BM PRECIPATH(R) HDL/LDL-C CONTROL

{0}------------------------------------------------ ## 510(k) Summary ## JAN 22 1998 K9774826 According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Boehringer Mannheim Corporation 1) Submitter name, address, 9115 Hague Rd contact Indianapolis, IN 46250 (317) 845-2386 Contact person: Edward R. Kimmelman Date prepared: Dec. 23, 1997 2) Device name Proprietary name: Boehringer Mannheim Precipath® HDL/LDL-C Common name: BM Precipath® HDL/LDL-C Classification name: Multi-Analyte Controls, All Kinds (Assayed and Unassaved) 3) Predicate We claim substantial equivalence to the Sigma Diagostics Cardiolipid™ device Controls. The intended use of the above controls is monitoring and control of processes for measuring the lipoproteins. HDL-C and LDL-C. The Boehringer Mannheim Precipath® HDL/LDL-C Control consists of 4) Device description lyophilized human serum with added HDL-Cholesterol and LDL-Cholesterol. The Boehringer Mannheim Precipath® HDL/LDL-C Control is intended to be 5) Intended use used in the monitoring and control of processes for measuring HDL-C and LDL-C. Continued on next page 11:43 : {1}------------------------------------------------ ## 510(k) Summary, Continued The Boehringer Mannheim Precipath® HDL/LDL-C control is substantially 6) Comparison equivalent to other products in commercial distribution intended for similar to the predicate device use. Most notably, it is substantially equivalent to the currently marketed Sigma Diagnostics Cardiolipid™ Controls. > The intended use of this BM control and the predicate devices is the same in that they are intended to be used for the monitoring and control of test systems for the measurement of their labeled analytes. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JAN 2 2 1998 Edward R. Kimmelman · Program Director, Regulatory Affairs and Compliance Boehringer Mannheim Corporation 9115 Haque Road Indianapolis, Indiana 46250 K974826 Re: Precipath® HDL/LDL-C Control Requlatory Class: I JJY, LBS Product Code: Dated: December 23, 1997 Received: December 24, 1997__ _ - - Dear Mr. Kimmelman: 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, 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 Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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. {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 Also, please note the Office of Compliance at (301) 594-4639. 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 Litman 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}------------------------------------------------ 510(k) Number (if known): K974826 Device Name: Boehringer Mannheim Precipath® HDL/LDL-C Control Indications for Use: For the monitoring and control of processes for measuring the lipoproteins, HDL-C and LDL-C. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter Use __ (Optional format 1-2-96) Division Sign-Off) vision of Clinical Laboratory Device: 510(k) Number. k974826 16