Atellica® IM TSH3-Ultra II (TSH3ULII)
Device Facts
| Record ID | K251543 |
|---|---|
| Device Name | Atellica® IM TSH3-Ultra II (TSH3ULII) |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product Code | JLW · Clinical Chemistry |
| Decision Date | Feb 6, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1690 |
| Device Class | Class 2 |
Intended Use
The Atellica® IM TSH3-Ultra II (TSH3ULII) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
Device Story
In vitro diagnostic assay for quantitative TSH measurement; utilizes immunologic sandwich principle with direct chemiluminescent detection; input: human serum or plasma samples; processing: anti-FITC monoclonal antibody on paramagnetic particles, FITC-labeled anti-TSH capture antibody, and acridinium ester-labeled anti-TSH tracer antibody; output: quantitative TSH concentration; used on Atellica IM Analyzer in clinical laboratory settings; results interpreted by healthcare providers to diagnose thyroid or pituitary dysfunction.
Clinical Evidence
Bench testing only. Precision/reproducibility evaluated per CLSI EP05-A3 (N=80 per sample for precision; N=225 for reproducibility). Linearity assessed per CLSI EP06 (range 0.004–158.0 μIU/mL). Method comparison (N=323 samples) against predicate showed Passing-Bablok slope 0.97, intercept -0.006, r=0.998. LoB 0.001 μIU/mL, LoD 0.003 μIU/mL, LoQ 0.004 μIU/mL.
Technological Characteristics
Immunologic sandwich assay; direct chemiluminescent detection. Solid phase: paramagnetic particles with anti-FITC and FITC-labeled anti-TSH antibody. Tracer: acridinium ester-labeled anti-TSH antibody. Automated system (Atellica IM Analyzer). Traceable to WHO 3rd IRP 81/565. Sample volume: 75 μL.
Indications for Use
Indicated for quantitative determination of TSH in human serum and plasma to aid in the diagnosis of thyroid or pituitary disorders in patients.
Regulatory Classification
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.
Predicate Devices
- ADVIA Centaur® TSH3-Ultra II (TSH3ULII) (K233050)
Related Devices
- K233050 — ADVIA Centaur® TSH3-Ultra II (TSH3ULII) · Siemens Healthcare Diagnostics, Inc. · Apr 4, 2024
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
February 6, 2026
Siemens Healthcare Diagnostics, Inc.
Kelly Scuderi
Regulatory Affairs Professional
511 Benedict Ave
Tarrytown, New York 10591
Re: K251543
Trade/Device Name: Atellica® IM TSH3-Ultra II (TSH3ULII)
Regulation Number: 21 CFR 862.1690
Regulation Name: Thyroid Stimulating Hormone Test System
Regulatory Class: Class II
Product Code: JLW
Dated: Dec 29, 2025
Received: Dec 29, 2025
Dear Kelly Scuderi:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K251543 - Kelly Scuderi
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
{2}
K251543 - Kelly Scuderi
Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
PAULA V. CAPOSINO -S
Paula Caposino, Ph.D.
Deputy Director
Division of Chemistry and
Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
{3}
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K251543 | |
| Device Name Atellica® IM TSH3-Ultra II (TSH3ULII) | |
| Indications for Use (Describe) The Atellica® IM TSH3-Ultra II (TSH3ULII) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM Analyzer. 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) | |
| 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." | |
{4}
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K251543
1. Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Avenue
Tarrytown, NY 10591 USA
Contact: Kelly Scuderi
Title: Regulatory Affairs Professional
E-mail: kelly.scuderi@siemens-healthineers.com
Phone: 781-856-6516
Date of Preparation: December 29, 2025
2. Device
Regulatory Information
| Device Name: | Atellica® IM TSH3-Ultra II (TSH3ULII) |
| --- | --- |
| Classification Name: | Thyroid stimulating hormone test system |
| Regulation Number: | 21 CFR 862.1690 |
| Classification: | Class II |
| Product Code: | JLW |
| Review Panel: | Clinical Chemistry |
3. Predicate Device
The predicate device, ADVIA Centaur® TSH3-Ultra II (TSH3ULII) manufactured by Siemens Healthcare Diagnostics, Inc, Tarrytown, NY USA, was cleared by the FDA under K233050.
4. Device Description
This assay is a third-generation assay that employs anti-FITC monoclonal antibody covalently bound to paramagnetic particles, an FITC-labeled anti-TSH capture mouse monoclonal antibody, and a tracer consisting of a proprietary acridinium ester and an anti-TSH mouse monoclonal antibody conjugated to bovine serum albumin (BSA) for chemiluminescent detection.
5. Intended Use
The Atellica® IM TSH3-Ultra II (TSH3ULII) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma
{5}
(EDTA and lithium heparin) using the Atellica® IM Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
## 6. Indications for Use
Same as Intended use.
## 7. Comparison of Technological Characteristics with the Predicate Device
The following table provides a comparison between the predicate and candidate device.
| Attribute | Candidate Device: Atellica IM TSH3-Ultra II | Predicate Device: ADVIA Centaur TSH3-Ultra II |
| --- | --- | --- |
| Intended Use / Indications for Use | The Atellica® IM TSH3-Ultra II (TSH3ULII) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. | The ADVIA Centaur® TSH3-Ultra II (TSH3ULII) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP system. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. |
| Analyte | TSH | Same |
| Automated | Automated assay | Same |
| Measurement | Quantitative | Same |
| Sample Type | Human serum and plasma | Same |
| Detection Limit | LoQ: ≤ 0.008 μIU/mL (mIU/L) | LoQ: ≤ 0.010 μIU/mL (mIU/L) |
| Assay Range | 0.008 - 150.000 μIU/mL (mIU/L) | 0.010 - 150.000 μIU/mL (mIU/L) |
| Operating Principle | Immunologic sandwich | Same |
| Technology | Direct chemiluminescent | Same |
| Lite Reagent Antibody | Mouse monoclonal anti-TSH antibody BSA conjugate labeled with acridinium ester | Same |
| Solid Phase Antibody | FITC-labeled mouse monoclonal anti-TSH antibody and mouse monoclonal anti-fluorescein antibody linked to paramagnetic particles | Same |
| Ancillary Antibody | FITC conjugated to mouse monoclonal anti-TSH antibody | Same |
| Sample Volume | 75 μL | 100 μL |
| Calibrator | After reconstitution, TSH (human); buffer; equine serum; sodium azide (< 0.1%); stabilizers; preservatives | Same |
| Number of Calibrators | 2 levels (low and high) | Same |
| Calibrators Packaging | Provided with reagent kit | Same |
| Use of Controls | Yes (recommended) | Same |
{6}
| Traceability | Traceable to the World Health Organization (WHO) 3rd International Reference Preparation for human TSH (IRP 81/565). | Same |
| --- | --- | --- |
# 8. Performance Characteristics Data
# Detection Capability
Detection capability was determined using the Atellica IM Analyzer in accordance with CLSI Document EP17-A2. The following results are representative of the performance of the assay.
| Detection Capability | Atellica IM Analyzer Result |
| --- | --- |
| Limit of Blank (LoB) | 0.001 μIU/mL (mIU/L) |
| Limit of Detection (LoD) | 0.003 μIU/mL (mIU/L) |
| Limit of Quantitation (LoQ) | 0.004 μIU/mL (mIU/L) |
The LoB corresponds to the highest measurement result likely to be observed for a blank sample with a probability of $95\%$ .
The LoD corresponds to the lowest analyte concentration that can be detected with a probability of $95\%$ .
The LoQ corresponds to the lowest analyte concentration at which the within laboratory CVs $20.0\%$ .
# Precision
Precision was determined in accordance with CLSI Document EP05-A3. Samples were assayed in replicates of 2 with 2 runs per day using a 20-day protocol.
The following results are representative of the performance of the assay:
{7}
| Sample | Na | Mean μIU/mL (mIU/L) | Repeatability | | Within-Laboratory Precision | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SDb μIU/mL (mIU/L) | CVc (%) | SD μIU/mL (mIU/L) | CV (%) |
| Serum A | 80 | 0.086 | 0.0018 | 2.1 | 0.0027 | 3.2 |
| Serum B | 80 | 0.194 | 0.0043 | 2.2 | 0.0050 | 2.6 |
| Serum C | 80 | 0.496 | 0.0103 | 2.1 | 0.0156 | 3.1 |
| Serum D | 80 | 4.739 | 0.0974 | 2.1 | 0.1328 | 2.8 |
| Serum E | 80 | 48.040 | 1.2643 | 2.6 | 1.7163 | 3.6 |
| Serum F | 80 | 98.207 | 2.4514 | 2.5 | 2.8295 | 2.9 |
| Plasma, lithium heparin A | 80 | 0.096 | 0.0018 | 1.8 | 0.0030 | 3.1 |
| Plasma, lithium heparin B | 80 | 0.513 | 0.0112 | 2.2 | 0.0168 | 3.3 |
| Plasma, lithium heparin C | 80 | 4.802 | 0.1108 | 2.3 | 0.1700 | 3.5 |
| Plasma, lithium heparin D | 80 | 52.769 | 1.1208 | 2.1 | 1.4833 | 2.8 |
| Plasma, lithium heparin E | 80 | 93.097 | 3.1793 | 3.4 | 4.2404 | 4.6 |
| Control 1 | 80 | 0.103 | 0.0016 | 1.6 | 0.0022 | 2.2 |
| Control 2 | 80 | 0.522 | 0.0071 | 1.4 | 0.0121 | 2.3 |
| Control 3 | 80 | 4.800 | 0.0505 | 1.1 | 0.1173 | 2.4 |
| Control 4 | 80 | 47.803 | 0.7748 | 1.6 | 1.0919 | 2.3 |
| Control 5 | 80 | 101.770 | 2.1680 | 2.1 | 2.9022 | 2.9 |
a Number of measurements.
b Standard deviation.
Coefficient of variation.
## Reproducibility
Reproducibility was determined in accordance with CLSI Document EP05-A3. Testing was performed using 3 instruments and 3 reagent lots. Samples were assayed in replicates of 5 with 1 run per day using a 5-day protocol (225 measurements per sample).
The following results are representative of the performance of the assay:
{8}
| Sample | Mean μIU/mL (mIU/L) | Repeatability | | Between Day | | Between Lot | | Between Instrument | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | SD^{a} μIU/mL (mIU/L) | CV^{b} (%) | SD μIU/mL (mIU/L) | CV (%) | SD μIU/mL (mIU/L) | CV (%) | SD μIU/mL (mIU/L) | CV (%) | SD μIU/mL (mIU/L) | CV (%) |
| Serum A | 0.087 | 0.002 | 2.12 | 0.001 | 1.30 | 0.003 | 3.44 | 0.001 | 1.26 | 0.004 | 4.43 |
| Serum B | 0.172 | 0.004 | 2.12 | 0.002 | 1.42 | 0.005 | 2.82 | 0.002 | 0.92 | 0.007 | 3.91 |
| Serum C | 0.449 | 0.009 | 2.04 | 0.004 | 0.92 | 0.011 | 2.52 | 0.003 | 0.58 | 0.015 | 3.42 |
| Serum D | 4.450 | 0.094 | 2.12 | 0.054 | 1.21 | 0.067 | 1.50 | 0.044 | 0.98 | 0.135 | 3.03 |
| Serum E | 53.797 | 1.160 | 2.16 | 0.672 | 1.25 | 1.042 | 1.94 | 0.614 | 1.14 | 1.805 | 3.36 |
| Serum F | 100.021 | 2.250 | 2.25 | 1.789 | 1.79 | 3.066 | 3.06 | 0.590 | 0.59 | 4.244 | 4.24 |
| Plasma A | 0.090 | 0.002 | 2.23 | 0.001 | 1.07 | 0.003 | 3.54 | 0.002 | 1.86 | 0.004 | 4.70 |
| Plasma B | 0.422 | 0.009 | 2.13 | 0.004 | 1.06 | 0.010 | 2.42 | 0.007 | 1.54 | 0.016 | 3.73 |
| Plasma C | 4.293 | 0.080 | 1.86 | 0.082 | 1.91 | 0.065 | 1.52 | 0.023 | 0.54 | 0.134 | 3.12 |
| Plasma D | 47.836 | 1.052 | 2.20 | 0.789 | 1.65 | 0.768 | 1.61 | 0.731 | 1.53 | 1.689 | 3.53 |
| Plasma E | 98.087 | 2.139 | 2.18 | 2.512 | 2.56 | 2.877 | 2.93 | 1.824 | 1.86 | 4.743 | 4.84 |
| Control 1 | 0.102 | 0.002 | 2.06 | 0.001 | 1.12 | 0.004 | 3.71 | 0.001 | 0.69 | 0.005 | 4.44 |
| Control 2 | 0.506 | 0.008 | 1.63 | 0.005 | 1.08 | 0.013 | 2.57 | 0.003 | 0.59 | 0.017 | 3.28 |
| Control 3 | 4.627 | 0.082 | 1.78 | 0.045 | 0.96 | 0.079 | 1.70 | 0.024 | 0.52 | 0.125 | 2.69 |
| Control 4 | 45.957 | 0.854 | 1.86 | 0.586 | 1.28 | 0.725 | 1.58 | 0.000 | 0.00 | 1.264 | 2.75 |
| Control 5 | 97.579 | 2.007 | 2.06 | 1.228 | 1.26 | 2.508 | 2.57 | 0.000 | 0.00 | 3.439 | 3.52 |
a Standard deviation.
b Coefficient of variation.
## Assay Comparison
Assay comparison was determined with the Passing-Bablok regression model in accordance with CLSI Document EP09c-ed3.
Agreement of the assays may vary depending on the study design, comparative assay, and population tested.
| Sample | Comparative Assay (x) | Regression Equation | Sample Interval | Na | rb |
| --- | --- | --- | --- | --- | --- |
| Serum | Atellica IM TSH3-UL assay using the Atellica IM Analyzer | y = 0.97x - 0.006 μIU/mL | 0.011–147.2 μIU/mL | 323 | 0.998 |
a Number of samples tested.
b Correlation coefficient.
{9}
# Specimen Equivalency
Specimen equivalency was determined with the Passing-Bablok regression model using the ADVIA Centaur XP system in accordance with CLSI Document EP09c-ed3.
Agreement of the specimen types may vary depending on the study design and population tested.
| Tube (y) vs. Serum (x) | Regression Equation | Sample Interval | N^{a} | r^{b} |
| --- | --- | --- | --- | --- |
| Plasma, EDTA | y = 0.99x - 0.017 μIU/mL | 0.008–147.8 μIU/mL | 53 | 0.999 |
| Plasma, lithium heparin | y = 1.01x - 0.034 μIU/mL | 0.115–135.9 μIU/mL | 57 | 0.990 |
a Number of samples tested.
b Correlation coefficient.
# Interferences
Hemolysis, Icterus, Lipemia (HIL):
Interference testing was performed using the ADVIA Centaur XP system in accordance with CLSI Document EP07-ed3.
The following substances do not interfere with the assay when present in serum at the concentrations indicated. Bias due to these substances does not exceed 10% at a TSH concentration of approximately 0.900 μIU/mL (mIU/L) and 8.000 μIU/mL (mIU/L).
| Substance | Substance Test Concentration |
| --- | --- |
| Hemoglobin | 500 mg/dL (5.00 g/L) |
| Bilirubin, conjugated | 40 mg/dL (474 μmol/L) |
| Bilirubin, unconjugated | 40 mg/dL (684 μmol/L) |
| Lipemia (Intralipid) | 1000 mg/dL (11.3 mmol/L) |
# Other Substances:
Interference testing was performed using the ADVIA Centaur XP system in accordance with CLSI Document EP07-ed3.
The following substances do not interfere with the assay when present in serum at the concentrations indicated. Bias due to these substances does not exceed 10% at TSH concentrations of approximately 0.900 μIU/mL (mIU/L) and 8.000 μIU/mL (mIU/L).
{10}
| Substance | Substance Test Concentration | Substance | Substance Test Concentration |
| --- | --- | --- | --- |
| Acetaminophen | 15.6 mg/dL (1033 μmol/L) | Liothyronine | 0.0075 mg/dL (0.116 μmol/L) |
| Acetylsalicylic acid | 3.0 mg/dL (167 μmol/L) | Methimazole | 8.0 mg/dL (701 μmol/L) |
| Ampicillin | 7.5 mg/dL (215 μmol/L) | Methyldopa | 2.25 mg/dL (107 μmol/L) |
| Ascorbic Acid | 5.25 mg/dL (298 μmol/L) | Metronidazole | 12.3 mg/dL (719 μmol/L) |
| Biotin | 0.35 mg/dL (14.3 μmol/L) | N-Acetylcysteine | 15.0 mg/dL (920 μmol/L) |
| Carbimazole | 3.0 mg/dL (161 μmol/L) | Octreotide | 0.03 mg/dL (0.294 μmol/L) |
| Cefoxitin | 495 mg/dL (11583 μmol/L) | Phenylbutazone | 32.1 mg/dL (1040 μmol/L) |
| Cholesterol | 400 mg/dL (10.3 mmol/L) | Propranolol | 24 mg/dL (926 μmol/L) |
| Cyclosporine | 0.18 mg/dL (1.50 μmol/L) | Propylthiouracil | 30 mg/dL (1762 μmol/L) |
| Doxycycline | 1.8 mg/dL (40.5 μmol/L) | Rheumatoid Factor | 1500 IU/mL |
| Heparin | 7500 U/dL | Rifampicin | 4.8 mg/dL (58.6 μmol/L) |
| Ibuprofen | 21.9 mg/dL (1062 μmol/L) | Theophylline | 6.0 mg/dL (333 μmol/L) |
| Levodopa | 0.75 mg/dL (38.0 μmol/L) | Total Protein | 15 g/dL (150 g/L) |
| Levothyroxine | 0.0429 mg/dL (0.552 μmol/L) | | |
## Cross-Reactivity
Cross-reactivity was determined using the ADVIA Centaur XP system in accordance with CLSI Document EP07-ed3. Cross-reactivity of samples spiked with various substances does not exceed 5% at TSH concentrations of approximately 0.400 μIU/mL (mIU/L), 5.00 μIU/mL (mIU/L), 17.00 μIU/mL (mIU/L), and 90.00 μIU/mL (mIU/L).
| Substance | Substance Test Concentration |
| --- | --- |
| hCG | 200,000 mIU/mL |
| FSH | 1500 mIU/mL |
| LH | 600 mIU/mL |
## Linearity
Linearity testing was performed in accordance with CLSI Document EP06-ed2 using the Atellica IM Analyzer.
The assay is linear for the measuring interval of 0.008–150.000 μIU/mL (mIU/L).
{11}
High-Dose Hook Effect
High TSH concentrations can cause a paradoxical decrease in the RLUs (high-dose hook effect). In this assay, patient samples with TSH concentrations above the measuring interval and as high as 3000 µIU/mL will report > 150 µIU/mL (mIU/L).
Standardization
The assay standardization is traceable to the World Health Organization (WHO) 3rd International Reference Preparation for human TSH (IRP 81/565).
Assigned values for calibrators are traceable to this standardization.
9. Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
