(458 days)
No
The summary describes a standard immunoassay technology and does not mention any AI or ML components in the device description, intended use, or performance studies. The results are determined via a calibration curve, which is a traditional method.
No
The device is an in vitro diagnostic immunoassay used for quantitative determination of a biomarker (thyroglobulin) to aid in monitoring disease, not for direct treatment or amelioration of a condition.
Yes
The device is an immunoassay designed for the quantitative determination of thyroglobulin, which is used as an aid in monitoring for the presence of persistent, recurrent, or metastatic disease in patients with differentiated thyroid cancer. This function directly supports the diagnosis and management of a medical condition.
No
The device is an immunoassay, which is a laboratory test that uses antibodies to detect and measure specific substances. It is intended for use on cobas e immunoassay analyzers, which are hardware instruments. The description details the chemical principles of the assay and performance characteristics related to the biological sample and reagents, not solely software functionality.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Immunoassay for the in vitro quantitative determination of thyroglobulin in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory-based immunoassay method ("two-step, double antigen sandwich principle") used to analyze biological samples (serum and plasma).
- Performance Studies: The document includes detailed analytical and clinical performance studies, which are standard requirements for IVD devices to demonstrate their accuracy and reliability for diagnostic purposes.
- Predicate Device: The mention of a predicate device (K002905; Access® Thyroglobulin Reagents on the Access® Immunoassay) is common in regulatory submissions for IVDs, indicating a comparison to an already cleared IVD.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of thyroglobulin in human serum and plasma. Determination of Tg is used as an 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). The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
Product codes
MSW
Device Description
The Tg II immunoassay makes use of a two-step, double antigen sandwich principle using a biotinylated monoclonal Tg-specific antibody and monoclonal Tg-specific antibodies labeled with a ruthenium complex. The Tg II immunoassay is intended for the in vitro quantitative determination of thyroglobulin in human serum and plasma. Determination of Tg is used 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). 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
A reference range study was performed with 244 apparently healthy male subjects between 22 and 79 years of age and 219 apparently healthy female subjects between 22 and 77 years of age.
Study for the expected values obtained from a total of 127 subjects with differentiated thyroid cancer (100 female; 27 male) with no evidence of disease for 4 or more years following total/near total thyroidectomy was conducted.
A prospective, multi-center study was conducted on the cobas e 411 analyzer to assess the clinical performance of Elecsys Tg II. Samples were collected from 9 sites across the U.S. 530 samples were available for analysis.
Serum samples were collected from subjects in the longitudinal cohort within 4 - 12 weeks following total or near total thyroidectomy but before radioiodine ablation (if planned). Thyroglobulin levels were measured at 4 additional time points (approximately 6 months, 12 months, 18 months, and 24 months post-surgery/radioiodine ablation), 5 planned longitudinal visits per patient.
Samples from the cross-sectional cohort (structural disease positive) were used to increase the number of observations from patients with structural disease in the longitudinal cohort due to the low prevalence of structural disease in the longitudinal cohort. Subjects from the cross-sectional cohort had only 1 single visit.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical study:
A prospective, multi-center study was conducted on the cobas e 411 analyzer to assess the clinical performance of Elecsys Tg II.
Sample size: 530 samples
Key results:
Sensitivity: 98.91% (91/92)
Specificity: 53.42% (234/438)
Prevalence: 4.99% (23/461)
Negative Predictive Value (NPV): 99.89%
Positive Predictive Value (PPV): 10.03%
Within-laboratory precision:
Study type: Imprecision study evaluated using Elecsys reagents, samples, and controls in accordance with the CLSI document EP05-A3.
Sample size: n = 84 (2 runs per day in duplicate each for 21 days)
Site-to-site reproducibility study:
Study type: Reproducibility study conducted on 3 cobas e 411 analyzers at 3 sites using 3 lots of reagents.
Sample size: n = 150 (5 replicates per run, in a single run per day, for 5 days according to the CLSI document EP05-A3)
Limit of Blank (LoB) determination:
Study type: Determined according to CLSI EP17-A2.
Sample size: Five analyte-free samples measured in two replicates per run, six runs distributed over 4 days using three reagent lots on one analyzer.
Key results: LoB = 0.02 ng/mL
Limit of Detection (LoD) determination:
Study type: Determined according to CLSI EP17-A2.
Sample size: Five native samples with low-analyte concentration measured in two replicates per run, six runs distributed over 4 days, using three reagent lots on one analyzer.
Key results: LoD = 0.04 ng/mL
Limit of Quantitation (LoQ) determination:
Study type: Determined according to CLSI EP17-A2.
Sample size: Seven low-level human serum samples (HS) measured in five replicates with one run per day over 5 days using three reagent lots on one analyzer.
Key results: LoQ = 0.1 ng/mL
Linearity study:
Study type: Linearity study conducted on the cobas e 411 analyzer with 3 lots of reagent.
Sample size: Two native, unmodified human serum samples (low, high) mixed in different proportions.
Key results: All deviations from linearity met the specification of ±10% for values ≥0.3 ng/mL and within ±0.03 ng/mL for values
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 30, 2023
Roche Diagnostics Phil Williams Regulatory Affairs Program Manager 9115 Hague Road Indianapolis, Indiana 46250
Re: K221890
Trade/Device Name: Elecsys Tg II Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-Associated Antigen Immunological Test System Regulatory Class: Class II Product Code: MSW Dated: April 21, 2023 Received: April 21, 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
1
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) K221890
Device Name Elecsys Tg II
Indications for Use (Describe)
Immunoassay for the in vitro quantitative determination of thyroglobulin in human serum and plasma. Determination of Tg is used as an 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). The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
| 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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K221890
510(k) Summary
| Submitter Name | Roche Diagnostics | |
|---|---|---|
| Address | 9115 Hague Road | |
| Indianapolis, IN 46250 | ||
| Contact | Phil Williams | |
| Email: phil.williams@roche.com | ||
| Date Prepared | May 19, 2023 | |
| Device Trade Name | Elecsys Tg II (08906556160) | |
| Common Name | Tumor-associated antigen immunological test system | |
| Classification Name | System, Test, Thyroglobulin | |
| Regulation Number | 866.6010 | |
| Product Codes, | ||
| Regulation Numbers | MSW | |
| Legally Marketed Predicate | ||
| Devices | K002905 | |
| Access® Thyroglobulin Reagents on the Access® Immunoassay | MSW |
DEVICE DESCRIPTION SUMMARY 1.
The Tg II immunoassay makes use of a two-step, double antigen sandwich principle using a biotinylated monoclonal Tg-specific antibody and monoclonal Tg-specific antibodies labeled with a ruthenium complex. The Tg II immunoassay is intended for the in vitro quantitative determination of thyroglobulin in human serum and plasma. Determination of Tg is used 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). 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.
2. INTENDED USE/INDICATIONS FOR USE
Immunoassay for the in vitro quantitative determination of thyroglobulin in human serum and plasma. Determination of Tg is used as an aid in monitoring for the presence of persistent or
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recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy).
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
INDICATIONS FOR USE COMPARISON 3.
The Elecsys Tg II is substantially equivalent to the Access® Thyroglobulin Reagents on the Access® Immunoassay Systems. Both test systems are for the quantitative determination of thyroglobulin levels in human serum and plasma and used as an aid in the monitoring for the presence of local and metastatic thyroid tissue in patients who have thyroid cancer and have had thyroid surgery.
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TECHNOLOGICAL COMPARISON 4.
| Item | Predicate
(Beckman Access, K002905) | Candidate Device
(Elecsys Tg II) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Principle | The Access Thyroglobulin assay is a
simultaneous one-step immunoenzymatic
("sandwich") assay.
A sample is added to a reaction vessel,
along with a biotinylated mixture of four
monoclonal Tg antibodies, streptavidin
coated paramagnetic particles, and
monoclonal anti-Tg antibody alkaline
phosphatase conjugate. The biotinylated
antibodies and the serum or plasma
thyroglobulin binds to the solid phase,
while the conjugate antibody reacts with
a different antigenic site on the
thyroglobulin molecule. After incubation
in a reaction vessel, materials bound to
the solid phase are held in a magnetic
field while unbound materials are washed
away. Then, the chemiluminescent
substrate Lumi-Phos* 530 is added to the
vessel and light generated by the reaction
is measured with a luminometer. The
light production is directly proportional
to the concentration of thyroglobulin in
the sample. The amount of analyte in the
sample is determined from a stored,
multi-point calibration curve. | Sandwich principle. Total duration of
assay: 18 minutes.
• 1st incubation: Tg from 35 µL of
sample, a biotinylated monoclonal
Tg-specific antibody and monoclonal
Tg-specific antibodies labeled with a
ruthenium complex a) react to form a
sandwich complex.
• 2nd incubation: After addition of
streptavidin-coated microparticles, the
complex becomes bound to the solid
phase via interaction of biotin and
streptavidin.
• The reaction mixture is aspirated
into the measuring cell where the
microparticles are magnetically
captured onto the surface of the
electrode. Unbound substances are
then removed with ProCell/ProCell
M. Application of a voltage to the
electrode then induces
chemiluminescent emission which is
measured by a photomultiplier.
• 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
a) Tris(2,2'-bipyridyl)ruthenium(II)-
complex (Ru(bpy) ) |
| Instrument | Access® Immunoassay Systems | cobas e immunoassay analyzers |
| Item | Predicate
(Beckman Access, K002905) | Candidate Device
(Elecsys Tg II) |
| Reagent
Composition | R1: Access Thyroglobulin Reagent Test
Packs: Cat# 33860. 100 determinations,
50 tests/pack
R1a: Dynabeads Paramagnetic particles
coated with streptavidin, suspended in a
Tris-buffered saline, surfactant, bovine
serum albumin (BSA) 1.0 ng/mL (corresponding to ATA "Biochemical Incomplete Response"), the probability of structural disease was much higher than the probability of structural disease for Tg concentrations