ELECSYS FERRITIN CALCHECK 5

K102267 · Roche Diagnostics · JJX · Sep 10, 2010 · Clinical Chemistry

Device Facts

• Record ID: K102267
• Device Name: ELECSYS FERRITIN CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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

Device Story

Elecsys Ferritin CalCheck 5 is an assayed quality control product consisting of five levels of human ferritin in a human serum matrix. It is used in clinical laboratories to verify the calibration and reportable assay range of the Elecsys Ferritin reagent on Modular Analytics E170/cobas e 601 and Elecsys 2010/cobas e 411 analyzers. The device provides target values for ferritin concentrations ranging from <2 ng/mL to 1970 ng/mL. Healthcare providers use the output to ensure the accuracy and linearity of the immunoassay system during routine testing, supporting reliable ferritin measurement for patient diagnosis and monitoring.

Clinical Evidence

No clinical data. Bench testing only. Value assignment was performed by duplicate runs on multiple analyzer platforms (Modular Analytics E170/cobas e 601 and Elecsys 2010/cobas e 411). Stability was validated via accelerated and real-time studies.

Technological Characteristics

Liquid control material; human liver ferritin in human serum matrix; five concentration levels; stored at 2-8°C; intended for use on Elecsys and cobas e immunoassay analyzers.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys Ferritin reagent on specified Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic and prescription use.

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 Ferritin CalCheck (K981281)

Submission Summary (Full Text)

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Roche Diagnostics

K102267 Elecsys® Ferritin CalCheck 5

# 510(k) Summary

SEP 1_0 2010

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics<br>9115 Hague Road, P.O. Box 50416<br>Indianapolis, IN 46250-0416<br>317-521-3501<br><br>Contact Person: Sarah Baumann<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br><br>Secondary Contact: Stephanie Greeman<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br><br>Date Prepared: August 6, 2010 |
| Device name | Proprietary name: Elecsys® Ferritin CalCheck 5<br>Common name: Ferritin CalCheck 5<br>Classification name: Single (specified) analyte controls (assayed and<br>unassayed) |
| Predicate<br>device | The Elecsys Ferritin CalCheck 5 is substantially equivalent to other products<br>in commercial distribution intended for similar use. We claim equivalency to<br>the currently marketed Elecsys Ferritin CalCheck (K981281). |
| Device<br>description | The Elecsys Ferritin CalCheck 5 is a liquid product consisting of ferritin from<br>human liver in a human serum matrix. During manufacture, the analyte is<br>spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys Ferritin CalCheck 5 is an assayed control for use in calibration<br>verification and for use in the verification of the assay range established by<br>the Elecsys Ferritin reagent on the indicated Elecsys and cobas e<br>immunoassay analyzers. |
| | Continued on next page |

.

Confidential

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### 510(k) Summary, Continued

Table 1 below presents the similarities between Elecsys Ferritin CalCheck 5 Device and the predicate device, Elecsys Ferritin CalCheck (K981281). comparisonsimilarities

| Table 1. Device Comparison-Similarities between Candidate and Predicate Devices | | | |
|---------------------------------------------------------------------------------|--|--|--|
| | | | |

| Characteristic | Elecsys Ferritin CalCheck 5<br>(Candidate Device) | Elecsys Ferritin CalCheck<br>(K981281) |
|----------------|---------------------------------------------------|----------------------------------------|
| Analyte | Ferritin (human liver) | Same |
| Format | Liquid | Same |
| Handling | Mix gently by inversion to ensure<br>homogeneity. | Same |
| Matrix | Human serum matrix | Same |

| Device | Table 2 below presents the differences between Elecsys Ferritin CalCheck 5 |
|----------------------------|----------------------------------------------------------------------------|
| comparison-<br>differences | and the predicate device, Elecsys Ferritin CalCheck (K981281). |

| Table 2. Device Comparison-Differences between Candidate and Predicate Devices | | |
|--------------------------------------------------------------------------------|--|--|
|--------------------------------------------------------------------------------|--|--|

| Characteristic | Elecsys Ferritin CalCheck 5<br>(Candidate Device) | Elecsys Ferritin CalCheck<br>(K981281) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys Ferritin Calcheck 5<br>is an assayed control for use in<br>calibration verification and for<br>use in the verification of the<br>assay range established by the<br>Elecsys Ferritin reagent on the<br>indicated Elecsys and cobas e<br>immunoassay analyzers. | For use in the verification of the<br>calibration established by the<br>Elecsys Ferritin reagent on<br>Elecsys 1010 or 2010<br>immunoassay analyzers. |
| Levels | Five | Three |
| Stability | Unopened:<br>• Store at 2-8°C until expiration<br>date | Unopened:<br>• Store at 2-8°C until expiration<br>date |
| | Opened:<br>• 20-25°C: 4 hours | Opened:<br>• 20-25°C: 5 hours |

Continued on next page

Confidential

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## 510(k) Summary, Continued

| Performance<br>characteristics | The Elecsys Ferritin CalCheck 5 was evaluated for value assignment and<br>stability. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The data demonstrate that the performance of the Elecsys Ferritin CalCheck 5<br>is substantially equivalent to that of the predicate device, Elecsys Ferritin<br>CalCheck (K981281). |

Confidential

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Roche Diagnostics c/o Sarah Baumann 9115 Hague Road Indianapolis, IN 46250

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

SEP 1 0 2010

Re: k102267

> Trade Name: Elecsys Ferritin 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: August 6, 2010 Received: August 9, 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 (sec above) into cither 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 Parts 801 and 809), 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 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 [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

C.C.

Courtney 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): _ K / 022267

SEP 1 0 2010

Device Name: Elecsys Ferritin CalCheck 5

Indications for Use: The Elecsys Ferritin 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 Ferritin reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Prescription Use Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Carol Benson

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

510(k) K102267

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