Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg autoantibodies determination is used as an aid in the detection of autoimmune thyroid diseases in conjunction with other laboratory and clinical findings.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzer.

Device Description

The Elecsys Anti-Tg immunoassay makes use of a competitive test principle using biotinylated human antigen and monoclonal human anti-Tg antibodies labeled with a ruthenium complex. The Elecsys Anti-Tg immunoassay is intended for the quantitative determination of antibodies to thyroglobulin in human serum and plasma. 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.

AI/ML Overview

The provided text describes the performance evaluation of the Elecsys Anti-Tg immunoassay, a diagnostic device, and its acceptance criteria. Here's a breakdown of the requested information based on the text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a single table labeled "Acceptance Criteria" with corresponding "Reported Device Performance" in a direct side-by-side format. Instead, it describes various performance evaluations and states whether "All predefined acceptance criteria was met" for each. However, we can reconstruct a table based on the provided details for the non-clinical performance evaluation.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Precision	All predefined acceptance criteria met (specific numerical criteria not detailed in this section for repeatability/intermediate precision and lot-to-lot reproducibility)	Repeatability (within-run precision) and Intermediate Precision (within-laboratory precision) measured according to CLSI guideline EP05-A3. Accepted for all samples. Lot-to-lot Reproducibility measured according to CLSI guideline EP05-A3 using three reagent lots. Accepted.
Analytical Sensitivity
Limit of Blank (LoB)	LoB claim in labeling set to 9 IU/mL (implied acceptance)	Determined according to CLSI EP17-A2. LoB claim in labeling will be set to 9 IU/mL.
Limit of Detection (LoD)	LoD claim in labeling set to 10 IU/mL (implied acceptance)	Determined according to CLSI EP17-A2. LoD claim in labeling will be set to 10 IU/mL.
Limit of Quantitation (LoQ)	LoQ claim in labeling set to 15 IU/mL (implied acceptance)	Determined according to CLSI EP17-A2. LoQ claim in labeling will be set to 15 IU/mL.
Linearity	Confirmed to support the measuring range of 15 - 4000 IU/mL (implied acceptance)	Assessed according to CLSI EP06-Ed2, study design B, using weighted linear regression analysis. Linearity confirmed to support measuring range of 15 - 4000 IU/mL.
Endogenous Interferences	All predefined acceptance criteria met (specific numerical criteria not detailed)	Evaluated for Biotin, Lipemia, Hemoglobin, Bilirubin, Rheumatoid Factor, Tg. All predefined acceptance criteria met. Proposed labeling claims: Biotin ≤ 1200 ng/mL, Lipemia ≤ 2000 mg/dL, Hemoglobin ≤ 600 mg/dL (for conc. ≤ 115 IU/mL), Bilirubin ≤ 66 mg/dL, Rheumatoid Factor ≤ 300 IU/mL, Tg ≤ 100 ng/mL.
Analytical Specificity/Cross-Reactivity	No cross-reaction with Anti-TPO detected (implied acceptance)	Cross-reactivity study conducted with anti-TPO. No cross-reaction with Anti-TPO detected.
Exogenous Interferences	All predefined acceptance criteria met for all drugs tested (implied acceptance)	Evaluated 17 commonly and 14 specially used pharmaceutical compounds. All predefined acceptance criteria met, and no interference observed.
Sample Matrix Comparison	Results within specification and support use of specified matrices (implied acceptance)	Compared values from serum, K2-EDTA, and K3-EDTA plasma. Results were within specification and support the use of Serum (standard or separating gel), K2-EDTA, and K3-EDTA plasma.
Method Comparison to Predicate	Not explicitly stated as pass/fail; presented as regression results	Compared to predicate device (K053426) using 129 human serum samples. Linear Regression: y = 0.905x + 48.0, r = 0.990 Passing Bablok: y = 0.974x + 1.72, τ = 0.930
Reagent Stability
Reagent On-board Stability	42 days (6 weeks) on-board (implied acceptance)	Tested on one cobas e 411 analyzer. Stable for up to 42 days (6 weeks).
Reagent Stability After First Opening	42 days (6 weeks) after first opening (implied acceptance)	Tested on one cobas e 411 analyzer. Stable for up to 42 days (6 weeks) when stored at 2-8°C.
Calibration Stability
Lot Calibration Stability	Calibration every 28 days (1 month) (implied acceptance)	Tested on one cobas e 411 analyzer. Recommended calibration frequency of every 28 days (1 month).
On-board Calibration Stability	7 days without new calibration (implied acceptance)	Tested on one cobas e 411 analyzer. Stable for up to 7 days without a new calibration.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Sizes:
- Precision: Not explicitly stated, but includes "Human serum 1-5" and "PC THYRO1-2" (presumably replicates for each, as per CLSI EP05-A3 which requires sufficient replicates).
- Lot-to-lot Reproducibility: "three reagent lots" (number of samples per lot not specified).
- Analytical Sensitivity (LoB, LoD, LoQ): Not explicitly stated, determined according to CLSI EP17-A2 which has sample size recommendations.
- Linearity: "Six dilution series" using "native human serum samples and sample pools" (number of samples/pools not specified).
- Endogenous Interferences: Not explicitly stated per substance, but mentions "Six endogenous substances."
- Analytical Specificity/Cross-Reactivity: Not explicitly stated (for anti-TPO).
- Exogenous Interferences: "17 commonly and 14 specially used pharmaceutical compounds" (number of samples not stated).
- Sample Matrix Comparison: "blood from 13 donors" (tested across serum, K2-EDTA, K3-EDTA plasma, and serum separation tubes from 3 manufacturers).
- Method Comparison to Predicate: "total of 129 human serum samples."
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It is a "510(k) Summary" for an FDA submission, reporting on laboratory performance studies. Given they are "non-clinical performance evaluation," these are typically controlled laboratory studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is an in-vitro diagnostic (IVD) immunoassay. The ground truth for such devices is established through analytical testing against reference materials, established methods, and clinical samples with known characteristics, not typically by expert consensus in the same way as an imaging AI. The "ground truth" here is the precise concentration or presence/absence of the analyte (thyroglobulin antibodies) as determined by the study's reference method or expected values for standards/controls.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of IVD analytical performance study. Adjudication methods like 2+1 or 3+1 are common in clinical trials or imaging studies where expert readers interpret results, but not for direct quantitative measurements from an immunoassay. The acceptance criteria are based on statistical analysis of quantitative results (e.g., precision, linearity, recovery, regression).

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

Not applicable. This is an immunoassay for determining antibody levels, not an imaging device or an AI intended to assist human readers. Hence, no MRMC study was performed, and human reader improvement with AI assistance is not relevant to this device's evaluation.

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

This entire non-clinical performance evaluation section (4. NON-CLINICAL PERFORMANCE EVALUATION) describes the standalone performance of the Elecsys Anti-Tg immunoassay (a device, not an AI algorithm). The measurements are performed by the "cobas e 411 immunoassay analyzer," which acts as the "algorithm" or automated system. There's no human "in the loop" for the direct measurement results themselves, though human operators are involved in running the tests and interpreting the results in a clinical setting.

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

The ground truth for the analytical performance studies (precision, linearity, sensitivity, interferences, stability) is based on:

CLSI guidelines: The studies adhere to specific Clinical and Laboratory Standards Institute (CLSI) guidelines (e.g., EP05-A3, EP17-A2, EP06-Ed2), which define how such analytical characteristics are determined using reference materials, spiked samples, and statistical methods.
Reference Standards/Materials: Implied in sections like "Traceability/Standardization" against the NIBSC 65/93 Standard, and the use of calibrators (Anti-Tg CalSet) and controls (PreciControl ThyroAB).
Known Sample Characteristics: For linearity, samples with varying known concentrations are typically used. For interference studies, samples spiked with known interferents are used.
Predicate Device Comparison: For method comparison, the predicate device's results serve as a comparative reference.

8. The sample size for the training set

Not applicable in the context of an immunoassay. This device is an in-vitro diagnostic test kit (reagents) used on an existing analyzer. It does not involve a "training set" in the machine learning sense. The "development" or "training" of such a diagnostic involves optimizing the chemical and biological components of the assay (reagents, antibodies, detection method) and calibrating the system across a range of known concentrations.

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

As there is no "training set" in the AI/machine learning sense, this question is not applicable. The development process for an immunoassay involves extensive research and development to create reagents that accurately quantify the target analyte. Calibration is done using reference materials with assigned values, and the assay's performance characteristics (as detailed in section 4) are then rigorously validated.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.

September 15, 2023

Roche Diagnostics Phil Williams Regulatory Affairs Consultant 9115 Hague Road Indianapolis, Indiana 46250

Re: K222610

Trade/Device Name: Elecsys Anti-Tg Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid Autoantibody Immunological Test System Regulatory Class: Class II Product Code: JZO Dated: Mav 19, 2023 Received: May 19, 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

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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) K222610

Device Name Elecsys Anti-Tg

Indications for Use (Describe)

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzer.

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-Tg

510(k) Summary

Submitter Name	Roche Diagnostics
Address	9115 Hague RoadP.O. Box 50416Indianapolis, IN 46250-0457
Contact	Phil WilliamsPhone: 317-209-5478Email: phil.williams@roche.com
Date Prepared	August 25, 2022
Proprietary Name	Elecsys Anti-Tg
Common Name	Thyroid autoantibody immunological test system
Classification Name	System, Test, Thyroid Autoantibody
Product Codes,Regulation Numbers	JZO, 21 CFR 866.5870
Predicate Devices	Roche Diagnostics Elecsys Anti-Tg (K053426)
Establishment Registration	Roche Diagnostics GmbH Mannheim, Germany: 9610126Roche Diagnostics GmBH Penzberg, Germany: 9610529Roche Diagnostics Indianapolis, IN United States: 1823260.

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1. DEVICE DESCRIPTION

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.

1.1. Reagents

The reagent working solutions include:

Rack Pack (kit placed on the analyzer)

M: Streptavidin-coated microparticles .
R1: Tg~biotin .
R2: Anti Tg-Ab~Ru(bpy) .

INDICATIONS FOR USE 2.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzer.

3. TECHNOLOGICAL CHARACTERISTICS

The following table compares the Elecsys Anti-Tg with its predicate device, Roche Elecsys Anti-Tg (K053426).

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Feature	Candidate DeviceElecsys Anti-Tg	Predicate DeviceRoche Elecsys Anti-Tg (K053426)
Intended Use	Immunoassay for the in vitroquantitative determination ofantibodies to thyroglobulin inhuman serum and plasma. Theanti-Tg autoantibodiesdetermination is used as an aid inthe detection of autoimmunethyroid diseases in conjunctionwith other laboratory and clinicalfindings.The electrochemiluminescenceimmunoassay "ECLIA" isintended for use on cobas e 411immunoassay analyzer.	Immunoassay for the in vitroquantitative determination ofantibodies to thyroglobulin in humanserum and plasma. The anti-Tgdetermination is used as an aid in thedetection of autoimmune thyroiddiseases.The electrochemiluminescenceimmunoassay "ECLIA" is intendedfor use on Elecsys and cobas eimmunoassay analyzers.
Assay Method	Competitive	Same
Test type	Quantitative	Same
Detection Method	Electrochemiluminescence"ECLIA"	Same
Application Time	18 minute	Same
Assay protocol	Sample + R1, 1st incubationR2 + Beads, 2nd incubation	Same
Handling of R1 and R2	Liquid, ready to use	Same
Sample Type/Matrix	Human serum, plasma	Same
Sample Anticoagulants	K2/K3-EDTA	Sodium heparin, K2/K3-EDTA
Pipetting volume sample	10 μL	Same
Calibrator	Anti-Tg CalSet	Included in Test Kit as Anti-Tgcalibrator 1 and Anti-Tg calibrator 2
Calibration Method	2-point calibration	Same

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Feature	Candidate DeviceElecsys Anti-Tg	Predicate DeviceRoche Elecsys Anti-Tg (K053426)
Calibration Interval	Calibration must be performedonce per reagent lot using freshreagent (i.e. not more than 24hours since the reagent kit wasregistered on the analyzer).Calibration interval may beextended based on acceptableverification of calibration by thelaboratory.Renewed calibration isrecommended as follows:• after 1 month (28 days) whenusing the same reagent lot• after 7 days (when using thesame reagent kit on the analyzer)• as required: e.g. quality controlfindings outside the defined limits	Calibration must be performed onceper reagent lot using fresh reagent (i.e.not more than 24 hours since thereagent kit was registered on theanalyzer).Renewed calibration is recommendedas follows:• after 1 month (28 days) when usingthe same reagent lot• after 7 days (when using the samereagent kit on the analyzer)• as required: e.g. quality controlfindings outside the defined limits
Controls	PreciControl ThyroAB	Included in Test Kit as PreciControlAnti-Tg 1 and PreciControl Anti-Tg 2
Traceability/Standardization	Standardized against the NIBSC(National Institute for BiologicalStandards and Control) 65/93Standard	Same
Reagent Stability	• unopened at 2-8 °C: up to thestated expiration date• after opening at 2-8 °C: 6 weeks• on the analyzer: 6 weeks	Same
Measuring Range	15 - 4000 IU/mL	10 - 4000 IU/mL
Biotin Tolerance	< 1200 ng/mL	< 60 ng/mL

NON-CLINICAL PERFORMANCE EVALUATION 4.

The following performance data are provided in support of the substantial equivalence determination. All performance specifications were met.

Precision 4.1.

Repeatability and Intermediate Precision 4.1.1.

Precision measurements were conducted for the updated Elecsys Anti-Tg to evaluate repeatability (within-run precision) and the intermediate precision (within-laboratory precision)

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cobas e 411 analyzer
		Repeatability			Intermediate precision
Sample	Mean	SD	CV	SD	CV
	IU/mL	IU/mL	%	IU/mL	%
Human serum 1	15.7	1.32	8.4	2.28	14.5
Human serum 2	110	7.78	7.1	8.29	7.6
Human serum 3	1953	64.0	3.3	77.4	4.0
Human serum 4	2495	106	4.2	125	5.0
Human serum 5	3816	171	4.5	171	4.5
PCb) THYRO1	79.4	5.41	6.8	6.68	8.4
PC THYRO2	177	14.0	7.9	17.2	9.7

according the CLSI guideline EP05-A3. All predefined acceptance criteria was met for the precision experiments.

Lot-to-lot Reproducibility 4.1.2.

Precision measurements were conducted according to CLSI guideline EP05-A3 to evaluate Lotto-Lot Reproducibility using three reagent lots. All predefined acceptance criteria was met for the lot-to-lot reproducibility experiment.

4.2. Analytical Sensitivity

4.2.1. Limit of Blank (LoB)

The Limit of Blank (LoB) was determined according to CLSI EP17-A2. The LoB claim in the labeling will be set to 9 IU/mL.

Limit of Detection (LoD) 4.2.2.

The Limit of Detection (LoD) was determined according to CLSI EP17-A2. The LoD claim in the labeling will be set to 10 IU/mL.

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Limit of Quantitation (LoQ) 4.2.3.

The Limit of Quantitation (LoQ) was determined according to CLSI EP17-A2. The LoQ claim in the labeling will be set to 15 IU/mL.

4.3. Linearity

Linearity of the Elecsys Anti-Tg assay was assessed according to CLSI EP06-Ed2, study design B, using weighted linear regression analysis. Six dilution series, using native human serum samples and sample pools, were measured on the cobas e 411 analyzer to demonstrate that measurements across the claimed measuring range are linear. Linearity was confirmed to support the measuring range of 15 - 4000 IU/mL.

Endogenous Interferences 4.4.

Six endogenous substances were evaluated for potential interference with the Elecsys Anti-Tg assay on the cobas e 411 analyzer. All predefined acceptance criteria were met, and the proposed labeling claims for each endogenous substance can be found below:

Biotin ≤ 1200 ng/mL

Lipemia (Intralipid) ≤ 2000 mg/dL

Hemoglobin ≤ 600 mg/dL for sample concentrations ≤ 115 IU/mL

Bilirubin ≤ 66 mg/dL

Rheumatoid Factor ≤ 300 IU/mL

Tg ≤ 100 ng/mL

Analytical Specificity/Cross-Reactivity 4.5.

A cross-reactivity study was conducted with Elecsys Anti-Tg on the cobas e 411 analyzer to evaluate the potential cross-reactivity of the assay with anti-TPO. There was no cross-reaction with Anti-TPO detected.

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4.6. Exogenous Interferences

An exogenous interference study was conducted to evaluate 17 commonly and 14 specially used pharmaceutical compounds for potential interference with the Elecsys Anti-Tg assay on the cobas e 411 analyzer. The predefined acceptance criteria was met for all drugs tested, and no interference was observed.

Sample Matrix Comparison 4.7.

The effect on quantitation of analyte in the presence of anticoagulants with Anti-Tg was determined by comparing values obtained from native human serum samples and sample pools drawn into serum, K2-EDTA, and K3-EDTA plasma primary tubes. Serum separation tubes from 3 separate manufacturers and blood from 13 donors were measured in duplicate with one reagent lot and evaluated on the basis of recovery relative to the serum tube without separating gel. The results were within specification and support the use of Serum collected using standard serum tubes or tubes containing separating gel, K2-EDTA, and K3-EDTA plasma.

Method Comparison to Predicate 4.8.

A method comparison was performed using the Elecsys Anti-Tg updated assay and the Elecsys Anti-Tg current assay, using a total of 129 human serum samples. The sample concentrations were between 23.1 and 3609 IU/mL. The results can be found below:

Linear Regression y = 0.905x + 48.0 r = 0.990 Passing Bablok y = 0.974x + 1.72 τ = 0.930

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Reagent Stability 4.9.

Reagent On-board Stability 4.9.1.

On-board reagent stability for the Elecsys Anti-Tg assay was tested on one cobas e 411 analyzer. Elecsys Anti-Tg reagent kits can be stored on-board the analyzers for up to 42 days (6 weeks). A new calibration of the kit kept on-board is recommended every 7 days.

4.9.2. Reagent Stability After First Opening

Reagent stability after first opening for the Elecsys Anti-Tg assay was tested on one cobas e 411 analyzer. Elecsys Anti-Tg reagent kits can be used after first opening for up to 42 days (6 weeks) when stored at 2-8°C.

4.10. Calibration Stability

4.10.1. Lot Calibration Stability

Lot calibration frequency for the Elecsys Anti-Tg assay was tested on one cobas e 411 analyzer. Calibration of an Elecsys Anti-Tg reagent lot is recommended every 28 days (1 month). During that time period, fresh reagent kits of the same lot can be used without calibration using the calibration curve of the day 0 reagent kit.

4.10.2. On-board Calibration Stability

Reagent on-board calibration frequency for Elecsys Anti-Tg assay was tested on one cobas e 411 analyzer. Elecsys Anti-Tg reagent kits can be stored on board of the analyzers for up to 7 days without a new calibration.

EXTERNAL (CLINICAL) TESTING 5.

Not Applicable

6. CLINICAL PERFORMANCE EVALUATION

Not Applicable

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7. ADDITIONAL INFORMATION

The Elecsys Anti-Tg is intended to be used with the following calibrators and controls:

Anti-Tg CalSet .
PreciControl ThyroAB .

The Anti-Tg CalSet is regulated under product code JIS and 21 CFR 862.1150 and is exempt from Premarket notification and therefore, is not included with this submission.

The PreciControl ThyroAB is regulated under product code JJY and 21 CFR 862.1660 and is exempt from Premarket notification and therefore, is not included with this submission.

8. CONCLUSIONS

The information provided in this 510(k) Premarket Notification supports the determination that the Elecsys Anti-Tg immunoassay (updated assay, Mat. No. 09004998160) is substantially equivalent to the predicate device, Elecsys Anti-Tg system (current assay, Mat. No. 06368697190).

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).