(267 days)
Not Found
No
The device description and performance studies do not mention any AI, DNN, or ML components or algorithms. The device is a diagnostic assay that measures thyroglobulin levels using chemical reagents.
No.
The device is an in vitro diagnostic (IVD) assay used for quantitative measurement of thyroglobulin, which aids in monitoring thyroid cancer, not for treating or preventing disease.
Yes
The "Intended Use" section explicitly states that the Atellica IM Thyroglobulin (Tg) assay is an "in vitro diagnostic use" for the quantitative measurement of thyroglobulin, which is used as an "aid in monitoring differentiated thyroid cancer patients." This clearly indicates its diagnostic purpose.
No
The device is a laboratory assay (an in vitro diagnostic test) that measures a biomarker (thyroglobulin) in a patient's serum or plasma using specific chemical reagents and an analyzer. This involves physical components (reagents, microparticles), not just software.
Yes.
The device is explicitly stated as being for "in vitro diagnostic use" and measures a biomarker (thyroglobulin) in human bodily fluids (serum and plasma) to aid in monitoring a medical condition (differentiated thyroid cancer).
N/A
Intended Use / Indications for Use
The Atellica IM Thyroglobulin (Tg) assay is for in vitro diagnostic use in the quantitative measurement of thyroglobulin in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM Analyzer.
Thyroglobulin measurements are used as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.
Product codes (comma separated list FDA assigned to the subject device)
MSW
Device Description
The Atellica® IM Thyroglobulin (Tg) includes the Tg ReadyPack® primary reagent pack (Lite Reagent and Solid Phase) and Ancillary Well Reagent. The Lite Reagent contains Mouse monoclonal anti-human Tg antibody labeled with acridinium ester, bovine serum albumin (BSA), mouse IgG, buffer, stabilizers, and preservatives. The Solid Phase contains Streptavidin-coated paramagnetic microparticles preformed with biotinylated mouse monoclonal antihuman Tg antibody, BSA, mouse IgG, buffer, stabilizers, and preservatives. The Ancillary Well Reagent contains BSA, bovine gamma globulin, buffer, and preservatives. The Atellica IM Tg MCM (MCM 1 and MCM 2–5) are sold separately. MCM 1 contains bovine serum albumin (BSA), buffer, stabilizers, and preservatives after reconstitution. MCM 2–5 contain various levels of human thyroglobulin, BSA, buffer, stabilizers, and preservatives after reconstitution.
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
Apparently healthy adults (≥ 22 years)
Post-thyroidectomy adults (≥ 22 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
A prospective, multi-center study was conducted using the Atellica IM Analyzer to assess the clinical performance of the Atellica IM Tg assay. A total of 291 serum samples were collected from 189 subjects diagnosed with differentiated thyroid cancer, 6 or more weeks following thyroidectomy or radioiodine ablation.
Sensitivity and specificity were calculated by comparing the Atellica IM Tg assay result to structural disease (SD). The assay result was considered positive if the Tg concentration was ≥ 0.2 ng/mL and negative if the Tg concentration was
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
FDA 510(k) Clearance Letter - Atellica IM Thyroglobulin (Tg)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 20, 2025
Siemens Healthcare Diagnostics, Inc.
Mey Vasquez
Regulatory Affairs Professional
511 Benedict Avenue
Tarrytown, New York 10591
Re: K242981
Trade/Device Name: Atellica IM Thyroglobulin (Tg)
Regulation Number: 21 CFR 866.6010
Regulation Name: Tumor-Associated Antigen Immunological Test System
Regulatory Class: Class II
Product Code: MSW
Dated: May 21, 2025
Received: May 22, 2025
Dear Mey Vasquez:
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.
Page 2
K242981 - Mey Vasquez 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-
Page 3
K242981 - Mey Vasquez 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,
Ying Mao -S
Ying Mao, Ph.D.
Branch Chief
Division of Immunology and Hematology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
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): K242981
Device Name: Atellica IM Thyroglobulin (Tg)
Indications for Use (Describe):
The Atellica IM Thyroglobulin (Tg) assay is for in vitro diagnostic use in the quantitative measurement of thyroglobulin in human serum and plasma (EDTA and lithium heparin) using the Atellica IM Analyzer.
Thyroglobulin measurements are used as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.
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."
Page 5
Siemens Healthcare Diagnostics 510(k) Summary
Siemens Healthcare Diagnostics, Inc
510(k) Submission – Atellica IM Tg Assay (K242981)
Page 1 of 12
510(k) Summary of Safety and Effectiveness
Introduction: According to the requirements of SMDA 1990 and 21 CFR 807.92, the following information provides sufficient details to understand the basis for determination of substantial equivalence.
The assigned 510(k) Number: K242981
1. Date Prepared
June 12, 2025
2. Applicant Information
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue,
Tarrytown, NY 10591 USA
Contact: Mey Vasquez
Regulatory Affairs Professional
E-mail: mey.vasquez@siemens-healthineers.com
3. Regulatory Information
| Assay | |
|---|---|
| Trade Name | Atellica IM Thyroglobulin (Tg) |
| Device | Thyroglobulin Test System |
| Definition | Thyroglobulin test system is an in vitro diagnostic device intended to measure Thyroglobulin in human serum and plasma. The test is intended to be used as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation. |
| FDA Classification | Class II |
| Review Panel | Clinical Chemistry |
| Product Code | MSW |
Page 6
Siemens Healthcare Diagnostics
510(k) Summary
Siemens Healthcare Diagnostics, Inc
510(k) Submission – Atellica IM Tg Assay (K242981)
Page 2 of 12
| Regulation Number | 21 CFR 866.6010 |
|---|
4. PREDICATE DEVICE
Name of Device: Access Thyroglobulin
510(k): K241423
5. DEVICE DESCRIPTION
The following devices are included in the Atellica® IM Thyroglobulin (Tg):
| Material | Description |
|---|---|
| Tg ReadyPack® primary reagent pack | |
| Lite Reagent | 7.5 mL/reagent pack |
| Mouse monoclonal anti-human Tg antibody labeled with acridinium ester (~1.13 μg/mL); bovine serum albumin (BSA); mouse IgG; buffer; stabilizers; preservatives | |
| Solid Phase | 15.0 mL/reagent pack |
| Streptavidin-coated paramagnetic microparticles preformed with biotinylated mouse monoclonal antihuman Tg antibody (~267 μg/mL); BSA; mouse IgG; buffer; stabilizers; preservatives | |
| Ancillary Well Reagent | 6.0 mL/reagent pack |
| BSA; bovine gamma globulin; buffer; preservatives | |
| Tg CAL | 2.0 mL/vial |
| After reconstitution, human thyroglobulin; BSA; buffer; stabilizers; preservatives |
The following devices are sold separately:
| Material | Description |
|---|---|
| Atellica IM Tg MCM: |
Page 7
Siemens Healthcare Diagnostics
510(k) Summary
Siemens Healthcare Diagnostics, Inc
510(k) Submission – Atellica IM Tg Assay (K242981)
Page 3 of 12
| MCM 1: | 1.0 mL/vial |
|---|---|
| After reconstitution, bovine serum albumin (BSA); buffer; stabilizers; preservatives | |
| Atellica IM Tg MCM: | |
| MCM 2–5: | 1.0 mL/vial |
| After reconstitution, various levels of human thyroglobulin; BSA; buffer; stabilizers; preservatives |
6. INTENDED USE/ INDICATIONS FOR USE
The Atellica® IM Thyroglobulin (Tg) assay is for in vitro diagnostic use in the quantitative measurement of thyroglobulin in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM Analyzer.
Thyroglobulin measurements are used as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.
7. Special Conditions for Use Statement
For Prescription Use
8. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Candidate Device | Predicate | |
|---|---|---|
| Item | Atellica IM Tg assay | Beckman Coulter Access Thyroglobulin (K241423) |
| Intended Use | The Atellica® IM Thyroglobulin (Tg) assay is for in vitro diagnostic use in the quantitative measurement of thyroglobulin in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM Analyzer. |
Thyroglobulin measurements are used as an aid in monitoring | Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems. This device is |
Page 8
Siemens Healthcare Diagnostics
510(k) Summary
Siemens Healthcare Diagnostics, Inc
510(k) Submission – Atellica IM Tg Assay (K242981)
Page 4 of 12
| Candidate Device | Predicate | |
|---|---|---|
| Item | Atellica IM Tg assay | Beckman Coulter Access Thyroglobulin (K241423) |
| differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation. | intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies. | |
| Indications for Use | Same as Intended Use (Candidate) | Same (for Predicate) |
Similarities
| LoB | 0.039 ng/mL (0.059 pmol/L) | ≤ 0.03 ng/mL |
|---|---|---|
| LoD | 0.044 ng/mL (0.067 pmol/L) | ≤ 0.05 ng/mL |
| LoQ | 0.050 ng/mL (0.076 pmol/L) | ≤ 0.1 ng/mL |
| Measurement | Quantitative | Same |
| Technology | Chemiluminescent | Same |
| Operating Principle | Fully automated Sandwich immunoassay | Same |
| Sample type | Serum, EDTA plasma, lithium heparin plasma | Human Serum and Plasma |
| Standardization | The assay standardization is traceable to the Community Bureau of Reference (BCR) Certified Reference Material (CRM) 457. | Community Bureau of Reference (BCR) Certified Reference Material (CRM) 457 |
Page 9
Siemens Healthcare Diagnostics
510(k) Summary
Siemens Healthcare Diagnostics, Inc
510(k) Submission – Atellica IM Tg Assay (K242981)
Page 5 of 12
| Candidate Device | Predicate | |
|---|---|---|
| Item | Atellica IM Tg assay | Beckman Coulter Access Thyroglobulin (K241423) |
| differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation. | intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies. | |
| Indications for Use | Same as Intended Use (Candidate) | Same (for Predicate) |
Similarities
| LoB | 0.039 ng/mL (0.059 pmol/L) | ≤ 0.03 ng/mL |
|---|---|---|
| LoD | 0.044 ng/mL (0.067 pmol/L) | ≤ 0.05 ng/mL |
| LoQ | 0.050 ng/mL (0.076 pmol/L) | ≤ 0.1 ng/mL |
| Measurement | Quantitative | Same |
| Technology | Chemiluminescent | Same |
| Operating Principle | Fully automated Sandwich immunoassay | Same |
| Sample type | Serum, EDTA plasma, lithium heparin plasma | Human Serum and Plasma |
| Standardization | The assay standardization is traceable to the Community Bureau of Reference (BCR) Certified Reference Material (CRM) 457. | Community Bureau of Reference (BCR) Certified Reference Material (CRM) 457 |
Page 10
Siemens Healthcare Diagnostics
510(k) Summary
Siemens Healthcare Diagnostics, Inc
510(k) Submission – Atellica IM Tg Assay (K242981)
Page 6 of 12
| Candidate Device | Predicate | |
|---|---|---|
| Item | Atellica IM Tg assay | Beckman Coulter Access Thyroglobulin (K241423) |
| Assigned values for calibrators are traceable to this standardization. | ||
| Clinical Cut-Off | 0.2 ng/mL | Not applicable |
| Intended Use Population(s) | Thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation. | Patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies. |
Differences
| Calibration | 2 levels | 6 levels |
|---|---|---|
| Assay Range | 0.050–150 ng/mL (0.076–227 pmol/L) | 0.1 - 500 ng/mL |
| Hook Effect | No hook effect up to 80,000 ng/mL (121,200 pmol/L). | No hook effect up to at least 40,000 ng/mL. |
| Sample Volume | 100 µL | 40 µL |
| Detection Antibody | Mouse monoclonal anti-human Tg antibody labeled with acridinium ester. | Mouse monoclonal anti-thyroglobulin-alkaline phosphatase (bovine) conjugate in a TRIS buffer with protein (bovine, murine). |
| Capture Antibody | Biotinylated mouse monoclonal anti-human Tg antibody that is bound to streptavidin-coated paramagnetic latex particles. | Mouse monoclonal anti-thyroglobulin antibodies coupled to biotin in a HEPES buffer with protein (bovine and mouse). |
Page 11
Siemens Healthcare Diagnostics
510(k) Summary
Siemens Healthcare Diagnostics, Inc
510(k) Submission – Atellica IM Tg Assay (K242981)
Page 7 of 12
9. PERFORMANCE CHARACTERISTICS DATA
9.1. Detection Capability
The limit of blank (LoB), limit of detection (LoD), and the limit of quantitation (LoQ) were determined as described in CLSI protocol EP17-A2.
The Atellica IM Tg assay has a LoB of 0.039 ng/mL (0.059 pmol/L), a LoD of 0.044 ng/mL (0.067 pmol/L), and a LoQ of 0.050 ng/mL (0.076 pmol/L).
9.2. 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:
| Sample | N^a | Mean ng/mL (pmol/L) | Repeatability | Within-Laboratory Precision | ||
|---|---|---|---|---|---|---|
| SD^b ng/mL (pmol/L) | CV^c (%) | SD ng/mL (pmol/L) | CV (%) | |||
| Serum A | 80 | 0.078 (0.118) | 0.005 (0.008) | 6.4 | 0.007 (0.011) | 9.0 |
| Serum B | 80 | 0.153 (0.232) | 0.003 (0.005) | 2.0 | 0.005 (0.008) | 3.3 |
| Serum C | 80 | 1.79 (2.71) | 0.032 (0.048) | 1.8 | 0.042 (0.064) | 2.3 |
| Serum D | 80 | 6.12 (9.27) | 0.082 (0.124) | 1.3 | 0.145 (0.220) | 2.4 |
| Serum E | 80 | 25.1 (38.0) | 0.575 (0.871) | 2.3 | 0.793 (1.20) | 3.2 |
| Serum F | 80 | 78.9 (120) | 0.976 (1.48) | 1.2 | 2.12 (3.21) | 2.7 |
| Serum G | 80 | 136 (206) | 2.59 (3.92) | 1.9 | 3.95 (5.98) | 2.9 |
| Control 1 | 80 | 3.83 (5.80) | 0.097 (0.147) | 2.5 | 0.151 (0.229) | 3.9 |
| Control 2 | 80 | 42.7 (64.7) | 1.24 (1.88) | 2.9 | 1.71 (2.59) | 4.0 |
| Control 3 | 80 | 121 (183) | 2.91 (4.41) | 2.4 | 4.38 (6.64) | 3.6 |
^a Number of measurements.
^b Standard deviation.
^c Coefficient of variation.
Page 12
Siemens Healthcare Diagnostics
510(k) Summary
Siemens Healthcare Diagnostics, Inc
510(k) Submission – Atellica IM Tg Assay (K242981)
Page 8 of 12
9.3. Reproducibility
Reproducibility was determined using the Atellica IM Analyzer in accordance with CLSI document EP05‑A3. Testing was performed using 3 sites and 1 reagent lot. Samples were assayed in replicates of 3 with 2 runs per day using a 5‑day protocol (Number of measurements per sample = 90). The following results are representative of the performance of the assay:
| Sample | Mean ng/mL (pmol/L) | Repeatability | Between-Run | Between-Day | Between-Site | Reproducibility | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| SD^a ng/mL (pmol/L) | CV^b (%) | SD ng/mL (pmol/L) | CV (%) | SD ng/mL (pmol/L) | CV (%) | SD ng/mL (pmol/L) | CV (%) | SD ng/mL (pmol/L) | CV (%) | ||
| Serum A | 0.155 (0.235) | 0.005 (0.008) | 3.2 | 0.000 (0.000) | 0.0 | 0.000 (0.000) | 0.0 | 0.003 (0.005) | 1.9 | 0.006 (0.009) | 3.9 |
| Serum B | 1.83 (2.77) | 0.031 (0.047) | 1.7 | 0.015 (0.023) | 0.8 | 0.008 (0.012) | 0.4 | 0.101 (0.153) | 5.5 | 0.107 (0.162) | 5.8 |
| Serum C | 25.7 (38.9) | 0.321 (0.486) | 1.2 | 0.100 (0.152) | 0.4 | 0.098 (0.148) | 0.4 | 0.359 (0.544) | 1.4 | 0.501 (0.759) | 1.9 |
| Serum D | 74.5 (113) | 1.12 (1.70) | 1.5 | 0.000 (0.000) | 0.0 | 0.243 (0.368) | 0.3 | 1.91 (2.89) | 2.6 | 2.23 (3.38) | 3.0 |
| Serum E | 119 (180) | 1.76 (2.67) | 1.5 | 0.716 (1.08) | 0.6 | 0.845 (1.28) | 0.7 | 4.53 (6.86) | 3.8 | 4.99 (7.56) | 4.2 |
| Control 1 | 4.35 (6.59) | 0.070 (0.106) | 1.6 | 0.049 (0.074) | 1.1 | 0.053 (0.080) | 1.2 | 0.065 (0.098) | 1.5 | 0.120 (0.182) | 2.8 |
| Control 2 | 43.6 (66.1) | 0.812 (1.23) | 1.9 | 0.499 (0.756) | 1.1 | 0.000 (0.000) | 0.0 | 1.29 (1.95) | 3.0 | 1.60 (2.42) | 3.7 |
| Control 3 | 128 (194) | 2.53 (3.83) | 2.0 | 1.69 (2.56) | 1.3 | 0.000 (0.000) | 0.0 | 6.38 (9.67) | 5.0 | 7.07 (10.7) | 5.5 |
9.4. Linearity
Linearity testing was performed using the Atellica IM Analyzer in accordance with CLSI Document EP06‑ed2. The assay is linear for the measuring interval of 0.050–150 ng/mL (0.076–227 pmol/L).
9.5. Specimen Equivalence
Specimen equivalency was tested in accordance with the governing standard CLSI Document EP09c‑ed3. Specimen matrix studies were conducted to compare serum to the following specimen types and collection devices: dipotassium EDTA plasma, lithium heparin
Page 13
Siemens Healthcare Diagnostics
510(k) Summary
Siemens Healthcare Diagnostics, Inc
510(k) Submission – Atellica IM Tg Assay (K242981)
Page 9 of 12
plasma, serum gel barrier tube, lithium heparin plasma gel-barrier tube. Each matrix comparison study included a minimum of 84 paired samples across the assay measuring interval. Results of these studies confirm that the performance of the assay is equivalent across the supported specimen types and collection devices.
9.6. Interferences
Hemolysis, Icterus, Lipemia (HIL)
Interference testing was performed using the Atellica IM Analyzer in accordance with CLSI document EP07‑ed3. Interference as defined by bias greater than 10% was not observed for the following substances when tested at analyte concentrations of 0.144–0.224 ng/mL (0.218–0.339 pmol/L) and 21.9–26.9 ng/mL (33.2–40.8 pmol/L).
| Substance | Substance Test Concentration |
|---|---|
| Hemoglobin | 1000 mg/dL |
| Bilirubin, conjugated | 60 mg/dL |
| Bilirubin, unconjugated | 60 mg/dL |
| Lipemia (Intralipid) | 1900 mg/dL |
| Lipemia (triglycerides) | 1500 mg/dL |
Other Substances
Interference testing was performed using the Atellica IM Analyzer in accordance with CLSI document EP07‑ed3.19 Interference as defined by bias greater than 10% was not observed for the following substances when tested at analyte concentrations of 0.125–0.235 ng/mL (0.189–0.356 pmol/L) and 21.6–27.8 ng/mL (32.7–42.1 pmol/L).
| Substance | Substance Test Concentration | Substance | Substance Test Concentration |
|---|---|---|---|
| Acetaminophen | 20 mg/dL | Itraconazole | 3 mg/dL |
| Acetylsalicylic Acid (Aspirin) | 65 mg/dL | K3 EDTA | 5.4 mg/mL |
| AFP | 881.24 ng/mL | Lenvatinib Mesylate | 2.62 mg/dL |
| Amiodarone | 8.92 µmol/L | Levodopa | 0.75 mg/dL |
| Ampicillin | 33.0 mg/dL | Methyldopa | 2.25 mg/dL |
| Ascorbic Acid | 2590 mg/dL | Metronidazole | 12.3 mg/dL |
| Biotin | 3510 ng/mL | Octreotide Acetate (Sandostatin) | 5.2 ng/mL |
Page 14
Siemens Healthcare Diagnostics
510(k) Summary
Siemens Healthcare Diagnostics, Inc
510(k) Submission – Atellica IM Tg Assay (K242981)
Page 10 of 12
| Substance | Substance Test Concentration | Substance | Substance Test Concentration |
|---|---|---|---|
| Cabozantinib-S-Malate | 15.3 mg/dL | Perchlorate | 200 µg/mL |
| Carbimazole | 2.4 µg/mL | Phenylbutazone | 32.1 mg/dL |
| Cefoxitin | 92.7 mg/dL | Prednisolone | 8.31 µmol/L |
| Cyclosporine | 0.075 mg/dL | Propranolol | 7.71 µmol/L |
| Doxycycline | 4.5 mg/dL | Propylthiouracil | 7.2 µg/mL |
| Fluocortolone | 270 ng/mL | Rifampicin | 7.5 mg/dL |
| Fluorescein | 6 µg/mL | Rheumatoid Factor (RF) | 550 IU/mL |
| FSH | 40 mIU/mL | Silwet L720 | 0.03 mg/mL |
| Hydrocortisone | 984 ng/mL | TBG (thyroxine binding globulin) | 210 µg/mL |
| Ibuprofen | 50 mg/dL | Theophylline | 6 mg/dL |
| Imatinib (TKI) | 13.4 µg/mL | Thiamazole (Methimazole) | 300 ng/mL |
| Immunoglobulin G (IgG) | 2 g/dL | Total Protein | 30 mg/mL |
| Immunoglobulin M (IgM) | 0.3 g/dL | Total Protein | 120 mg/mL |
| Iodide | 38 mg/dL | VEGF | 2835 pg/mL |
9.7. Cross-Reactivity
Cross-reactivity was determined using the Atellica IM Analyzer in accordance with CLSI document EP07‑ed3. Cross-reactivity of samples spiked with various substances does not exceed 1.0% at analyte concentrations of 0.185–0.261 ng/mL (0.280–0.395 pmol/L) and 23.9–27.5 ng/mL (36.2–41.6 pmol/L).
| Substance | Substance Test Concentration |
|---|---|
| T3 | 100 ng/mL |
| T4 | 10 µg/mL |
| TSH | 235 mIU/mL |
| Galectin-3 | 1 µg/mL |
| Diiodothyronine (T2) | 55 µg/mL |
Page 15
Siemens Healthcare Diagnostics
510(k) Summary
Siemens Healthcare Diagnostics, Inc
510(k) Submission – Atellica IM Tg Assay (K242981)
Page 11 of 12
9.8. Reagent Stability
The on-board stability of the Atellica IM Tg reagents was determined to be 28 days on AIM with a calibration interval of 50 days.
The Atellica IM Tg calibrators when reconstituted were determined to be stable at 2-8°C and ≤ -20°C for 45 days and 60 days (thaw only once), respectively.
9.9. Sample Stability
- After centrifugation, specimens in the primary collection device are stable for up to 3 days at 2–8°C. Samples in the primary collection device include serum stored on the clot, plasma stored on packed red cells, and samples processed and stored in gel-barrier blood collection tubes.
- Separated serum samples are stable for up to 4 days at room temperature, and for up to 7 days at 2–8°C.
- Separated plasma samples are stable for up to 3 days at room temperature, and for up to 4 days at 2–8°C.
- Separated samples are stable at ≤ -20°C for up to 12 months and at ≤ -70°C for up to 24 months. Avoid more than 4 freeze-thaw cycles. Do not store in a frost-free freezer. Thoroughly mix thawed samples and centrifuge them before using.
9.10. High Dose Hook Effect
High Tg concentrations can cause a paradoxical decrease in the RLUs (high-dose hook effect). In this assay, no hook effect was observed up to 80,000 ng/mL (121,200 pmol/L).
9.11. Expected Values
Reference intervals were established on the Atellica IM Analyzer in accordance with CLSI Document EP28‑A3c. A total 321 apparently healthy patient serum samples which consisted of 164 healthy adult females and 157 healthy adult males were obtained.
Reference intervals were determined by calculating the 2.5th and 97.5th percentiles of the distribution of values.
| Group | N^a | Reference Interval |
|---|---|---|
| Apparently healthy adults (≥ 22 years) | 321 | 2.44–74.9 ng/mL (3.70–113 pmol/L) |
| Apparently healthy adult females | 164 | 2.58–78.3 ng/mL (3.91–119 pmol/L) |
| Apparently healthy adult males | 157 | 2.37–70.1 ng/mL (3.59–106 pmol/L) |
Page 16
Siemens Healthcare Diagnostics
510(k) Summary
Siemens Healthcare Diagnostics, Inc
510(k) Submission – Atellica IM Tg Assay (K242981)
Page 12 of 12
Serum samples from 136 post-thyroidectomy adults were tested. Pregnant subjects and samples with detectable levels of anti-Tg were excluded from the study. The reference interval was determined by calculating the 95th percentile of the distribution of values.
| Group | N^a | Reference Interval |
|---|---|---|
| Post-thyroidectomy adults (≥ 22 years) | 136 |