ELECSYS TROPONIN T CALCHECK 5 by ROCHE DIAGNOSTICS CORP.

The Elecsys Troponin T CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Troponin T reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a quality control material, the Elecsys Troponin T CalCheck 5. This type of device does not involve studies with "device performance," "sample sizes for test sets," "experts for ground truth," "adjudication methods," or "MRMC comparative effectiveness studies" in the way these terms are typically used for diagnostic or AI-driven medical devices.

Instead, the "performance" of a quality control material refers to its ability to accurately verify the calibration and assay range of an in vitro diagnostic (IVD) test (in this case, the Elecsys Troponin T reagent on specific immunoassay analyzers).

Therefore, a direct answer to your request in the context of a diagnostic or AI device is not applicable for this document.

However, I can extract the relevant information about the acceptance criteria and how a device like this would meet them, based on the principles of regulatory clearance for IVD quality control products.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Typical for QC Material)
Intended Use Compatibility: The QC material must be compatible with the specified Elecsys Troponin T reagent and Elecsys/cobas e immunoassay analyzers for calibration verification and assay range verification.	The device's "Indications for Use" statement confirms its intended use with `Elecsys Troponin T reagent on the indicated Elecsys and cobas e immunoassay analyzers.` This explicitly defines the compatibility.
Traceability: The assigned values for the control material levels must be traceable to a recognized reference method or material.	Not explicitly stated in the provided document, but for such a device, the manufacturer would provide data demonstrating traceability of the assigned Troponin T values to an accepted reference standard (e.g., higher-order reference methods or materials).
Stability: The QC material must maintain its assigned values and integrity over its stated shelf-life and in-use period.	Not explicitly stated in the provided document, but the manufacturer's submission would include stability studies (real-time and accelerated) demonstrating that the material remains within acceptable limits for its claimed shelf-life and after reconstitution/opening.
Homogeneity: Different aliquots of the control material must yield consistent results.	Not explicitly stated in the provided document, but manufacturing data would show consistent composition across production lots.
Value Assignment: The assigned values for each control level must be established accurately and precisely through a robust value assignment protocol.	Not explicitly stated in the provided document, but the manufacturer's submission would detail the process and data for assigning the target values and their acceptable ranges for each level of the CalCheck 5. This would involve multiple measurements on multiple instruments using reference methods.

Regarding the Study for Acceptance Criteria:

The "study" for a quality control material like Elecsys Troponin T CalCheck 5 is typically a verification and validation (V&V) program conducted by the manufacturer. This program encompasses various tests and analyses rather than a single clinical trial with patient data or expert reads.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not applicable in the sense of patient samples. For a QC material, the "test set" would be the number of vials/lots of the QC material tested and the number of measurements taken to establish its characteristics (e.g., homogeneity, stability, value assignment). This is typically determined by statistical sampling plans to ensure representativeness and sufficient power for the specific tests. The provenance would be the manufacturer's internal laboratories.
Data Provenance: The data would originate from prospective internal laboratory studies conducted by Roche Diagnostics during the product development and manufacturing process. This would typically be conducted at their facilities in a controlled environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. For a quality control material, "ground truth" for its characteristics (assigned values, stability) is established through rigorous analytical testing and metrological traceability using established reference methods and calibrated instruments, not by expert interpretation of clinical data. The experts involved would be analytical chemists, biochemists, and statisticians with expertise in IVD manufacturing and assay development, rather than clinical experts like radiologists.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication (e.g., 2+1, 3+1 for clinical consensus) is used to resolve discrepancies in expert interpretation of clinical data. For a QC material, objective analytical measurements are the primary data source. Statistical methods are used to analyze the results and determine if they meet pre-defined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study is relevant for evaluating the impact of a diagnostic device (especially imaging or AI-driven) on human reader performance. Elecsys Troponin T CalCheck 5 is a quality control material, not a diagnostic device that humans interpret.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. This concept is specific to AI or algorithmic diagnostic devices. A quality control material like CalCheck 5 does not involve an algorithm with "standalone performance" in this context. Its function is to verify the performance of an analyzer/reagent system.

7. Type of Ground Truth Used:

The "ground truth" for a quality control material is its analytically determined and metrologically traceable assigned value for each analyte (Troponin T in this case) at each control level. This value is established through a comprehensive process involving:
- Reference Methods: Often comparing results to a higher-order reference measurement procedure (e.g., isotope dilution mass spectrometry, if available and appropriate).
- Consensus Studies: Using multiple instruments and laboratories to generate a robust mean value.
- Certified Reference Materials (CRMs): Ensuring traceability to international or national standards.

8. Sample Size for the Training Set:

Not applicable. This device does not use machine learning or AI, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an AI/ML model.

In summary, the provided document pertains to regulatory clearance for a quality control material. The acceptance criteria and "studies" for such a device are fundamentally different from those for diagnostic or AI-powered medical devices. The focus is on analytical performance, stability, homogeneity, and traceability of the control material itself, rather than clinical performance based on patient data or expert interpretation.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

MAR 1 9 2010

Roche Diagnostics c/o Sarah Baumann Regulatory Affairs Consultant Roche Professional Diagnostics 9115 Hague Road, P.O. Box 50410 Indianapolis, IN 46250-0416, USA

Re: K092848 Elecsys Troponin T CalCheck 5 Trade/Device Name: Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: February 17, 2010 Received: February 18, 2010

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 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 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, -

Signature

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology 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): K092848

Device Name: Elecsys Troponin T CalCheck 5

Indications for Use:

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

Carol Benson

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

510(k) K092848

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Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.