ELECSYS MYOGLOBIN CALCHECK 5

{0}------------------------------------------------ ## 510(k) Summary SEP 1 4 2011 · | 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, P.O. Box 50416<br>Indianapolis, IN 46250-0416<br>317-521-3501 | | | Contact Person: Kelly Colleen O'Maine Adams<br>Phone: 317-521-3577<br>Fax: 317-521-2324<br>Email: colleen.adams@roche.com | | | Secondary Contact: Stephanie Greeman<br>Phone: 317-521-2458<br>Fax: 317-521-2324<br>Email: stephanie.greeman@roche.com | | | Date Prepared: July 22, 2011 | | Device Name | Proprietary name: Elecsys Myoglobin CalCheck 5<br>Common name: Myoglobin CalCheck 5<br>Classification name: Single (specified) analyte controls (assayed and unassayed) | | Predicate device | The Elecsys Myoglobin CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys Digoxin CalCheck 5 (K102044). | | Device Description | The Elecsys Myoglobin CalCheck 5 is a liquid product consisting of human myoglobin in a buffer/protein (bovine serum) matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. | | Intended use | The Elecsys Myoglobin 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 Myoglobin reagent on the indicated Elecsys and cobas e immunoassay analyzers. | | | Continued on next page | {1}------------------------------------------------ ## 510(k) Summary, Continued Comparison Table The table below compares Elecsys Myoglobin CalCheck 5 with the predicate devices, Elecsys Digoxin CalCheck 5 (K102044). | Characteristic | Elecsys Myoglobin CalCheck 5<br>(Candidate) | Elecsys Digoxin CalCheck 5<br>(K102044) | |----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The Elecsys Myoglobin Calcheck 5 is<br>an assayed control for use in<br>calibration verification and for use in<br>the verification of the assay range<br>established by the Elecsys Myoglobin<br>reagent on the indicated Elecsys and<br>cobas e immunoassay analyzers. | The Elecsys Digoxin Calcheck 5 is an<br>assayed control for use in calibration<br>verification and for use in the<br>verification of the assay range<br>established by the Elecsys Digoxin<br>reagent on the indicated Elecsys and<br>cobas e immunoassay analyzers. | | Analyte | Myoglobin | Digoxin | | Levels | Five | Same | | Format | Liquid | Same | | Handling | Mix gently by inversion to ensure<br>homogeneity. | Same | | Stability | Unopened:<br>• Store at 2-8°C until expiration date<br>Opened:<br>• 20-25°C: 4 hours | Unopened:<br>• Same<br>Opened:<br>• 20-25°C: 6 hours | | Matrix | Bovine serum matrix | Same | Performance Characteristics The Elecsys Myoglobin CalCheck 5 was evaluated for value assignment and stability. {2}------------------------------------------------ Public Health Service Roche Diagnostics Ms. Kelly Colleen O'Maine Adams 9115 Hague Road Indianapolis, IN 46250-0416 Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 SEP 1 4 2041 Re: k112113 Trade/Device Name: Elecsys Myoglobin CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: 22 July, 2011 Received: 27 July, 2011 Dear Ms. 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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into class II (Special Controls), 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 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). 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. {3}------------------------------------------------ Page 2 - If you desire specific advice for your device on our labeling regulation (2) CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, prease the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Pari 802 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 responsible of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.hum 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 1011-free number (800) 638-204) 186-5680 or at its laternet address http://www.fda.gov/MedicalDevices/ResourcesSorYou/Industry/df('auti.htm. Sincerely yours. j Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indication for Use KII2113 510(k) Number (if known): Device Name: Elecsys Myoglobin CalCheck 5 Indication For Use: The Elecsys Myoglobin 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 Myoglobin 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 (OIVD) Signature of Offeror Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k 112113