyroxine (T4) in serum using the ADVIA Centaur and ADVIA Centaur XP systems. Measurements of thyroxine are used in the diagnosis and treatment of thyroid disease.
Product codes
CEC, KLI
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
Infants (01 – 23 months)
Children (02 – 12 years)
Adolescents (13 – 21 years)
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)
The inclusion of pediatric reference intervals in the Instructions for Use (Package Inserts) does not necessitate the collection of additional analytical performance data. Therefore, all analytical performance data previously reviewed for the ADVIA Centaur FT4 and T4 assays continues to apply to these assays. All performance data is cross-referenced to the original 510(k) submissions for the FT4 and T4 assays (K905532 and K080167) and subsequent submissions demonstrating performance of the assays on the ADVIA Centaur system (K971418).
Specifically, the following studies are not needed for the purpose of this submission:
- Precision/Reproducibility
- Linearity
- Calibrator/Assay Traceability
- Calibrator/Assay Stability
- Assay Cut-off
- Method Comparison
- Matrix Comparison
- Sensitivity (Detection Limits, LoB, LoD, LoQ)
- Analytical Specificity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1695 Free thyroxine test system.
(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness
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:
Date Prepared 1.
August 8, 2013
Applicant Information 2.
| Contact: | Matthew Gee, M.Sc.
Senior Manager, Regulatory Affairs | |
|--------------------|----------------------------------------------------------------------------------------|--|
| Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591-5097 | |
| Phone:914-524-2099 | | |
| Fax: | 914-524-3579 | |
| Email: | matthew.gee@siemens.com | |
SEP 1 3 2013
Regulatory Information 3.
Table 1. Regulatory Information for ADVIA Centaur FT4 and T4 Assays
| FT4 | T4 | |
|---|---|---|
| Trade Name | ADVIA Centaur® FT4 | ADVIA Centaur® T4 |
| Model Numbers | 06490106 (5-pack) | |
| 06490092 (1-pack) | 09236439 (5-pack) | |
| 08074354 (1-pack) | ||
| Common Name | Radioimmunoassay, | |
| free thyroxine | Enzyme immunoassay, | |
| non-radiolabeled, total thyroxine | ||
| Classification Name | Free thyroxine test system | Total thyroxine test system |
| FDA Classification | Class II | Class II |
| Review Panel | Clinical Chemistry | Clinical Chemistry |
| Product Code | CEC | KLI |
| Regulation Number | 862.1695 | 862.1700 |
4. Predicate Device Information
The inclusion of pediatric reference intervals to the labeling (Package Inserts) of the ADV/A Centaur FT4 and T4 assays does not require any other device modifications (i.e. no change to design or manufacturing process). Therefore, as shown in the table below, the predicate and subject devices are the same.
| Table 2. Summary of Predicate Devices for ADVIA Centaur FT4 and T4 Assays | |||||||
|---|---|---|---|---|---|---|---|
| FT4 | T4 | |
|---|---|---|
| Predicate Device | ADVIA Centaur® FT4 | ADVIA Centaur® T4 |
| Subject Device | Same (As above) | Same (As above) |
| Original 510(k) | K080167 | K905532 |
Siemens Healthcare Diagnostics Inc., Tarrytown, NY ADVIA Centaur Thyroid Assays Pediatric Reference Intervals
1
Substantial Equivalence Information 5.
The following table demonstrates substantial equivalence between the predicate ADVIA Centaur thyroid assays (with unmodified labeling) and ADVIA Centaur thyroid assays which have modified Instructions for Use (Package Inserts) including pediatric reference intervals.
| Item | Predicate Device
(Unmodified Labeling) | Subject Device
(With Pediatric Reference Intervals) |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analytes | free thyroxine (FT₄)
total thyroxine (T₄) | Same |
| Reagents | ADVIA Centaur FT4
ADVIA Centaur T4 | Same |
| Instruments | ADVIA Centaur
ADVIA Centaur XP | Same |
| Intended Use
Statements | ADVIA Centaur FT4
For in vitro diagnostic use in the
quantitative determination of free
thyroxine (FT₄) in serum or plasma
(heparinized or EDTA), using the
ADVIA Centaur and ADVIA Centaur
XP systems. Measurements of free
thyroxine are used in the diagnosis and
treatment of thyroid disease. | ADVIA Centaur FT4
Same |
| | ADVIA Centaur T4
For in vitro diagnostic use in the
quantitative determination of thyroxine
(T₄) in serum using the ADVIA Centaur
and ADVIA Centaur XP systems. | ADVIA Centaur T4
For in vitro diagnostic use in the
quantitative determination of thyroxine
(T₄) in serum using the ADVIA Centaur
and ADVIA Centaur XP systems.
Measurements of thyroxine are used in
the diagnosis and treatment of thyroid
disease. |
| Analytical
Measuring Range
(Assay Range) | ADVIA Centaur FT4
0.1 – 12 ng/dL (1.3 – 155 pmol/L) | ADVIA Centaur FT4
Same |
| | ADVIA Centaur T4
0.3 – 30 µg/dL (3.9 – 387 nmol/L) | ADVIA Centaur T4
Same |
| Adult
Reference Intervals | ADVIA Centaur FT4
Euthyroid, Hypothyroid, Hyperthyroid | ADVIA Centaur FT4
Same |
| | ADVIA Centaur T4
Apparently Healthy Individuals,
Hypothyroid, Hyperthyroid,
Pregnant Euthyroid, Sick Euthyroid | ADVIA Centaur T4
Same |
| Pediatric
Reference Intervals | None | Infants (01 – 23 months)
Children (02 – 12 years)
Adolescents (13 – 21 years) |
| Table 3. Summary of Substantial Equivalence for ADVIA Centaur Thyroid Assays | ||||
|---|---|---|---|---|
| -- | ------------------------------------------------------------------------------ | -- | -- | -- |
Standard/Guidance Document Reference 6.
Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline -- Third Edition (CLSI C28-A3c).
2
Pediatric Reference Intervals 7.
Data from a total of 454 patients (72 infants, 190 children, 129 adolescents) were analyzed to establish the ADVIA Centaur thyroid assay reference intervals for the studied pediatric population. These pediatric reference intervals, as well as the previously-established euthyroid adult reference intervals and analytical measuring ranges, are presented below.
| FT4 | T4 | |
|---|---|---|
| Infants (01 - 23M) | 0.94 – 1.44 ng/dL | 6.03 – 13.18 µg/dL |
| Children (02 - 12Y) | 0.86 – 1.40 ng/dL | 5.50 - 12.10 µg/dL |
| Adolescents (13 - 21Y) | 0.83 – 1.43 ng/dL | 5.50 - 11.10 µg/dL |
| Euthyroid Adults* | 0.89 – 1.76 ng/dL | 4.50 - 10.90 µg/dL |
| Assay Range* | 0.10 - 12.0 ng/dL | 0.30 - 30.00 µg/dL |
Table 4. Comparison of Pediatric and Adult 95% Reference Intervals
- Information taken from existing Instructions for Use (Package Inserts)
Performance Characteristics 8.
The inclusion of pediatric reference intervals in the Instructions for Use (Package Inserts) does not necessitate the collection of additional analytical performance data. Therefore, all analytical performance data previously reviewed for the ADVIA Centaur FT4 and T4 assays continues to apply to these assays. All performance data is cross-referenced to the original 510(k) submissions for the FT4 and T4 assays (K905532 and K080167) and subsequent submissions demonstrating performance of the assays on the ADVIA Centaur system (K971418).
Specifically, the following studies are not needed for the purpose of this submission:
- Precision/Reproducibility 트
- . Linearitv
- l Calibrator/Assay Traceability
- 요 Calibrator/Assay Stability
- 1 Assay Cut-off
- . Method Comparison
- . Matrix Comparison
- Sensitivity (Detection Limits, LoB, LoD, LoQ)
- 장 Analytical Specificity
Shelf-Life 9.
The inclusion of pediatric reference intervals in the Instructions for Use (Package Inserts) does not necessitate the collection of additional stability data. Therefore, all stability methods, acceptance criteria and data previously reviewed for the ADVIA Centaur FT4 and T4 assays continues to apply to these assays. All stability information is cross-referenced to the original 510(k) submissions for the FT4 and T4 assays (K905532 and K080167) and subsequent submissions demonstrating performance of the assays on the ADVIA Centaur system (K971418).
Specifically, the following stability studies are not needed for the purpose of this submission:
- Shelf Life Stabilitv ■
- Onboard Stability
- 8 Open Vial Stability
3
Conclusions 10.
The ADVIA Centaur FT4 and T4 assays with pediatric reference intervals are substantially equivalent to the currently marketed ADVIA Centaur FT4 and T4 assays.
The inclusion of pediatric reference intervals in the Instructions for Use (Package Inserts) does not require a change in the device design or a change in the manufacturing process.
All performance data is cross-referenced to the original 510(k) submissions for these assays (K905532 and K080167) and subsequent submissions demonstrating performance of the assays on the ADVIA Centaur system (K971418).
The addition of pediatric reference intervals for the ADVIA Centaur thyroid assays is further supported by the following rationale:
-
- Testing of pediatric patients is within the established indications for use in the diagnosis and treatment of thyroid disease), as described in 21 CFR §862.1695 and 21 CFR §862.1700.
-
- The newly-established pediatric reference intervals are either within or are above the previously-established reference intervals for euthyroid (normal thyroid) adult populations and they are within the analytical measuring ranges of the ADVIA Centaur FT4 and T4 assays. Therefore, the ADVIA Centaur FT4 and T4 assays have appropriate analytical performance to test pediatric patients.
4
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, with three wavy lines below it. The image is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Glob Silver Spring, MD 20993-0002
September 13, 2013
Siemens Healthcare Diagnostics, Inc. c/o Matthew Gee 511 Benedict Ave. TARRYTOWN NY 10591-5097
Re: K132249
Trade/Device Name: ADVIA Centaur® Ft4 ADVIA Centaur® T4 Regulation Number: 21 CFR 862.1695 Regulation Name: Free thyroxine test system Regulatory Class: II Product Code: CEC, KLI, Dated: August 9, 2013 Received: August 12, 2013
Dear Mr. Gee:
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 cither 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.
5
Page 2-Mr. Gee
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809). please contact the Division of Small Manufacturers, International and Consumer Assistance 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" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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,
Carol C. Benson -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
6
Indications for Use
510(k) Number (if known):
Device Name:
ADVIA Centaur® FT4 ADVIA Centaur® T4
Indications for Use:
For in vitro diagnostic use in the quantitative determination of free thyroxine (FTA) in serum or plasma (heparinized or EDTA), using the ADVIA Centaur and ADVIA Centaur XP systems. Measurements of free thyroxine are used in the diagnosis and treatment of thyroid disease.
For in vitro diagnostic use in the quantitative determination of thyroxine (T4) in serum using the ADVIA Centaur and ADVIA Centaur XP systems. Measurements of thyroxine are used in the diagnosis and treatment of thyroid disease.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung W. Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K132249 510(k)
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