(72 days)
No
The summary describes a standard in vitro diagnostic assay for TSH and does not mention any AI/ML components or capabilities.
No
The device is for in vitro diagnostic use, meaning it's used to analyze samples from the body to diagnose conditions, not to treat them. Its intended use is the quantitative determination of TSH in serum and plasma, which is for diagnosis of thyroid or pituitary disorders, not for therapeutic intervention.
Yes
The device is described as being "for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in serum, heparinized plasma, and EDTA plasma" and for "Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders." This explicitly states its diagnostic purpose in the context of in vitro use for disease diagnosis.
No
The device is an in vitro diagnostic assay for use on a specific hardware system (ADVIA Centaur XP systems), indicating it is a reagent/assay kit and not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"For in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in serum, heparinized plasma, and EDTA plasma using the ADVIA Centaur XP systems."
This statement clearly indicates that the device is intended for use outside of the body (in vitro) to diagnose conditions.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in serum, heparinized plasma, and EDTA plasma using the ADVIA Centaur XP 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
Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders, including infants, children, and adolescents.
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 Insert) does not necessitate the collection of additional analytical performance data. Therefore, all analytical performance data previously reviewed for the ADVIA Centaur TSH3-Ultra assay continues to apply to this device. All performance data is cross-referenced to the original 510(k) submission (K083844) for this device.
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
§ 862.1690 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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SIEMENS HEALTHCARE DIAGNOSTICS, INC. MATTHEW GEE SENIOR MANAGER 511 BENEDICT AVENUE TARRYTOWN NY 10591
May 1, 2015
Re: K150403
Trade/Device Name: ADVIA Centaur® TSH3-Ultra Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: II Product Code: JLW Dated: February 16, 2015 Received: February 18, 2015
Dear Mr. Matthew 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 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
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Indications for Use
510(k) Number (if known) K150403
Device Name ADVIA Centaur® TSH3-Ultra
Indications for Use (Describe)
For in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in serum, heparinized plasma, and EDTA plasma using the ADVIA Centaur XP 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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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: K150403
Date Prepared 1.
April 24, 2015
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 |
3. Regulatory Information
Table 1. Regulatory Information for ADVIA Centaur TSH3-Ultra Assay
| Trade Name | ADVIA Centaur® TSH3-Ultra |
|---|---|
| Model Numbers | 06491072 (1-pack) and 06491080 (5-pack) |
| Common Name | Radioimmunoassay, thyroid-stimulating hormone |
| Classification Name | Thyroid stimulating hormone test system |
| Product Code | JLW |
| Regulation Number | 862.1690 |
| FDA Classification | Class II |
| Review Panel | Clinical Chemistry |
Predicate Device Information 4.
The update of pediatric reference intervals to the labeling (Package Insert) of the ADVIA Centaur TSH3-Ultra assay does not require any other device modifications (i.e. no change to design or manufacturing process). Therefore, the predicate device (K083844) and subject device are the same.
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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) with updated pediatric reference intervals.
| ltem | Predicate Device
(Unmodified Labeling) | Subject Device
(Updated Reference Intervals) |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analytes | thyroid stimulating hormone (TSH) | Same |
| Reagents | ADVIA Centaur TSH3-Ultra | Same |
| Instruments | ADVIA Centaur
ADVIA Centaur XP | Same |
| Intended Use
Statements | For in vitro diagnostic use in the
quantitative determination of thyroid-
stimulating hormone (TSH,
thyrotropin) in serum, heparinized
plasma, and EDTA plasma 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, heparinized
plasma, and EDTA plasma using the
ADVIA Centaur and ADVIA Centaur
XP systems. Measurements of
thyroid stimulating hormone
produced by the anterior pituitary are
used in the diagnosis of thyroid or
pituitary disorders. |
| Analytical
Measuring Range
(Assay Range) | 0.008 - 150 µlU/mL (mIU/L) | Same |
| Adult
Reference Interval | 0.55 - 4.78 mIU/L (mIU/L) | Same |
| Pediatric
Reference Intervals | Infants: None
Pediatrics: 02 years - 11 years
Adolescents: 12 years - 18 years | Infants: 01 month - 23 months
Children: 02 years - 12 years
Adolescents: 13 years - 20 years |
| Table 2. Summary of Substantial Equivalence for ADVIA Centaur Thyroid Assays | ||||
|---|---|---|---|---|
| ------------------------------------------------------------------------------ | -- | -- | -- | -- |
6. Standard/Guidance Document Reference
Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline -- Third Edition (CLSI EP28-A3c); FDA Recognition Number 7-224.
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Pediatric Reference Intervals 7.
Data from a total of 442 patients (94 infants. 198 children, 150 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.
| Infants (01 - 23M) | 0.87 – 6.15 μIU/mL (mIU/L) |
|---|---|
| Children (02 - 12Y) | 0.67 – 4.16 μIU/mL (mIU/L) |
| Adolescents (13 – 21Y) | 0.48 – 4.17 μIU/mL (mIU/L) |
| Euthyroid Adults* | 0.55 – 4.78 μIU/mL (mIU/L) |
| Assay Range* | 0.008 – 150 μIU/mL (mIU/L) |
- Information taken from existing Instructions for Use (Package Insert)
Performance Characteristics 8.
The inclusion of pediatric reference intervals in the Instructions for Use (Package Insert) does not necessitate the collection of additional analytical performance data. Therefore, all analytical performance data previously reviewed for the ADVIA Centaur TSH3-Ultra assay continues to apply to this device. All performance data is cross-referenced to the original 510(k) submission (K083844) for this device.
Specifically, the following studies are not needed for the purpose of this submission:
- I Precision/Reproducibility
- I Linearity
- I Calibrator/Assay Traceability
- I Calibrator/Assay Stability
- l Assay Cut-off
- Method Comparison
- I Matrix Comparison
- . Sensitivity (Detection Limits, LoB, LoD, LoQ)
- Analytical Specificity l
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Shelf-Life 9.
The inclusion of pediatric reference intervals in the Instructions for Use (Package Insert) does not necessitate the collection of additional stability data. Therefore, all stability methods, acceptance criteria and data previously reviewed for the ADVIA Centaur TSH3-Ultra assay continues to apply to this device. All stability information is cross-referenced to the original 510(k) submission (K083844) for this device.
Specifically, the following stability studies are not needed for the purpose of this submission:
- Shelf Life Stability
- Onboard Stability
- Open Vial Stability
10. Conclusions
The ADVIA Centaur TSH3-Ultra assay with updated pediatric reference intervals is substantially equivalent to the currently marketed ADVIA Centaur TSH3-Ultra assay.
The modification of pediatric reference intervals in the Instructions for Use (Package Insert) 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) submission for this assay (K083844).
The modification 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 (i.e. for use 1. in the diagnosis of thyroid or pituitary disorders), as described in 21 CFR §862.1690.
-
- The updated reference intervals for children and adolescents are similar to those previously presented in the Instructions for Use (Package Insert)
-
- The newly-established infant reference intervals are either within or are above the previously-established reference intervals for euthyroid (normal thyroid) adult and pediatric populations and they are within the analytical measuring ranges of the ADVIA Centaur TSH3-Ultra assay. Therefore, the ADVIA Centaur TSH3-Ultra assay has appropriate analytical performance to test infant patients.