(382 days)
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No
The description details a standard immunoassay using electrochemiluminescence and a calibration curve, with no mention of AI or ML algorithms for data analysis or interpretation.
No
Explanation: The device is an immunoassay intended for in vitro quantitative determination of antibodies to thyroglobulin, used as an aid in detecting autoimmune thyroid diseases. It is a diagnostic device, providing information for diagnosis, rather than directly treating or preventing a disease.
Yes
Explanation: The device is used for the "quantitative determination of antibodies to thyroglobulin in human serum and plasma," and this determination is "used as an aid in the detection of autoimmune thyroid diseases in conjunction with other laboratory and clinical findings," which indicates a diagnostic purpose.
No
The device description explicitly states it is an "immunoassay" and makes use of a "competitive test principle using biotinylated human antigen and monoclonal human anti-Tg antibodies labeled with a ruthenium complex." This describes a chemical and biological reagent-based test, not a software-only device. It also mentions use on a specific hardware analyzer (cobas e 411).
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma." The term "in vitro" is a key indicator of an IVD.
Furthermore, the description of the device and its function (measuring antibodies in human samples using an immunoassay on a specific analyzer) aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg autoantibodies determination is used as an aid in the detection of autoimmune thyroid diseases in conjunction with other laboratory and clinical findings.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzer.
Product codes (comma separated list FDA assigned to the subject device)
JZO
Device Description
The Elecsys Anti-Tg immunoassay makes use of a competitive test principle using biotinylated human antigen and monoclonal human anti-Tg antibodies labeled with a ruthenium complex. The Elecsys Anti-Tg immunoassay is intended for the quantitative determination of antibodies to thyroglobulin in human serum and plasma. It is intended for use on the cobas e immunoassay analyzers.
Results are determined via a calibration curve which is instrument-specifically generated by 2 point calibration and a master curve provided via the reagent barcode or e barcode.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Study (Repeatability and Intermediate Precision): Measurements were conducted for the updated Elecsys Anti-Tg to evaluate repeatability (within-run precision) and the intermediate precision (within-laboratory precision) according to the CLSI guideline EP05-A3. All predefined acceptance criteria were met.
Precision Study (Lot-to-lot Reproducibility): Measurements were conducted according to CLSI guideline EP05-A3 to evaluate Lot-to-Lot Reproducibility using three reagent lots. All predefined acceptance criteria were met.
Analytical Sensitivity (Limit of Blank (LoB)): Determined according to CLSI EP17-A2. The LoB claim in the labeling will be set to 9 IU/mL.
Analytical Sensitivity (Limit of Detection (LoD)): Determined according to CLSI EP17-A2. The LoD claim in the labeling will be set to 10 IU/mL.
Analytical Sensitivity (Limit of Quantitation (LoQ)): Determined according to CLSI EP17-A2. The LoQ claim in the labeling will be set to 15 IU/mL.
Linearity Study: Assessed according to CLSI EP06-Ed2, study design B, using weighted linear regression analysis. Six dilution series, using native human serum samples and sample pools, were measured on the cobas e 411 analyzer. Linearity was confirmed to support the measuring range of 15 - 4000 IU/mL.
Endogenous Interferences Study: Evaluated six endogenous substances for potential interference. All predefined acceptance criteria were met. Proposed labeling claims: Biotin ≤ 1200 ng/mL, Lipemia (Intralipid) ≤ 2000 mg/dL, Hemoglobin ≤ 600 mg/dL for sample concentrations ≤ 115 IU/mL, Bilirubin ≤ 66 mg/dL, Rheumatoid Factor ≤ 300 IU/mL, Tg ≤ 100 ng/mL.
Analytical Specificity/Cross-Reactivity Study: Conducted to evaluate potential cross-reactivity with anti-TPO. No cross-reaction with Anti-TPO was detected.
Exogenous Interferences Study: Evaluated 17 commonly and 14 specially used pharmaceutical compounds. The predefined acceptance criteria were met for all drugs tested, and no interference was observed.
Sample Matrix Comparison Study: Determined the effect on quantitation of analyte in the presence of anticoagulants with Anti-Tg by comparing values from native human serum samples and sample pools drawn into serum, K2-EDTA, and K3-EDTA plasma primary tubes. Results were within specification and support the use of Serum collected using standard serum tubes or tubes containing separating gel, K2-EDTA, and K3-EDTA plasma.
Method Comparison to Predicate: Performed using the Elecsys Anti-Tg updated assay and the Elecsys Anti-Tg current assay, using a total of 129 human serum samples. Sample concentrations were between 23.1 and 3609 IU/mL.
Results: Linear Regression y = 0.905x + 48.0, r = 0.990. Passing Bablok y = 0.974x + 1.72, τ = 0.930.
Reagent Stability (On-board): Tested on one cobas e 411 analyzer. Elecsys Anti-Tg reagent kits can be stored on-board for up to 42 days (6 weeks). New calibration recommended every 7 days.
Reagent Stability (After First Opening): Tested on one cobas e 411 analyzer. Elecsys Anti-Tg reagent kits can be used for up to 42 days (6 weeks) when stored at 2-8°C.
Calibration Stability (Lot Calibration): Tested on one cobas e 411 analyzer. Calibration of a reagent lot is recommended every 28 days (1 month).
Calibration Stability (On-board Calibration): Tested on one cobas e 411 analyzer. Elecsys Anti-Tg reagent kits can be stored on board for up to 7 days without a new calibration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LoB: 9 IU/mL
LoD: 10 IU/mL
LoQ: 15 IU/mL
Linearity: 15 - 4000 IU/mL
Endogenous Interference thresholds: Biotin ≤ 1200 ng/mL, Lipemia (Intralipid) ≤ 2000 mg/dL, Hemoglobin ≤ 600 mg/dL (for sample concentrations ≤ 115 IU/mL), Bilirubin ≤ 66 mg/dL, Rheumatoid Factor ≤ 300 IU/mL, Tg ≤ 100 ng/mL.
Method Comparison Regression values: y = 0.905x + 48.0, r = 0.990 (Linear Regression); y = 0.974x + 1.72, τ = 0.930 (Passing Bablok).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Roche Diagnostics Elecsys Anti-Tg (K053426)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.5870 Thyroid autoantibody immunological test system.
(a)
Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.
September 15, 2023
Roche Diagnostics Phil Williams Regulatory Affairs Consultant 9115 Hague Road Indianapolis, Indiana 46250
Re: K222610
Trade/Device Name: Elecsys Anti-Tg Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid Autoantibody Immunological Test System Regulatory Class: Class II Product Code: JZO Dated: Mav 19, 2023 Received: May 19, 2023
Dear Phil Williams:
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. 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 located 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.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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
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Indications for Use
510(k) Number (if known) K222610
Device Name Elecsys Anti-Tg
Indications for Use (Describe)
Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg autoantibodies determination is used as an aid in the detection of autoimmune thyroid diseases in conjunction with other laboratory and clinical findings.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzer.
| 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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Elecsys Anti-Tg
510(k) Summary
| Submitter Name | Roche Diagnostics |
|---|---|
| Address | 9115 Hague Road |
| P.O. Box 50416 | |
| Indianapolis, IN 46250-0457 | |
| Contact | Phil Williams |
| Phone: 317-209-5478 | |
| Email: phil.williams@roche.com | |
| Date Prepared | August 25, 2022 |
| Proprietary Name | Elecsys Anti-Tg |
| Common Name | Thyroid autoantibody immunological test system |
| Classification Name | System, Test, Thyroid Autoantibody |
| Product Codes, | |
| Regulation Numbers | JZO, 21 CFR 866.5870 |
| Predicate Devices | Roche Diagnostics Elecsys Anti-Tg (K053426) |
| Establishment Registration | Roche Diagnostics GmbH Mannheim, Germany: 9610126 |
| Roche Diagnostics GmBH Penzberg, Germany: 9610529 | |
| Roche Diagnostics Indianapolis, IN United States: 1823260. |
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1. DEVICE DESCRIPTION
The Elecsys Anti-Tg immunoassay makes use of a competitive test principle using biotinylated human antigen and monoclonal human anti-Tg antibodies labeled with a ruthenium complex. The Elecsys Anti-Tg immunoassay is intended for the quantitative determination of antibodies to thyroglobulin in human serum and plasma. It is intended for use on the cobas e immunoassay analyzers.
Results are determined via a calibration curve which is instrument-specifically generated by 2 point calibration and a master curve provided via the reagent barcode or e barcode.
1.1. Reagents
The reagent working solutions include:
Rack Pack (kit placed on the analyzer)
- M: Streptavidin-coated microparticles .
- R1: Tg~biotin .
- R2: Anti Tg-Ab~Ru(bpy) .
INDICATIONS FOR USE 2.
Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg autoantibodies determination is used as an aid in the detection of autoimmune thyroid diseases in conjunction with other laboratory and clinical findings.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzer.
3. TECHNOLOGICAL CHARACTERISTICS
The following table compares the Elecsys Anti-Tg with its predicate device, Roche Elecsys Anti-Tg (K053426).
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| Feature | Candidate Device
Elecsys Anti-Tg | Predicate Device
Roche Elecsys Anti-Tg (K053426) |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoassay for the in vitro
quantitative determination of
antibodies to thyroglobulin in
human serum and plasma. The
anti-Tg autoantibodies
determination is used as an aid in
the detection of autoimmune
thyroid diseases in conjunction
with other laboratory and clinical
findings.
The electrochemiluminescence
immunoassay "ECLIA" is
intended for use on cobas e 411
immunoassay analyzer. | Immunoassay for the in vitro
quantitative determination of
antibodies to thyroglobulin in human
serum and plasma. The anti-Tg
determination is used as an aid in the
detection of autoimmune thyroid
diseases.
The electrochemiluminescence
immunoassay "ECLIA" is intended
for use on Elecsys and cobas e
immunoassay analyzers. |
| Assay Method | Competitive | Same |
| Test type | Quantitative | Same |
| Detection Method | Electrochemiluminescence
"ECLIA" | Same |
| Application Time | 18 minute | Same |
| Assay protocol | Sample + R1, 1st incubation
R2 + Beads, 2nd incubation | Same |
| Handling of R1 and R2 | Liquid, ready to use | Same |
| Sample Type/Matrix | Human serum, plasma | Same |
| Sample Anticoagulants | K2/K3-EDTA | Sodium heparin, K2/K3-EDTA |
| Pipetting volume sample | 10 μL | Same |
| Calibrator | Anti-Tg CalSet | Included in Test Kit as Anti-Tg
calibrator 1 and Anti-Tg calibrator 2 |
| Calibration Method | 2-point calibration | Same |
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| Feature | Candidate Device
Elecsys Anti-Tg | Predicate Device
Roche Elecsys Anti-Tg (K053426) |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Calibration Interval | Calibration must be performed
once per reagent lot using fresh
reagent (i.e. not more than 24
hours since the reagent kit was
registered on the analyzer).
Calibration interval may be
extended based on acceptable
verification of calibration by the
laboratory.
Renewed calibration is
recommended as follows:
• after 1 month (28 days) when
using the same reagent lot
• after 7 days (when using the
same reagent kit on the analyzer)
• as required: e.g. quality control
findings outside the defined limits | Calibration must be performed once
per reagent lot using fresh reagent (i.e.
not more than 24 hours since the
reagent kit was registered on the
analyzer).
Renewed calibration is recommended
as follows:
• after 1 month (28 days) when using
the same reagent lot
• after 7 days (when using the same
reagent kit on the analyzer)
• as required: e.g. quality control
findings outside the defined limits |
| Controls | PreciControl ThyroAB | Included in Test Kit as PreciControl
Anti-Tg 1 and PreciControl Anti-Tg 2 |
| Traceability/Standardization | Standardized against the NIBSC
(National Institute for Biological
Standards and Control) 65/93
Standard | Same |
| Reagent Stability | • unopened at 2-8 °C: up to the
stated expiration date
• after opening at 2-8 °C: 6 weeks
• on the analyzer: 6 weeks | Same |
| Measuring Range | 15 - 4000 IU/mL | 10 - 4000 IU/mL |
| Biotin Tolerance |