ELECSYS TROPONIN T CALCHECK 5

K092848 · Roche Diagnostics Corp. · JJX · Mar 19, 2010 · Clinical Chemistry

Device Facts

• Record ID: K092848
• Device Name: ELECSYS TROPONIN T CALCHECK 5
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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. For in vitro diagnostic use. For prescription use only. The Elecsys Troponin T CalCheck 5 is not intended to be used as a primary calibrator or routine control material.

Device Story

Elecsys Troponin T CalCheck 5 is an assayed quality control material used to verify calibration and assay range for Troponin T reagents on Elecsys and cobas e immunoassay analyzers. It functions as a reference standard to ensure analytical performance within established ranges. Used by laboratory professionals in clinical settings to validate system accuracy. Does not provide diagnostic results directly; serves as a quality assurance tool to confirm instrument performance before patient sample testing.

Clinical Evidence

No clinical data. Bench testing only. Performance established via traceability to internal reference material and recovery analysis on reference analyzers (Elecsys 2010 and E170) to confirm target values and stability.

Technological Characteristics

Lyophilized recombinant human cardiac Troponin T in human serum matrix. Five concentration levels (Level 1: <0.01 ng/mL to Level 5: 25.0 ng/mL). Reconstitution required (1.0 mL distilled/deionized water). Stability: 18 months unopened at 2-8°C; 4 hours reconstituted at 20-25°C. Analyte traceable to internal reference material.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys Troponin T reagent on Elecsys and cobas e immunoassay analyzers. Not for use as a primary calibrator or routine control material.

Regulatory Classification

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.

Predicate Devices

• Elecsys Troponin T CalCheck 5 (K040373)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services USA. The logo features the department's emblem, which is a stylized human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the emblem in a circular fashion.

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 [phone]. 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 [phone]. 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 [phone] 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:

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.

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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