ELECSYS FOLATE III CALCHECK 5

K094031 · Roche Diagnostics · JJX · Apr 27, 2010 · Clinical Chemistry

Device Facts

• Record ID: K094031
• Device Name: ELECSYS FOLATE III CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys Folate III 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 Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers. For prescription use only. The Elecsys Folate III CalCheck 5 is not intended to be used as a primary calibrator or routine control material.

Device Story

Elecsys Folate III CalCheck 5 is a lyophilized, multi-level assayed control material; consists of folic acid in human serum buffer matrix. Used in clinical laboratory settings to verify calibration and assay range of Elecsys Folate III reagent on Modular Analytics E170/cobas e 601 analyzers. Product is reconstituted with distilled/deionized water by laboratory personnel. Values are assigned via master calibration curve generated on analyzers; target values determined by median of duplicate testing across multiple analyzers. Not for use as primary calibrator or routine control. Provides quality assurance for folate immunoassay testing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized human serum matrix spiked with Folate. Designed for use with Elecsys and cobas e immunoassay analyzers. No specific materials, energy sources, or software algorithms described beyond its function as a quality control material.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys Folate III 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 HCG+β CalCheck 5 (k092168)

Submission Summary (Full Text)

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K0940531

APR 2 7 2010

## 510(k) Summary

| 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<br>name, address,<br>contact | Roche Diagnostics<br>9115 Hague Road, P.O. Box 50416<br>Indianapolis, IN 46250-0416<br>317-521-3577 |
| | Contact Person: Kelly Colleen O'Maine Adams<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Secondary Contact: Stephanie Greeman<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Date Prepared: December 29, 2009 |
| Device Name | Proprietary name: Elecsys Folate III CalCheck 5<br>Common name: Folate CalCheck 5<br>Classification name: Single (specified) analyte controls (assayed and unassayed) |
| Predicate<br>device | The Elecsys Folate III CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys HCG+β CalCheck 5 (K092168). |
| Device<br>Description | The Elecsys Folate III CalCheck 5 is a lyophilized product consisting of Folate in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys Folate III 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 Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| | Continued on next page |

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS) in the USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

Roche Diagnostics c/o Kelly Colleen O'Maine Adams Regulatory Affairs Consultant 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0416

APR 2 7 2010

k094031 Re:

> Trade Name: Elecsys Folate III CalCheck 5 Regulation Number: 21 CFR 8862,1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I. Reserved Product Codes: JJX Dated: March 10, 2010 Received: March 11, 2010

Dear Mrs. O'Maine Adams:

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 (QS) 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.

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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## Indication for Use

510(k) Number (if known):

Device Name: Elecsys Folate III CalCheck 5

Indication For Use:

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

Prescription Use _ X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol Benson
Division Sign Off

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

510(k) K094031

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