(85 days)
Not Found
No
The summary describes an in vitro diagnostic assay for measuring TSH and free T4. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology. The performance studies focus on establishing reference intervals for pediatric populations, which is a standard clinical validation process, not indicative of AI/ML.
No.
The device is used for in vitro diagnostic testing to measure TSH and free T4 levels, which aids in the diagnosis and treatment of thyroid diseases, but it does not directly treat or provide therapy to patients.
Yes
The intended use explicitly states "For in vitro diagnostic use" and mentions "diagnosis of thyroid or pituitary disorders" and "diagnosis and treatment of thyroid disease."
No
The device is an in vitro diagnostic assay, which involves chemical reagents and hardware (the IMMULITE® 2000 Systems Analyzers) to perform the measurements. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers — for the quantitative measurement of thyrotropin (TSH) in serum."
- "For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers — for the quantitative measurement of non-protein-bound thyroxine (free T4) in serum and heparinized plasma."
This language clearly indicates that the device is intended for use in a laboratory setting to perform tests on biological samples (serum and plasma) to aid in the diagnosis of medical conditions (thyroid or pituitary disorders, thyroid disease). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers - for the quantitative measurement of thyrotropin (TSH) in serum. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers — for the quantitative measurement of nonprotein-bound thyroxine (free T4) in serum and heparinized plasma. Measurements of free thyroxine are used in the diagnosis and treatment of thyroid disease.
Product codes
JLW, CEC
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 – 20 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)
Free T4: Data from a total of 426 patients (81 infants, 197 children, 148 adolescents) tested with the IMMULITE 2000 Free T4 assay were analyzed to establish the reference intervals for the studied pediatric population.
Third Generation TSH: Data from a total of 433 patients (90 infants, 195 children, 148 adolescents) tested with the IMMULITE 2000 Third Generation TSH assay were analyzed to establish the reference intervals for the studied pediatic population.
The new pediatric reference intervals are within the analytical measuring capability of the assay.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other. The faces are simple and abstract, and they appear to be facing to the right.
May 31, 2016
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, REGULATORY AFFAIRS 511 BENEDICT AVENUE TARRYTOWN, NY 10591
Re: K160647
Trade/Device Name: IMMULITE 2000 Third Generation TSH IMMULITE 2000 Free T4 Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: II Product Code: JLW. CEC Dated: March 4, 2016 Received: March 7, 2016
Dear 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
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (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 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 vours.
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name IMMULITE® 2000 Third Generation TSH IMMULITE® 2000 Free T4
Indications for Use (Describe)
For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers - for the quantitative measurement of thyrotropin (TSH) in serum. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers — for the quantitative measurement of nonprotein-bound thyroxine (free T4) in serum and heparinized plasma. Measurements of free thyroxine are used in the diagnosis and treatment of thyroid disease.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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: K160647
Date Prepared 1.
May 3, 2016
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 IMMULITE 2000 Third Generation TSH and Free T4
| Third Generation TSH | Free T4 | |
|---|---|---|
| Trade Name | IMMULITE® 2000 | |
| Third Generation TSH | IMMULITE® 2000 | |
| Free T4 | ||
| Model Numbers | L2KTS2 (200 tests) | |
| L2KTS6 (600 tests) | L2KFT42 (200 tests) | |
| L2KFT46 (600 tests) | ||
| Common Name | Radioimmunoassay, thyroid- | |
| stimulating hormone | Radioimmunoassay, | |
| free thyroxine | ||
| Classification Name | Thyroid stimulating hormone test | |
| system | Free thyroxine test system | |
| Product Code | JLW | CEC |
| Regulation Number | 862.1690 | 862.1695 |
| FDA Classification | Class II | Class II |
| Review Panel | Clinical Chemistry | Clinical Chemistry |
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Predicate Device Information 4.
The Predicate Device for the modified IMMULITE 2000 Free T4 assay is the unmodified IMMULITE 2000 Free T4 assay (K083373).
The Predicate Device for the modified IMMULITE 2000 Third Generation TSH assay is the unmodified IMMULITE 2000 Third Generation TSH assay (described in K970227).
The modifications to the IMMULITE 2000 Free T4 and Third Generation TSH assays to add pediatric reference intervals to the Package Inserts are limited to changes in labeling. The update of reference intervals does not require modifications to the design or manufacturing processes of the devices. Therefore, the predicate devices and subject devices are the same.
5. Substantial Equivalence Information
The following table demonstrates substantial equivalence between the predicate IMMULITE 2000 Free T4 (K083373) and the IMMULITE 2000 Free T4 which has modified Instructions for Use (Package Inserts) with added pediatric reference intervals.
| Item | Predicate Device (K083373)
with Unmodified Labeling | Subject Device
with Updated Reference Intervals |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analytes | free thyroxine (T4) | Same |
| Instruments | IMMULITE 2000 systems | Same |
| Intended Use
Statements | For in vitro diagnostic use with the
IMMULITE® 2000 Systems
Analyzers — for the quantitative
measurement of non-protein-bound
thyroxine (free T4) in serum and
heparinized plasma, as an aid in the
clinical assessment of thyroid
status. | For in vitro diagnostic use with the
IMMULITE® 2000 Systems
Analyzers — for the quantitative
measurement of non-protein-bound
thyroxine (free T4) in serum and
heparinized plasma. Measurements
of free thyroxine are used in the
diagnosis and treatment of thyroid
disease. |
| Analytical
Measuring Range
(Assay Range) | 0.30 - 6.00 ng/dL
(3.9 - 77.2 pmol/L) | Same |
| Adult
Reference Ranges | Euthyroid
Hypothyroid
Hyperthyroid | Same |
| Pediatric
Reference Intervals | None | Infants: 01 – 23 months
Children: 02 – 12 years
Adolescents: 13 – 20 years |
Table 2. Summary of Substantial Equivalence for IMMULITE 2000 Free T4
The following table demonstrates substantial equivalence between the predicate IMMULITE 2000 Third Generation TSH (described in K970227) and the IMMULITE 2000 Third Generation TSH which has modified Instructions for Use (Package Inserts) with updated pediatric reference intervals.
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| Item | Predicate Device (K970227)
with Unmodified Labeling | Subject Device
with Updated Reference Intervals |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analytes | thyroid stimulating hormone (TSH) | Same |
| Instruments | IMMULITE 2000 systems | Same |
| Intended Use
Statements | For in vitro diagnostic use with the
IMMULITE® 2000 Systems
Analyzers — for the quantitative
measurement of thyrotropin (TSH)
in serum, as an aid in the clinical
assessment of thyroid status. | For in vitro diagnostic use with the
IMMULITE® 2000 Systems
Analyzers — for the quantitative
measurement of thyrotropin (TSH)
in serum. 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) | 0.004 – 75 μIU/mL (mIU/L) | Same |
| Adult
Reference Ranges | Euthyroid
Hyperthyroid | Same |
| Pediatric
Reference Intervals | Groupings by age (in years) from
1 year to 12 years | Infants: 01 – 23 months
Children: 02 – 12 years
Adolescents: 13 – 20 years |
Table 3. Summary of Substantial Equivalence for IMMULITE 2000 Third Generation TSH
Standard/Guidance Document Reference 6.
Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline -- Third Edition (CLSI EP28-A3c); FDA Recognition Number 7-224.
7. Pediatric Reference Intervals
Free T4
Data from a total of 426 patients (81 infants, 197 children, 148 adolescents) tested with the IMMULITE 2000 Free T4 assay were analyzed to establish the reference intervals for the studied pediatric population. Results are described in the following table.
| Group | N | 95% Reference
Interval | Reference
Interval
Methodology | 90% Confidence
Interval for Lower
Limit of Reference
Interval | 90% Confidence
Interval for Upper
Limit of Reference
Interval |
|--------------------------------|-----|-------------------------------------------|--------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|
| Infants
(01 – 23 months) | 81 | 0.80 – 1.27 ng/dL
(10.3 – 16.3 pmol/L) | Robust
Symmetric | 0.76 – 0.84 ng/dL
(9.8 – 10.8 pmol/L) | 1.23 – 1.32 ng/dL
(15.8 – 17.0 pmol/L) |
| Children
(02 – 12 years) | 197 | 0.74 – 1.28 ng/dL
(9.5 – 16.5 pmol/L) | Non-Parametric | --- | --- |
| Adolescents
(13 – 20 years) | 148 | 0.75 – 1.27 ng/dL
(9.7 – 16.3 pmol/L) | Non-Parametric | --- | --- |
Table 4. Pediatric 95% Reference Intervals (Free T4)
As taken from information in the existing Instructions for Use (Package Insert), the claim for the euthyroid adult reference range is 0.89 - 1.76 ng/dL (11.5 - 22.7 pmol/L), and the
6
current claim for the assay range is 0.30 – 6.00 ng/dL (3.9 – 77.2 pmol/L). This demonstrates that the new pediatric reference intervals are within the analytical measuring capability of the assay.
Third Generation TSH
Data from a total of 433 patients (90 infants, 195 children, 148 adolescents) tested with the IMMULITE 2000 Third Generation TSH assay were analyzed to establish the reference intervals for the studied pediatic population. These pediatric reference intervals, as well as the previously-established euthyroid adult reference intervals and analytical measuring ranges, are presented below.
| Group | N | 95% Reference Interval | Reference Interval Methodology | 90% Confidence Interval for Lower Limit of Reference Interval | 90% Confidence Interval for Upper Limit of Reference Interval |
|---|---|---|---|---|---|
| Infants | |||||
| (01 – 23 months) | 90 | 0.83 – 6.5 µIU/mL | |||
| (mIU/L) | Robust | ||||
| Symmetric after | |||||
| Log Transform | 0.70 – 0.99 µIU/mL | ||||
| (mIU/L) | 5.58 – 7.65 µIU/mL | ||||
| (mIU/L) | |||||
| Children | |||||
| (02 – 12 years) | 195 | 0.58 – 4.1 µIU/mL | |||
| (mIU/L) | Non-Parametric | --- | --- | ||
| Adolescents | |||||
| (13 – 20 years) | 148 | 0.39 – 4.0 µIU/mL | |||
| (mIU/L) | Non-Parametric | --- | --- |
Table 5. Pediatric 95% Reference Intervals (Third Generation TSH)
As taken from information in the existing Instructions for Use (Package Insert), the claim for the euthyroid adult reference range is 0.40 - 4.0 µIU/mL (mIU/L), and the current claim for the assay range is 0.004 – 75 µIU/mL (mIU/L). This demonstrates that the new pediatric reference intervals are within the analytical measuring capability of the assay.
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 currently claimed for the IMMULITE Free T4 and Third Generation TSH assays continue to apply to these devices.
Specifically, the following studies are not needed for the purpose of this submission:
- l Precision/Reproducibility
- I Linearity
- l Calibrator/Assay Traceability
- Calibrator/Assay Stability
- l Assay Cut-off
- I Method Comparison
- I Matrix Comparison
- l Sensitivity (Detection Limits, LoB, LoD, LoQ)
- Analytical Specificity
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9. Shelf-Life
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 currently claimed for the IMMULITE Free T4 and Third Generation TSH assays continue to apply to these devices.
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 IMMULITE Free T4 and Third Generation TSH assays with updated pediatric reference intervals are substantially equivalent to the currently marketed IMMULITE Free T4 and Third Generation TSH assays.
The modification of the Instructions for Use (Package Insert) to add/update pediatric reference intervals does not require a change in the device design or a change in the manufacturing process.
All analytical data currently claimed for the IMMULITE Free T4 and Third Generation TSH assays continue to apply to these devices.
The modification of pediatric reference intervals for the IMMULITE Free T4 and Third Generation TSH assays is further supported by the following rationale:
-
- Testing of pediatric patients is within the established indications for use (i.e. for use in the diagnosis of thyroid or pituitary disorders), as described in 21 CFR §862.1695 and 21 CFR §862.1690.
-
- The newly-established pediatric reference intervals are at comparable levels or above the existing reference ranges for euthyroid (normal thyroid) adult populations. In addition, the pediatric reference intervals are well within the analytical measuring ranges of the IMMULITE Free T4 and Third Generation TSH assays. Therefore, the IMMULITE Free T4 and Third Generation TSH assays have appropriate analytical performance to test pediatric patients.