(90 days)
Not Found
No
The summary describes a standard immunoassay and analyzer, with no mention of AI or ML in the device description, intended use, or performance studies. The performance studies focus on analytical characteristics typical of laboratory assays.
No.
This device is an in vitro diagnostic immunoassay used to quantify autoantibodies associated with Graves' disease, which aids in assessment rather than treatment.
Yes
This device is an immunoassay intended for the in vitro quantitation of autoantibodies to TSH receptor in human serum, which is used in the assessment of patients suspected of Graves' disease. By providing quantitative information about a patient's autoantibody levels to aid in diagnosis, it functions as a diagnostic device.
No
The device is an immunoassay kit intended for use on a specific hardware analyzer (cobas e 601). It is a reagent-based test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "Immunoassay for the in vitro quantitation of autoantibodies to thyroid stimulating hormone (TSH) receptor in human serum". The phrase "in vitro" is a key indicator of an IVD. It also specifies the use of human serum, a biological sample.
- Device Description: The description reiterates "used for the in vitro quantitative determination of autoantibodies to TSHR receptor in human serum".
- Technology: The use of "electrochemiluminescence immunoassay (ECLIA)" is a common technology used in IVD assays to measure substances in biological samples.
- Sample Type: The device is designed to analyze "human serum".
- Purpose: The purpose is to "quantitation of autoantibodies" and is used in the "assessment of patients suspected of Graves' disease". This is a diagnostic purpose performed on a biological sample outside of the body.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitation of autoantibodies to thyroid stimulating hormone (TSH) receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti-TSH receptor determination is used in the assessment of patients suspected of Graves' disease (autoimmune hyperthyroidism).
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e 601 immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JZO, JIT, JJX
Device Description
The Elecsys Anti-TSHR is used for the in vitro quantitative determination of autoantibodies to TSHR receptor in human serum using a human thyroid stimulating monoclonal antibody. It is intended for use on the cobas e 601 immunoassay analyzer. The cobas e family of analyzers uses electrochemiluminescence immunoassay "ECLIA" technology.
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
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
- Repeatability and Intermediate Precision: Precision evaluated on one cobas e 601 immunoassay analyzer with one reagent lot. Protocol: 2 replicates per run, 2 runs/day for 21 days. Samples: human serum pools (HS 1-4) and spiked human serum (HS 5). All samples met predetermined acceptance criterion.
- Lot-to-Lot Reproducibility: Evaluated on one cobas e 601 analyzer using three reagent lots. Protocol: 2 replicates of each human serum per run, 2 runs/day (n = 28 determinations per lot). Calculated SDs and CVs were comparable to the single lot study.
Analytical Sensitivity:
- Limit of Blank (LoB): Determined according to CLSI EP17-A2. Three reagent lots on one cobas e 601 analyzer, six runs on ≥ three days, with five blank samples with two replicates each per run (total 60 determinations). LoB claim: 0.5 IU/L.
- Limit of Detection (LoD): Determined according to CLSI EP17-A2. Three reagent lots on one cobas e 601 analyzer, six runs on ≥ three days, with five low analyte samples with two replicates each per run (60 replicates per sample per reagent lot). LoD claim: 0.8 IU/L.
- Limit of Quantitation (LoQ): Determined according to CLSI EP17-A2. Three reagent lots on one cobas e 601 analyzer for 5 days, one run per day (25 replicates per sample per reagent lot). LoQ claim: 1.1 IU/L.
Linearity/Assay Reportable Range:
- Conducted according to CLSI guideline EP06-A. Three high analyte human serum samples diluted with anti-TSHR free serum to prepare 14 concentrations. Samples measured in triplicate within a single run. Linearity confirmed in the range from 0.8 to 40.0 IU/L, with all deviations within predetermined acceptance criteria.
High Dose Hook Effect:
- Not Applicable
Human Anti-Mouse Antibodies (HAMA):
- Not susceptible to interference from HAMA.
Endogenous Interference:
- Evaluated for Biotin, Hemolysis, Bilirubin, Lipemia, and Rheumatoid Factors (RF). Samples spiked with interfering substances and compared to isotonic NaCl solution. Recovery calculated by comparison to reference. Claims in package insert: Biotin
§ 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 contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 27, 2020
Roche Diagnostics Reanna Toney Principal, Regulatory Affairs 9115 Hague Road Indianapolis, Indiana 46250
Re: K193313
Trade/Device Name: Elecsys Anti-TSHR Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid autoantibody immunological test system Regulatory Class: Class II Product Code: JZO Dated: November 26, 2019 Received: November 29, 2019
Dear Reanna Toney:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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,
Carolina Kagan, M.Sc. Acting Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K193313
Device Name Elecsys Anti-TSHR
Indications for Use (Describe)
Immunoassay for the in vitro quantitation of autoantibodies to thyroid stimulating hormone (TSH) receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti-TSH receptor determination is used in the assessment of patients suspected of Graves' disease (autoimmune hyperthyroidism).
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e 601 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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Elecsys Anti-TSHR 510(k) Summary K193313
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k).
The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the Elecsys Anti-TSHR.
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| Submitter Name | Roche Diagnostics |
|---|---|
| Address | 9115 Hague Road |
| P.O. Box 50416 | |
| Indianapolis, IN 46250-0457 | |
| Contact | Reanna Toney |
| Phone: (317) 521-4516 | |
| FAX: (317) 521-2324 | |
| Email: reanna.toney@roche.com |
Secondary Contact: Tammy Dean
Phone: (317) 521-3978
FAX: (317) 521-2324
Email: tammy.dean@roche.com |
| Date Prepared | February 26, 2020 |
| Proprietary Name | Elecsys Anti-TSHR
CalSet Anti-TSHR
PreciControl ThyroAB |
| Common Name | anti-TSHR |
| Classification Name | System, Test, Thyroid Autoantibody
Calibrator, Secondary
Single (specified) analyte controls (assayed and unassayed) |
| Product Codes,
Regulation Numbers | JZO, 21 CFR 866.5870
JIT, 21CFR862.1150, EXEMPT
JJX, 21CFR862.1660, EXEMPT |
| Predicate Devices | Elecsys Anti-TSHR Immunoassay (K080092) |
| Establishment Registration | For the Elecsys Anti-TSHR, the establishment registration number for Roche
Diagnostics GmbH in Mannheim, Germany is 9610126, and for Penzberg,
Germany, 9610529. The establishment registration number for Roche
Diagnostics in the United States is 1823260 |
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1. DEVICE DESCRIPTION
The Elecsys Anti-TSHR is used for the in vitro quantitative determination of autoantibodies to TSHR receptor in human serum using a human thyroid stimulating monoclonal antibody. It is intended for use on the cobas e 601 immunoassay analyzer. The cobas e family of analyzers uses electrochemiluminescence immunoassay "ECLIA" technology.
1.1. Reagents
The reagent working solutions include:
Reagent rackpack (kit placed on the analyzer)
- . Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: M Streptavidin-coated microparticles 0.72 mg/mL; preservative.
- . Buffer solution (gray cap), 1 bottle, 7 mL: Phosphate buffer 20 mmol/L, pH 7.4; R1 stabilizers, preservative.
- . Anti TSHR~Ru(bpy) (black cap), 1 bottle, 7 mL: Monoclonal anti TSHR R2 antibody M22 (human) labeled with ruthenium complex approximately 0.3 mg/L; phosphate buffer 20 mmol/L, pH 7.4; stabilizers, preservative.
Pretreatment rackpack
- . PT1 Pretreatment buffer solution (black cap), 1 bottle, 4 mL: Phosphate buffer 20 mmol/L, pH 7.4; stabilizers, preservative.
- PT2 Empty bottle (white cap) for pretreatment reagent (PTR) reconstituted with . pretreatment buffer (PTB).k Pack
- Pretreatment reagent, pTSHR-anti-pTSHR-Ab~biotin complex (white cap), ● PTR 1 bottle for 4 mL of PTB: Phosphate buffer 40 mmol/L, pH 7.2; stabilizers.
- . Pretreatment buffer (white cap), 1 bottle, 5 mL:Reconstitution medium for PTR; PTB phosphate buffer 10 mmol/L, pH 7.2; stabilizer.
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2. INDICATIONS FOR USE
Immunoassay for the in vitro quantitative determination of autoantibodies to thyroid stimulating hormone (TSH) receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti-TSH receptor determination is used in the assessment of patients suspected of Graves' disease (autoimmune hyperthyroidism).
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzers.
3. TECHNOLOGICAL CHARACTERISTICS
The following table lists the technical characteristics from the Elecsys Anti-TSHR method sheet.
| Table 1: Elecsys Anti-TSHR Technical Characteristics | ||
|---|---|---|
| Feature | Elecsys Anti-TSHR |
|---|---|
| Technology | ECLIA |
| Application/test time | 18 minutes |
| Instrument platform | cobas e 601 immunoassay analyzers |
| Test format | Competition |
| Test type | Quantitative |
| Assay protocol | Sample+PT1+PT2, incubation, +R1, incubation, + R2 |
| Handling of R1 and R2 | Liquid, Ready for use |
| Sample Type/Matrix | serum |
| Measuring Range | 0.8 - 40 IU/L |
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Table 2: Substantial Equivalency
| Item | Elecsys Anti-TSHR
(K080092) | Elecsys Anti-TSHR
(K193313) |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary name | Elecsys Anti-TSHR Immunoassay | Elecsys Anti-TSHR |
| Catalog number | 04388780 160 | 08496609 190 |
| Intended use | Immunoassay for the in vitro
quantitative determination of
autoantibodies to TSH receptor in
human serum using a human thyroid
stimulating monoclonal antibody. The
anti-TSH receptor determination is
used in the assessment of patients with
suspect Graves' disease (autoimmune
hyperthyroidism).
The electrochemiluminescence
immunoassay "ECLIA" is intended for
use on Elecsys and cobas e
immunoassay analyzers. | Immunoassay for the in vitro quantitative
determination of autoantibodies to
thyroid stimulating hormone (TSH)
receptor in human serum using a human
thyroid stimulating monoclonal antibody.
The anti-TSH receptor determination is
used in the assessment of patients
suspected of Graves' disease
(autoimmune hyperthyroidism).
The electrochemiluminescence
immunoassay “ECLIA" is intended for
use on the cobas e 601 immunoassay
analyzer. |
| Technology | ECLIA | Same |
| Test format | Competitive | Same |
| Test type | Quantitative | Same |
| Assay protocol | sample+PT1+PT2, incubation, +R1,
incubation, +beads+R2, incubation | Same |
| Pipetting volume sample | 50 µL | Same |
| Pretreatment buffer solution (PT1) | 10 µL | Same |
| Pretreatment reagent buffer (PT2) | 20 µL | Same |
| Pipetting volume M (beads) | 30 µL | Same |
| Pipetting volume R1 | 40 µL | Same |
| Pipetting volume R2 | 50 µL | Same |
| Handling of PT1 | Liquid, ready to use | Same |
| Handling of PT2 | Mix pretreatment reagent (PTR) +
4 mL of pretreatment buffer (PTB) | Same |
| Handling of R1 and R2 | Liquid, ready to use | Same |
| Measuring range | 0.800 - 40.0 IU/L | Same |
| Biotin tolerance | Up to 10 ng/mL | Up to 600 ng/mL |
| | | |
| Expected values | In an external study using the Elecsys
Anti-TSHR assay on samples from
436 apparently healthy individuals,
210 patients with thyroid diseases*
without diagnosis of Graves' disease,
and 102 patients with untreated
Graves' disease an optimal cutoff of
1.75 IU/L was determined. At this
cutoff the sensitivity was calculated at
96 % and the specificity at 99 %. | In an external study using the Elecsys
Anti-TSHR assay on samples from
436 apparently healthy individuals, 210
patients with thyroid diseases*
without diagnosis of Graves' disease,
and 102 patients with untreated
Graves' disease an optimal cutoff of 1.75
IU/L was determined. Assay values less
than or equal to the cut-off, 1.75 IU/L,
are considered negative. Values greater
than the cut-off are considered positive.
At this cutoff the sensitivity was
calculated at 96 % and the specificity at
99 %. |
| | Buffer composition R1 | Phosphate buffer 20 mmol/L |
| | Biotinylated antibody | MAKM-4E31-IgG-Bi
(DDS* mono) |
| | Buffer composition R2 | Phosphate buffer 20 mmol/L |
| | | - |
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4. NON-CLINICAL PERFORMANCE EVALUATION
The non-clinical performance studies for Elecsys Anti-TSHR are summarized below.
Precision 4.1.
Repeatability and Intermediate Precision 4.1.1.
Precision of the Elecsys Anti-TSHR assay was evaluated on one cobas e 601 immunoassay analyzer with one reagent lot. The protocol consisted of testing 2 replicates of each control level and human sera (HS) per run, 2 runs per day for 21 days. The samples were run in randomized order on the analyzer. Human serum samples used were native human serum pools (human serum 1-4) and spiked human serum (human serum 5). Repeatability and Intermediate imprecision were calculated according to EP05-A3. All samples met the predetermined acceptance criterion.
| Repeatability | Intermediate Precision | ||||
|---|---|---|---|---|---|
| Mean | SD | CV | SD | CV | |
| Sample | IU/L | IU/L | % | IU/L | % |
| Sample 1 | 1.41 | 0.105 | 7.5 | 0.129 | 9.1 |
| Sample 2 | 1.87 | 0.140 | 7.5 | 0.161 | 8.6 |
| Sample 3 | 1.99 | 0.114 | 5.7 | 0.144 | 7.2 |
| Sample 4 | 22.7 | 0.252 | 1.1 | 0.347 | 1.5 |
| Sample 5 | 37.5 | 0.298 | 0.8 | 0.505 | 1.3 |
| PC ThyroAB 1 | 4.42 | 0.145 | 3.3 | 0.178 | 4.0 |
| PC ThyroAB 2 | 18.1 | 0.342 | 1.9 | 0.397 | 2.2 |
The following table summarizes the precision data for Elecsys Anti-TSHR.
4.1.2. FDA requested Lot-to-Lot Reproducibility
Lot-to-lot reproducibility of the Elecsys Anti-TSHR assay was evaluated on one cobas e 601 analyzer using three reagent lots. A precision study was performed with 2 replicates of each human sera (HS) per run, 2 runs per day (n = 28 determinations per lot, 3x7x2x2 measurements for each sample). The samples were run in randomized order on the analyzer. Human serum samples used were human serum pools (human serum 1-4) as well as spiked human serum (human serum 5).
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Repeatability, Between-Run, Between-Day, Between-Lot and Total imprecision were calculated according to EP05-A3. Calculated SD´s and CV´s for the multiple lot (reproducibility) study are comparable to those of the single lot (intermediate) precision study over 21 days using only one reagent lot indicating that the updated assay performs consistently from lot to lot.
4.2. Analytical Sensitivity
4.2.1. Limit of Blank (LoB)
LoB of the Elecsys Anti-TSHR was determined according to CLSI EP17-A2. The experimental design included three reagent lots evaluated on one cobas e 601 analyzer, six runs on ≥ three days, with five blank samples with two replicates each per run. In total, 60 determinations for analyte free samples have been obtained. All lots met the predetermined acceptance criterion. The LoB claim in the labeling will be set to 0.5 IU/L.
4.2.2. Limit of Detection (LoD)
LoD of the Elecsys Anti-TSHR was determined according to CLSI EP17-A2. The experimental design included three reagent lots evaluated on one cobas e 601 analyzer, six runs on ≥ three days, with five low analyte samples with two replicates each per run. Sixty (60) replicates per sample per reagent lot were run. All lots met the predetermined acceptance criterion. The LoD claim in the labeling will be set to 0.8 IU/L.
Limit of Quantitation (LoQ) 4.2.3.
LoQ of the Elecsys Anti-TSHR was determined according to CLSI EP17-A2. The experimental design included three reagent lots evaluated on one cobas e 601 analyzer for 5 days, one run per day. There were 25 replicates per sample per reagent lot. All lots met the predetermined acceptance criterion. The LoQ claim in the labeling will be set to 1.1 IU/L.
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4.3. Linearity/Assay Reportable Range
The linearity study was conducted to demonstrate that there exists a mathematically verified linear relationship between the determined values and the true concentrations across the claimed measuring range. The study was performed according to CLSI guideline EP06-A.
Three high analyte human serum samples (serum pools) were diluted with anti-TSHR free serum. 14 concentrations (13 dilutions) throughout the measuring range were prepared. Samples were measured in triplicate within a single run.
The linearity data were analyzed with regards to linear, quadratic and cubic polynomials according to CLSI EP6-A. In a first step, a linearity check was performed with a first order (linear) regression and then with higher order models (quadratic and cubic). If a first order polynomial gives the best fit, the tested measuring range is linear. If a better fit is obtained with a 2nd or 3rd order polynomial, the difference between this polynomial and the 1st order polynomial is calculated. The difference must be within specification across the entire measuring range.
All deviations were within predetermined acceptance criteria. Linearity was confirmed in the range from 0.8 to 40.0 IU/L.
4.4. High Dose Hook Effect
Not Applicable
4.5. Human Anti-Mouse Antibodies (HAMA)
The Elecsys Anti-TSHR is not susceptible to interference from Human Anti-Mouse Antibodies (HAMA).
4.6. Endogenous Interference
The purpose of this study was to evaluate endogenous substances for potential interference with the parameters measured with the Elecsys Anti-TSHR on the cobas e 601 analyzer.
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4.6.1. Biotin
One aliquot of each serum sample was spiked with the interfering substance, another aliquot was spiked with the same volume of isotonic NaCl solution (dilution pool). The interfering pool was then diluted into the dilution pool. The recovery for each sample was calculated by comparison to the reference (unspiked) sample. The claim of package insert has been set to