(157 days)
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 disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.
The ELECSYS® Anti-Tg Assay a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection.
Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code.
The provided text describes the ELECSYS® Anti-Tg Assay, an immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma, used as an aid in detecting autoimmune thyroid diseases.
This submission is a 510(k) premarket notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on demonstrating comparable performance to an existing device rather than establishing new acceptance criteria based on a standalone clinical study. Therefore, the information typically requested for AI/ML device studies (e.g., sample size for test sets, number of experts for ground truth, MRMC studies) is not directly applicable in the same way to this conventional immunoassay submission.
Instead, the "acceptance criteria" here refer to the performance characteristics that demonstrate substantial equivalence to the predicate device. The "study" proving the device meets these criteria is the comparative performance testing against the predicate device.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" are implied by the performance characteristics of the predicate device, which the new device aims to be substantially equivalent to. The robust performance data from the predicate device serves as the benchmark.
| Feature | Acceptance Criteria (Implied by Predicate Device) | Reported Device Performance (ELECSYS® Anti-Tg) |
|---|---|---|
| Measuring range | 0 – 3000 IU/ml | 10 – 4000 IU/ml |
| Expected values | Nondetectable to 40 IU/ml (95th percentile) | Up to 115 IU/ml (95th percentile) |
| Intra-assay precision (%CV) | Ranges from 3.2% to 4.9% | Ranges from 4.6% to 5.6% |
| Total precision (%CV) | Ranges from 4.6% to 5.8% | Ranges from 5.9% to 8.7% |
| Analytical sensitivity | 2.2 IU/ml | < 10 IU/ml |
| Interference | No significant effect from bilirubin, hemolysis | No interference from icterus, hemolysis, lipemia, biotin, rheumatoid factor |
| On-board stability | N/A (not reported for predicate) | 6 weeks (Elecsys® 2010 / E170, 1010), Up to 20 hr. opened in total |
| Calibration frequency | Every 2 weeks | (Varies by instrument, 1 month, 7 days, 3 days, or per lot) |
Note on "Acceptance Criteria": For a 510(k) submission of an in vitro diagnostic (IVD) device, the primary "acceptance criterion" is almost always demonstrated substantial equivalence to a predicate device. This means the new device must perform comparably for its intended use, with any differences not raising new questions of safety or effectiveness. The data presented aims to show this comparability rather than meeting a pre-defined numerical performance target in isolation, as might be seen for a novel device undergoing a PMA.
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: For reproducibility (precision) studies, the document states measurements were performed "five or six times daily for 10 days (n = 59 or 60); intra-assay precision on E170, n = 21." This refers to the number of replicates for specific samples, not the number of unique patient samples in a broad test set. The document does not specify a separate "test set" sample size for overall performance evaluation (e.g., comparing results across a range of patient samples from the new device vs. the predicate). This is typical for equivalence submissions where a full clinical trial with a defined test set and ground truth is not required.
- Data Provenance: The document states "pooled human sera and commercial controls" were used for reproducibility testing. The country of origin is not specified, and the study is prospective in nature, as it involved actively collecting and analyzing samples with the new device and controls.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission for a quantitative immunoassay. The "ground truth" for an immunoassay like this is typically established by the quantitative measurement of antibodies to thyroglobulin, often calibrated against international standards (e.g., NIBSC 65/93 Standard, as stated for both devices). Expert consensus or human reader adjudication (as used in imaging studies) is not relevant for establishing the "ground truth" of an antibody concentration.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. Adjudication methods like 2+1 refer to expert review processes, which are not relevant for establishing the "ground truth" of a quantitative immunoassay measurement.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is an immunoassay device, not an AI/ML-driven diagnostic imaging device that involves human readers. Therefore, an MRMC study is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, by definition of the device. The ELECSYS® Anti-Tg Assay is a fully automated immunoassay performed on an analyzer. Its performance is entirely "standalone" in the sense that it provides a quantitative result without direct human intervention in the measurement process (though humans operate and interpret the analyzer). It is not an AI algorithm but a laboratory test.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is the quantitative concentration of antibodies to thyroglobulin as measured by a highly characterized method and calibrated against an international reference standard (NIBSC 65/93 Standard). It is not established by expert consensus, pathology, or outcomes data, as those are typically used for qualitative or diagnostic decision-making ground truth.
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The sample size for the training set:
- The document does not explicitly mention a "training set" in the context found in AI/ML algorithms. For immunoassay development, there are often various sets of samples used during assay optimization and verification (e.g., for linearity, accuracy, limits of detection). The specific sample numbers for these developmental phases are not detailed in this 510(k) summary, as the focus is on a comparison to the predicate.
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How the ground truth for the training set was established:
- As with point 7, the concept of a "training set" with an associated "ground truth" in the AI/ML sense is not directly applicable to this conventional immunoassay. The development process for an immunoassay involves rigorous analytical validation, with "ground truth" implicitly defined by the known characteristics of calibrators, controls, and reference methods used during development and validation.
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*020672
510(k) Summary - ELECSYS® Anti-Tg on ELECSYS® Immunoassay Analyzers
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|---|---|
| Submitter name, address, contact | Roche Diagnostics Corporation9115 Hague RdIndianapolis IN 46250(317) 521-3831Contact person: Sherri L. CoenenDate prepared: February 27, 2002 |
| Device Name | Proprietary name: ELECSYS® Anti-Tg AssayCommon name: Antibodies to thyroglobulin (Anti-Tg)Classification name: Thyroid autoantibody immunological test system |
| Device description | The ELECSYS® Anti-Tg Assay a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection.Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code. |
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| Intended use | Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. |
|---|---|
| Indication for use | The Anti-Tg determination is used as an aid in the detection of autoimmune thyroid diseases. |
| Substantial equivalence | The ELECSYS Anti-Tg test is equivalent to other devices legally marketed in the United States. We claim equivalence to the DPC Immulite 2000 Anti-TG AB (K991094). |
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The following table compares the ELECSYS® Anti-Tg, with the Predicate Substantial equivalence -Devices. similarities
| Feature | New DeviceELECSYS Anti-Tg | Predicate DeviceImmulite 2000 Anti-TG Ab |
|---|---|---|
| Intended use | Immunoassay for the in vitrodetermination of antibodies tothyroglobulin in human serumand plasma. The anti-Tgdetermination is used as an aidin the detection of autoimmunethyroid diseases. Theelectrochemiluminescenceimmunoassay “ECLIA” isintended for use on the RocheElecsys 1010/2010 andModular Analytics E170immunoassay analyzers. | For in vitro diagnostic use withthe Immulite 2000 analyzer –for the quantitativemeasurement of autoantibodiesto thyroglobulin (TG) in serumEDTA and heparinizedplasma, as an aid in the clinicaldiagnosis of thyroid diseases. |
| Sample type | Human serumHuman plasma treated withsodium heparin, or K2/K3-EDTA | human serum, EDTA, andheparinized plasma |
| AssayProtocol | competitive assay | immunometric assay |
| DetectionProtocol | electrochemiluminescenceimmunoassay | chemiluminescence assay |
| Traceability | Calibrated against NIBSC65/93 Standard | Calibrated against NIBSC65/93 Standard |
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Substantial equivalence differences
The following table compares the ELECSYS® Anti-Tg with the Predicate Device.
| Feature | New DeviceELECSYS Anti-Tg | Predicate DeviceImmulite 2000 Anti-TG Ab |
|---|---|---|
| Measuring range | 10 – 4000 IU/ml | 0 – 3000 IU/ml |
| Expected values | Up to 115 IU/ml (95thpercentile) | Nondetectable to 40 IU/ml(95th percentile) |
| Instrument | ELECSYS® 2010, 1010,and Modular Analytics E170Immunoassay Analyzers | Immulite 2000 Analyzer |
Substantial equivalence performance characteristics
The performance characteristics of the ELECSYS Anti-Tg and the Predicate Device are compared in the table below.
Reproducibility was determined using Elecsys reagents, pooled human sera and commercial controls according to a modified protocol (EP5-A) of the NCCLS: five or six times daily for 10 days (n = 59 or 60); intra-assay precision on E170, n = 21. The following results were obtained:
| Feature | New DeviceELECSYS Anti-Tg | Predicate DeviceImmulite 2000 Anti-TG Ab |
|---|---|---|
| Intra-assayprecision (%CV) | Human Serum• 4.9% at 62.8 IU/ml• 5.1% at 115 IU/ml• 4.6% at 290 IU/ml• 5.6% at 2894 IU/mlControls• 5.5% at 99.5 IU/ml• 5.6% at 232 IU/ml | • 4.9% at 43 IU/ml• 3.2% at 92 IU/ml• 3.5% at 205 IU/ml• 4.0% at 324 IU/ml• 3.7% at 508 IU/ml• 3.9% at 736 IU/ml |
| Total precision(%CV) | Human Serum• 8.7% at 62.8 IU/ml• 7.2% at 115 IU/ml• 5.9% at 290 IU/ml• 6.3% at 2894 IU/mlControls• 7.2% at 99.5 IU/ml• 6.7% at 232 IU/ml | • 5.7% at 23 IU/ml• 4.6% at 63 IU/ml• 5.0% at 201 IU/ml• 5.8% at 381 IU/ml• 5.0% at 784 IU/ml• 5.7% at 1644 IU/ml |
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Substantial equivalence performance characteristics, continued
The performance characteristics of the ELECSYS anti-Tg and the Predicate Device are compared in the table below.
| Feature | New DeviceELECSYS Anti-Tg | Predicate DeviceImmulite 2000 Anti-TG Ab |
|---|---|---|
| Analyticalsensitivity | < 10 IU/ml | 2.2 IU/ml |
| Limitations | No interference from icterus up to 66 mg/dL No interference from hemolysis up to 1.69 g/dL No interference from lipemia up to 2000 mg/dL triglyceride No interference from biotin up to 60 ng/mL No interference from rheumatoid factor up to 300 U/mL | No significant effect from bilirubin. No significant effect from hemolysis. |
| On-boardstability | Elecsys® 2010 / E170: 6 weeks Elecsys® 1010: 6 weeks (stored alternately in refrigerator and analyzer at ambient temperature 20-25 C) Up to 20 hr. opened in total | N/A |
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Substantial equivalence performance characteristics, continued
The performance characteristics of the ELECSYS Anti-Tg and the Predicate Device are compared in the table below.
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| Feature | New Device | Predicate Device | |
|---|---|---|---|
| ELECSYS Anti-Tg | Immulite 2000 Anti-TG Ab | ||
| Calibration | ● | Elecsys® 2010 / E170: | Every 2 weeks |
| frequency | ● Once per reagent lot | ||
| ● after one month (usingthe same reagent lot) | |||
| ● after 7 days (using thesame reagent kit on theanalyzer) | |||
| ● Elecsys® 1010 | |||
| ● With every reagent kit | |||
| ● after 7 days (using thesame reagent kit,ambient temperature 20- 25°C) | |||
| ● after 3 days (using thesame reagent kit,ambient temperature 25- 32°C) | |||
| ● Controls out of range (bothsystems) |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and neck, formed by three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image. The text is in all caps and is evenly spaced around the circle.
Food and Drug. Administration 2098 Gaither Road Rockville MD 20850 ·
Ms. Sherri L. Coenen Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
AUG 0 5 2002
Re: K020672
Trade/Device Name: ELECSYS® Anti-Tg Assay Regulation Number: 21 CFR § 866.5870 Regulation Name: Thyroid Autoantibody Immunological Test System Regulatory Class: II Product Code: JZO Dated: May 9, 2002 Received: May 13, 2002
Dear Ms. Coenen:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
: 上
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): N/A KO 20 6 7 2
Device Name: ELECSYS® Anti-Tg Test System
Indications For Use:
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 disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V V ---------------------------------------------------------------------------------------------------------------------------------------------------------OR Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-
: 本
તેર)
JP Rubio for G. Attain
V
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020672
§ 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).