The Elecsys® Anti-TPO CalSet is a lyophilized product consisting of sheep anti-TPO antibodies in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

AI/ML Overview

The Elecsys® Anti-TPO CalSet is a calibrator for the Elecsys Anti-TPO assay. The submission (K103171) is for a modified version of the CalSet, changing it from a liquid to a lyophilized (freeze-dried) material. The primary aim of the study is to demonstrate that the performance of the lyophilized Elecsys® Anti-TPO CalSet (candidate device) is substantially equivalent to the previously cleared liquid Elecsys® Anti-TPO CalSet (predicate device, K051890).

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Implicit: Substantial Equivalence to Predicate)	Reported Device Performance (Candidate Device)
Value Assignment	Must demonstrate comparable and accurate value assignment to the predicate.	Evaluated for value assignment. (Specific data not provided in summary, but conclusion states substantial equivalence).
Stability	Must maintain stability (unopened, reconstituted, and on-analyzer) comparable to or improved from the predicate.	Unopened: Store at 2-8°C until expiration date. Reconstituted: • At 2-8°C: 7 days • At -20°C: 8 weeks (freeze only once) • On analyzers at 20-25°C: use only once
Reconstitution	Must be reliably reconstitutable according to instructions.	Evaluated for reconstitution. (Specific data not provided in summary, but conclusion states substantial equivalence).
Intended Use	Must retain the same intended use: calibrating the quantitative Elecsys Anti-TPO assay.	Elecsys Anti-TPO CalSet is used for calibrating the quantitative Elecsys Anti-TPO assay on the Elecsys and cobas e immunoassay analyzers. (Same as predicate's CalSet function).
Analyte	Anti-TPO Antibodies (Sheep) (Same as predicate).	Anti-TPO Antibodies (Sheep) (Same).
Traceability	NIBSC 66/387 International Standard (Same as predicate).	NIBSC 66/387 International Standard (Same).
Matrix	Human serum (Same as predicate).	Human serum (Same).
Levels and Corresponding Concentrations	Two levels: Calibrator 1 (approx. 35.0 IU/mL) and Calibrator 2 (approx. 350 IU/mL) (Same as predicate).	Two levels: Calibrator 1 (approx. 35.0 IU/mL) and Calibrator 2 (approx. 350 IU/mL) (Same).
Overall Performance	Performance of the candidate device must be substantially equivalent to the predicate device.	The data demonstrate that the performance of the Elecsys® Anti-TPO CalSet is substantially equivalent to that of the predicate device.

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

The document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective).
The study is a comparison of a modified calibrator to a predicate calibrator. In such studies, the "test set" would typically refer to the samples used to evaluate the performance characteristics like value assignment and stability. While general areas of evaluation (value assignment, stability, reconstitution) are mentioned, specific sample sizes (e.g., number of batches, number of stability time points tested, number of assays run) are not detailed in this summary.

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

This information is not applicable in the context of this 510(k) summary. The ground truth for a calibrator's performance is established through analytical validation studies (e.g., measuring known concentrations, assessing stability over time with reference materials), not through expert interpretation of clinical cases. The "ground truth" for the calibrator's assigned values would be its traceable reference standard (NIBSC 66/387 International Standard).

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human interpretation of medical images or patient data requires consensus from multiple experts. This is an analytical device submission for a calibrator, where performance is measured objectively against analytical standards and specifications.

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 information is not applicable. This is not a diagnostic device that relies on human interpretation of images or data, nor does it involve AI assistance. It is a calibrator for an immunoassay.

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

This information is not applicable. This is an analytical calibrator, not a software algorithm or AI device. Its "performance" is its ability to accurately calibrate an immunoassay.

7. The type of ground truth used:

The ground truth for the assigned values of the calibrator is the NIBSC (National Institute for Biological Standards and Controls) 66/387 International Standard. This standard provides a reference point for the concentration of Anti-TPO antibodies.

8. The sample size for the training set:

This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a calibrator for a laboratory assay, not a machine learning or AI-based product.

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

This information is not applicable as there is no "training set" for this type of device.

Summary

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Elecsys® Anti-TPO CalSet 510(k) Summary ורו30/ 1 FEB 11 1 1 1

510(k) Summary	FEB 11 2011 K103171
Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence.
Submittername, address,contact	Roche Diagnostics9115 Hague Road, P.O. Box 50416Indianapolis, IN 46250-0416Contact Person: Sarah BaumannPhone: 317-521-3952Fax: 317-521-2324Email: sarah.baumann@roche.comSecondary Contact: Stephanie GreemanPhone: 317-521-2458Email: stephanie.greeman@roche.comDate Prepared: October 26, 2010
Device name	Proprietary name: Elecsys® Anti-TPO CalSetCommon name: Anti-TPO CalSetClassification name: Calibrator, Secondary
Predicatedevice	The Elecsys® Anti-TPO CalSet is substantially equivalent to other products incommercial distribution intended for similar use. We claim equivalency to thecurrently marketed Elecsys® Anti-TPO CalSet (cleared as part of the Elecsys®Anti-TPO test system on K051890).
Devicedescription	The Elecsys® Anti-TPO CalSet is a lyophilized product consisting of sheepanti-TPO antibodies in a human serum matrix. During manufacture, theanalyte is spiked into the matrix at the desired concentration levels.
Intended use	Elecsys Anti-TPO CalSet is used for calibrating the quantitative ElecsysAnti-TPO assay on the Elecsys and cobas e immunoassay analyzers.
Reason forsubmission	The Elecsys® Anti-TPO CalSet is being changed from a liquid to lyophilizedmaterial. The formulation of the candidate device (Elecsys® Anti-TPOCalSet, lyophilized) is identical to that of the predicate device, Elecsys®Anti-TPO CalSet (liquid, and cleared as part of the Elecsys® Anti-TPO testsystem on K051890).

Continued on next page

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510(k) Summary. Continued

The Elecsys® Anti-TPO CalSet is currently sold to customers as part of the Comparison table Elecsys® Anti-TPO assay kit. Upon clearance of the modified Elecsys® Anti-TPO CalSet device, it will be packaged and sold separately from the Elecsys® Anti-TPO assay kit.

Table 1 below compares Elecsys® Anti-TPO CalSet (K103171) with the predicate device, Elecsys® Anti-TPO CalSet (cleared as part of the Elecsys® Anti-TPO Test System on K051890).

Characteristic	Elecsys® Anti-TPO CalSet(Candidate Device, K103171)	Elecsys® Anti-TPO CalSet(K051890)
Intended Use	Elecsys Anti-TPO CalSet is used forcalibrating the quantitative ElecsysAnti-TPO assay on the Elecsys andcobas e immunoassay analyzers.	The Elecsys Anti-TPO immunoassay is for the invitro quantitative determination of antibodies tothyroid peroxidase in human serum and plasma. Theanti-TPO determination is used as an aid in thediagnosis of autoimmune thyroid diseases.
		The electrochemiluminescence assay "ECLIA" isintended for use on the Roche Elecsys 1010/2010and MODULAR ANALYTICS E170 (Elecsysmodule) immunoassay analyzers.1
Material Form(Format)	Lyophilized	Liquid
Analyte	Anti-TPO Antibodies (Sheep)	Same
Traceability	NIBSC (National Institute forBiological Standards and Controls)66/387 International Standard	Same
Matrix	Human serum	Same
Levels andCorrespondingConcentrations	TwoCalibrator 1: approx. 35.0 IU/mLCalibrator 2: approx. 350 IU/mL	TwoCalibrator 1: approx. 35.0 IU/mLCalibrator 2: approx. 350 IU/mL
Stability	Unopened:• Store at 2-8°C until expiration dateReconstituted:• at 2-8°C: 7 days• at -20 °C: 8 weeks (freeze only once)• on the analyzers at 20-25 °C: useonly once	Unopened:• Store at 2-8°C until expiration dateOpened:• at 2-8°C: 6 weeks• at 20-25 °C on Elecsys 1010/2010: up to 5 hours• MODULAR ANALYTICS E170: use only once

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1 The Elecsys® Anti-TPO CalSet was originally cleared as part of the Elecsys® Anti-TPO test system on K051890 and is currently sold to customers as part of the Elecsys Anti-TPO assay kit. As such, the Intended Use of the assay reagent kit is listed in Table 1. Upon clearance of the modified Elecsys® Anti-TPO CalSet device, it will be packaged and sold separately from the assay kit.

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510(k) Summary, Continued

The Elecsys® Anti-TPO CalSet is currently sold to customers as part of the Comparison table, continued Elecsys® Anti-TPO assay kit. Upon clearance of the modified Elecsys® Anti-TPO CalSet device, it will be packaged and sold separately from the Elecsys® Anti-TPO assay kit. Table 1 below compares Elecsys® Anti-TPO CalSet (K103171) with the predicate device, Elecsys® Anti-TPO CalSet (cleared as part of the Elecsys®

Anti-TPO Test System on K051890).

Characteristic	Elecsys® Anti-TPO CalSet(Candidate Device, K103171)	Elecsys® Anti-TPO CalSet(K051890)
Handling	Dissolve carefully the contents of onebottle by adding exactly 1.5 mL ofdistilled or deionized water and allowto stand closed for 15 minutes toreconstitute. Mix carefully, avoidingthe formation of foam. Transfer thereconstituted calibrator into the emptylabeled snap-cap bottles supplied.	The reagents in the kit are ready for use andsupplied in the bottles compatible with the system.Elecsys 1010/2010 analyzers: The Elecsyscalibrators Cal1 and Cal2 and the Elecsys controls²PC A-TPO1 and PC A-TPO2 should only be lefton the analyzers at 20-25°C duringcalibration/quality control. After use, close thebottles as soon as possible and store at 2-8°C.
	Elecsys 2010 and cobas e 411analyzers: The calibrators should onlybe left on the analyzers duringcalibration at 20-25°C. Perform onlyone calibration procedure per aliquot.If necessary, freeze in aliquots; seesection on MODULAR ANALYTICSE170 and cobas e 601 analyzers.	Ensure that no calibration and control solution istrapped in the opened snap-cap. Because ofpossible evaporation effects, not more than 5calibration/quality control procedures per bottle setshould be performed.
	MODULAR ANALYTICS E170 andcobas e 601 analyzers: Unless theentire volume is necessary forcalibration on the analyzer, transferaliquots of the reconstituted calibratorinto empty snap-cap bottles (CalSetVials). Attach the supplied labels tothese additional bottles. Store thealiquots for later use at -20°C. Performonly one calibration procedure peraliquot.	MODULAR ANALYTICS E170 analyzer: Unlessthe entire volume is necessary for calibration andquality control on the analyzer, transfer aliquots ofthe ready-for-use calibrators and controls intoempty snap-cap bottles (CalSet Vials/ControlSetVials). Attach the supplied labels to theseadditional bottles. Store the aliquots for later use at2-8°C. Perform only one calibration or controlprocedure per aliquot.
		All information required for correct operation isread in via the respective reagent barcodes.

Table 1. Comparison of Candidate and Predicate Devices, continued

Continued on next page

2 The control materials originally sold with the Elecsys® Anti-TPO test system (PC A-TPO1 and PC A-TPO2) are no longer included in the assay kit. A new control material, Elecsys® PreciControl ThyroAB, was cleared on K092320 and includes the appropriate levels of anti-TPO for quality control of the Elecsys® Anti-TPO assay.

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510(k) Summary, Continued

Performancecharacteristics	The Elecsys® Anti-TPO CalSet was evaluated for value assignment, stability, and reconstitution.
Conclusion	The data demonstrate that the performance of the Elecsys® Anti-TPO CalSet is substantially equivalent to that of the predicate device, Elecsys® Anti-TPO CalSet (cleared as part of the Elecsys® Anti-TPO Test System on K051890).

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of a bird in flight, with its wings spread. The bird is composed of three curved lines, and it appears to be soaring upwards.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

FEB 1 1 201

Roche Diagnostics c/o Ms. Sarah Baumann Regulatory Affairs Consultant 9115 Hague Road Indianapolis. IN 46250-0416

Re: K103171

Trade/Device Name: Elecsys® Anti-TPO CalSet Regulation Number: 21 CFR 8862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIX Dated: January 06, 2011 Received: January 07, 2011

Dear Ms. Baumann:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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

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Page 2 - Ms. Sarah Baumann

CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ia m Clark

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K/ 0 3/7/

Device Name: Elecsys Anti-TPO CalSet

Indications for Use: Elecsys Anti-TPO CalSet is used for calibrating the quantitative Elecsys Anti-TPO assay on the Elecsys and cobas e immunoassay analyzers.

Prescription Use Over-The-Counter Use × Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

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

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

Geena Philip

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) /0.3/7/

Page 1 of.

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.