The Elecsys Anti-TPO immunoassay is for the in vitro quantitative determination of antibodies to thyroid peroxidase in human serum and plasma. The anti-TPO determination is used as an aid in the diagnosis of autoimmune thyroid diseases.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

Device Description

The COBAS Elecsys® Anti-TPO Test System is based on a competitive immunoassay with streptavidin microparticles and electrochemiluminescence detection. First and second incubations are nine minutes in duration. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode, unbound substances are removed. Voltage is applied to the electrode inducing chemiluminescent emission which is measured by a photomultiplier. 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.

AI/ML Overview

This K051890 submission for the COBAS Elecsys® anti-TPO device is a modification of an existing device (K000155). The acceptance criteria and supporting evidence are presented for the modified device by showing its equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating that the modified device performs "Same" as the predicate device (K000155) across several key technical specifications and performance characteristics. The primary change highlighted is related to Biotin Interference, where the predicate allowed up to 60 ng/ml and the modified device has an acceptance criteria of up to 10 ng/ml. This suggests an improvement or a more stringent and defined limit for the modified device.

Acceptance Criteria Category	Predicate Device (K000155) Performance	COBAS Elecsys® Anti-TPO (Modified Device) Performance	Met Acceptance Criteria?
Intended Use	for the quantitative determination of antibodies to thyroid peroxidase in human serum and plasma.	Same	Yes
Indication for Use	as an aid in the diagnosis of autoimmune thyroid diseases	Same	Yes
Sample Type	human serum and plasma	Same	Yes
Dilution Performance	Autoantibodies are heterogeneous and this may lead to non-linear dilution phenomena for certain individual samples.	Same	Yes
Traceability / Standardization	WHO 66/387	Same	Yes
Test Principle	Competitive chemiluminescence	Same	Yes
Measuring Range	5 - 600 IU/ml	Same	Yes
Reagent Stability (Unopened)	at 2-8°C up to the expiration date.	Same	Yes
Reagent Stability (Opened, 2-8°C)	up to six weeks.	Same	Yes
Reagent Stability (Opened, on E170 / 2010)	two weeks	Same	Yes
Reagent Stability (Opened, on 1010)	one week (store alternately in refrigerator and on analyzer - at ambient temperature 20-25 °C; up to 20 hours in total).	Same	Yes
Interference - Bilirubin	up to 66 mg/dl	Same	Yes
Interference - Hemolysis	up to 1.5 g/dl	Same	Yes
Interference - Lipemia	up to 2100 mg/dl	Same	Yes
Interference - Biotin	up to 60 ng/ml	up to 10 ng/ml	Yes (More stringent/defined)
Interference - Rheumatoid factors	up to 1500 U/ml	Same	Yes

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating equivalence to a predicate device, assuming the predicate's performance claims, which would have been supported by its own testing data during its original clearance. The listed "Limitations" for interference are typically derived from dedicated interference studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For in vitro diagnostic devices like this immunoassay, "ground truth" often refers to the clinical diagnosis or a well-established reference method. The document implicitly uses the predicate device as the comparison for "ground truth" in terms of performance characteristics.

4. Adjudication method for the test set

This information is not provided. Given the nature of an immunoassay, the "adjudication method" would likely involve comparing results to a reference method or clinical diagnoses, rather than human expert agreement on interpretation.

5. 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

This is an immunoassay device, not an AI-assisted diagnostic imaging or interpretation device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone immunoassay system (algorithm/device only). Its performance is evaluated intrinsically through various analytical studies (e.g., precision, measuring range, interference) to ensure it meets performance specifications, and in this case, demonstrates equivalence to a predicate device. The document implies these standalone performances were assessed to confirm the "Same" claims.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the purpose of this 510(k) submission, the "ground truth" is largely implied to be the established performance characteristics and validation of the predicate device (Elecsys Anti-TPO, K000155). The submission is based on demonstrating substantial equivalence to this legally marketed device across all critical performance parameters. For inherent analytical validation, the "ground truth" for parameters like accuracy and precision would typically rely on reference methods, spiked samples, and internal controls. For clinical utility, the "aid in the diagnosis of autoimmune thyroid diseases" would be linked to clinical diagnoses validated by other means (e.g., patient history, other diagnostic tests).

8. The sample size for the training set

This information is not provided. Immunoassay development typically involves extensive characterization and optimization, but the concept of a "training set" in the machine learning sense is not directly applicable to a traditional immunoassay. The development and optimization data would serve a similar purpose.

9. How the ground truth for the training set was established

As with the previous point, the concept of a "training set" with a defined "ground truth" in the AI/ML context doesn't directly apply here. Instead, during the development of an immunoassay, the "ground truth" for various analytical studies (e.g., sensitivity, specificity, linearity, interference) would be established using:

Reference materials/standards: For quantitative measurements and calibration.
Known positive and negative samples: For initial analytical performance characterization.
Clinical samples with established diagnoses: To assess clinical performance and aid in setting cut-off values.

The submission focuses on demonstrating that the modified device performs identically to the predicate device across critical parameters, with a specified change in biotin interference tolerance.

Summary

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K051890

AUG 4 - 2005

510(k) Summary - COBAS Elecsys® anti-TPO

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 Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-3544
	Contact person: Kay A. Taylor
	Date prepared: July 11, 2005
Device Name	Proprietary name: Roche Diagnostics COBAS Elecsys® Anti-TPO
	Common name: anti-TPO Assay
	Classification name: System, Test, Thyroid Autoantibody
Device description	The COBAS Elecsys® Anti-TPO Test System is based on a competitive immunoassay with streptavidin microparticles and electrochemiluminescence detection. First and second incubations are nine minutes in duration. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode, unbound substances are removed. Voltage is applied to the electrode inducing chemiluminescent emission which is measured by a photomultiplier. 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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510(k) Summary - COBAS Elecsys® anti-TPO, continued

Intended use	Immunoassay for the in vitro quantitative determination of antibodies tothyroid peroxidase in human serum and plasma. The anti-TPO determinationis used as an aid in the diagnosis of autoimmune thyroid diseases. Theelectrochemiluminescence immunoassay "ECLIA" is intended for use on theRoche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsysmodule) immunoassay analyzers.
PredicateDevice	The COBAS Elecsys® Anti-TPO Test System is equivalent to other deviceslegally marketed in the United States. We claim equivalence to the ElecsysAnti-TPO (K000155).
DeviceComparison	The table below illustrates the similarities between the Elecsys Anti-TPO(K000155) and the COBAS Elecsys Anti-TPO (modified device).

Topic	Elecsys® Anti-TPO(K000155)	COBAS Elecsys® Anti-TPO(Modified Device)
Intended use	for the quantitative determination ofantibodies to thyroid peroxidase inhuman serum and plasma.	same
Indication foruse	as an aid in the diagnosis ofautoimmune thyroid diseases	same
Sample type	human serum and plasma	same
Dilutionperformance	Autoantibodies are heterogenous andthis may lead to non-linear dilutionphenomena for certain individualsamples.	same
Traceability /Standardization	WHO 66/387	same
Test Principle	Competitive chemiluminescence	same

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510(k) Summary - COBAS Elecsys® anti-TPO, continued

Topic	Elecsys® Anti-TPO(K000155)	COBAS Elecsys® Anti-TPO(Modified Device)
Measuringrange	5 - 600 IU/ml	Same
ReagentStability	Unopened:- at 2-8°C up to the expiration date.Opened:- at 2-8°C up to six weeks.- on E170 / 2010: two weeks- on 1010: one weeks storealternately in refrigerator and onanalyzer - at ambient temperature 20-25 °C; up to 20 hours in total).	Same
Limitations	No interference from;Bilirubin up to 66 mg/dl	Same
Limitations	Hemolysis up to 1.5 g/dl	Same
Limitations	Lipemia up to 2100 mg/dl	Same
Limitations	Biotin up to 60 ng/ml	Biotin up to 10 ng/ml
Limitations	Rheumatoid factors up to 1500 U/ml	Same

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Public Health Service

Image /page/3/Picture/2 description: The image shows a logo for the Department of Health & Human Services (USA). The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the caduceus symbol.

Roche Diagnostics Corp. c/o Ms Kay A Taylor Regulatory Affairs Principal Centralized Diagnostics 9115 Hague Rd. Indianapolis, IN 46250

AUG 4 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: K051890

Trade/Device Name: Roche Diagnostics Cobas Elecsys® anti-TPO Test System Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid antibody Immunological Test System Regulatory Class: Class II Product Code: JZO Dated: July 11, 2005 Received: July 12, 2005

Dear Ms. Taylor:

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 -

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely yours,

bert Beckerh

Robert L. Becker, Jr., MD, PJ Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K051890

Device Name: cobas Elecsys Anti-TPO

Indications For Use:

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

Prescription Use XXXXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Maria M Clan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

510(k) K051890

Regulation Number and Section

§ 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).