ELECSYS PROBNP II CALCHECK 5

K092169 · Roche Diagnostics · JJX · Dec 16, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092169
• Device Name: ELECSYS PROBNP II CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys proBNP II 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 proBNP II reagent on the indicated Elecsys and cobas e immunoassay analyzers. For prescription use only. The Elecsys proBNP II CalCheck is not intended to be used as a primary calibrator or routine control material.

Device Story

Elecsys proBNP II CalCheck 5 is a lyophilized, assayed quality control material; consists of NT-proBNP (1-76) amide spiked into human serum and potassium phosphate buffered matrix. Used in clinical laboratory settings by laboratory professionals to verify calibration and assay range of Elecsys proBNP II reagent on Elecsys and cobas e immunoassay analyzers. Product requires reconstitution with distilled or deionized water before use. Provides five concentration levels to support expanded range verification compared to the three-level predicate. Helps ensure accuracy and reliability of proBNP immunoassay results, supporting clinical decision-making for cardiac conditions.

Clinical Evidence

No clinical data. Bench testing only. Stability testing (real-time and accelerated) confirmed shelf-life and reconstituted stability. Value assignment performed using multiple Elecsys/cobas e analyzer systems to establish target values.

Technological Characteristics

Lyophilized synthetic NT-proBNP in human serum/buffer matrix. Five levels. Storage: 2-8°C unopened; 4 hours at 20-25°C reconstituted. Compatible with Elecsys 2010/cobas e411 and MODULAR ANALYTICS E 170/cobas e 601 systems.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys proBNP II reagent on Elecsys and cobas e immunoassay analyzers.

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 proBNP II CalCheck (k080147)

Submission Summary (Full Text)

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K092169

DEC 162009

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510(k) Summary

DEC 16 2009

| 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 Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250<br>317-521-3208 |
| | Contact Person: Kelly French |
| | Date Prepared: July 15, 2009 |
| Device Name | Proprietary name: Elecsys proBNP II CalCheck 5 |
| | Common name: proBNP II CalCheck 5 |
| | Classification name: Single (specified) analyte controls (assayed and unassayed) |
| Predicate device | The Elecsys proBNP II CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys proBNP II CalCheck (K080147). |
| Device Description | The Elecsys proBNP II CalCheck 5 is a lyophilized product consisting of NT-proBNP (1-76) amide, human serum and a potassium phosphate buffered matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys proBNP II 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 proBNP II reagent on the indicated Elecsys and cobas e immunoassay analyzers. |

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## 510(k) Summary, Continued

The table below compares Elecsys proBNP II CalCheck 5 with the predicate Comparison device, Elecsys proBNP II Calcheck (K080147). Table

| Characteristic | Elecsys proBNP II CalCheck<br>(K080147) | Elecsys proBNP II CalCheck 5 |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the verification of the<br>calibration established by the<br>Elecsys proBNP II reagent on the<br>Elecsys and cobas e immunoassay<br>analyzers. | The Elecsys proBNP II CalCheck<br>5 is an assayed control for use in<br>calibration verification and for use<br>in the verification of the assay<br>range established by the Elecsys<br>proBNP II reagent on the indicated<br>Elecsys and cobas e immunoassay<br>analyzers. |
| Levels | Three | Five |
| Format | Lyophilized | Same |
| Handling | Reconstitute with exactly 1.0 mL<br>distilled or deionized water and<br>allow standing closed for 15<br>minutes, then mixing gently. | Same |
| Stability | Unopened:<br>· Store at 2-8ºC until expiration<br>date<br>Reconstituted:<br>· 20 - 25 °C : 4 hrs | Same |
| Matrix | Human serum | Same |
| Buffer | Potassium phosphate buffer | Same |

Performance Characteristics The Elecsys proBNP II CalCheck 5 was evaluated for value assignment and stability.

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Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo consists of a stylized abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is positioned to the right of the text, which reads "DEPARTMENT OF HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text and symbol are both in black and are set against a white background.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Roche Diagnostics Roche Professional Diagnostics c/o Ms. Kelly French Regulatory Affairs Consultant 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0416

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

DEC 1 6 2009

k092169 Re:

> Trade Name: Elecsys proBNP II CalCheck 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: December 1, 2009 Received: December 2, 2009

Dear Ms. French:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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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 vours.

CA

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

510(k) Number (if known): k092169

Device Name: Elecsys proBNP II CalCheck 5

Indications For Use:

The Elecsys proBNP II 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 proBNP II reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Prescription Use X (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)

Carol Benan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety Koszlo 510(k)

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