ELECSYS CALCHECK MYOGLOBIN

{0}------------------------------------------------ SEP 2 2 1998 Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The string is "K98316b". ## 510(k) Summary | 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. | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1.<br>Submitter<br>name, address,<br>contact | Boehringer Mannheim Corporation<br>9115 Hague Road<br>Indianapolis, IN 46250<br>(317) 845 - 3723 | | | Contact Person: Priscilla A. Hamill | | | Date Prepared: September 08, 1998 | | 2.<br>Device Name | Proprietary name: Elecsys CalCheck Myoglobin<br>Common name: Calibration Verification Material | | | Classification name: Single (specified) analyte controls (assayed +<br>unassayed) | | 3.<br>Predicate<br>device | The Boehringer Mannheim Elecsys CalCheck Myoglobin is substantially<br>equivalent to the currently marketed Elecsys CalCheck Troponin T. | | 4.<br>Device<br>Description | The Boehringer Mannheim Elecsys CalCheck Myoglobin is manufactured<br>using bovine serum albumin, human Myoglobin, stabilizers, and<br>preservatives. The analyte is appropriately spiked into the CalCheck matrix to<br>the correct CalCheck concentration levels. | {1}------------------------------------------------ ## 510(k) Summary, Continued | 5.<br>Intended use | The Boehringer Mannheim Elecsys® CalCheckTM Myoglobin is used to<br>verify the calibration assignment for the Boehringer Mannheim Elecsys<br>Myoglobin assay. | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 6.<br>Comparison to<br>predicate<br>device | The Boehringer Mannheim Elecsys® CalCheckTM Myoglobin is substantially<br>equivalent to other products in commercial distribution intended for similar<br>use. Most notably, it is substantially equivalent to the currently marketed<br>Elecsys® CalCheckTM Troponin T. | | | Both products are intended to be used for the verification of calibration for<br>analytes on the Elecsys immunoassay analyzers. | | 7. Performance<br>Characteristics | The Elecsys® CalCheckTM Myoglobin was evaluated for value assignment<br>and stability. | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICE . USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Priscilla A. Hamill Requlatory Affairs Consultant Boehringer Mannheim Corporation 9115 Haque Road P.O. Box 50457 Indianapolis, Indiana 46250-0457 Re : K983166 Elecsys® CalCheck™ Myoglobin Regulatory Class: I Product Code: JJY Dated: September 8, 1998 Received: September 10, 1998 Dear Ms. Hamill: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. SEP 2 2 1998 {3}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. This letter will allow you to begin marketing your device as described in your 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". sincerely yours, Steven Gutman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## K983166 510(k) Number (if known): N/A Device Name: Boehringer Mannheim-Elecsys® CalCheck™ Myoglobin Indications For Use: Elecsys CalCheck Myoglobin calibration verification solutions comprise three levels - low, mid, and high - each with a defined Myoglobin concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range. The Elecsys CalCheck Myoglobin is intended for use in periodic verification of the calibration of the Elecsys Myoglobin assay. Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)  (Division Sign-Off) Division of Clinical Laboratory Devices Division of Clinical Laboratory Devices 510(k) Number K983166