MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR

{0}------------------------------------------------ JAN 20 1999 - K984425 ## 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. | 1) Submitter name, address, contact | Boehringer Mannheim Corporation<br>9115 Hague Rd<br>Indianapolis, IN 46250<br>(317) 845-2386 | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Contact person: Priscilla A. Hamill | | | Date prepared: December 9, 1998 | | 2) Device name | Proprietary name: Preciset® Serum Proteins | | | Common name: Preciset® Serum Proteins | | | Classification name: Calibrator, Multi-analyte mixture | | 3) Predicate device | We claim substantial equivalence to Preciset Serum Proteins calibrator, marketed by Boehringer Mannheim (K983469). The intended use of the above calibrators is the establishment of calibration curves for test systems for the quantitative determination of proteins in serum and plasma. | | 4) Device description | The Preciset® Serum Proteins consists of multi-level calibrators based on human serum. The concentrations of the components have been adjusted to ensure optimal calibration of the following immunoturbidimetric assays: Tina-quant® IgA, Tina-quant® IgG, Tina-quant® IgM, Tina-quant® C3, and Tina-quant® C4, Transferrin, and C-Reactive Protein (CRP). | | 5) Intended use | The Preciset® Serum Proteins calibrator is intended to be used in the calibration of immunoturbidimetric assays on the BM/Hitachi systems. | Continued on next page {1}------------------------------------------------ ## 510(k) Summary, Continued | 6) Comparison<br>to the predicate<br>device | The Preciset® Serum Proteins calibrator is substantially equivalent to other<br>products in commercial distribution intended for similar use. Most notably, it<br>is substantially equivalent to the currently marketed Boehringer Mannheim<br>Preciset Serum Proteins. | |--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The intended use of this BM calibrator and the predicate devices is the same<br>in that they are intended to be used for the calibration of test systems for the<br>measurement of their labeled analytes. | | Representative<br>levels of<br>constituent<br>analytes | The proposed product includes assayed values for constituent analytes.<br>Representative levels are indicated in the table below. | ## Representative Constituent Analyte Levels | Constituent | Level<br>1 | Level<br>2 | Level<br>3 | Level<br>4 | Level<br>5 | Units | |-------------|------------|------------|------------|------------|------------|-------| | IgG | 194 | 408 | 845 | 1622 | 2985 | mg/mL | | IgA | 50 | 94 | 193 | 400 | 723 | mg/mL | | IgM | 28 | 51 | 103 | 213 | 388 | mg/mL | | C3 | 38 | 70 | 147 | 305 | NA | mg/mL | | C4 | 6.4 | 12.4 | 26.1 | 54.9 | 99.3 | mg/mL | | Transferrin | 42 | 80 | 159 | 333 | 603 | mg/mL | | CRP | 0.6 | 1.3 | 2.2 | 11.2 | 29.2 | mg/mL | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JAN 20 1999 Ms. Priscilla A. Hamill Regulatory Affairs Consultant Boehringer Mannheim Corporation 9115 Hague Road Indianapolis, Indiana 46250 Re: K984425 Trade Name: Preciset® Serum Proteins Regulatory Class: II Product Code: JIX Dated: December 9, 1998 Received: December 11, 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 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). 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 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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. {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/dsma/dsmamain.html". Sincerely yours, Steven Putman 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}------------------------------------------------ R 984425 510(k) Number (if known): _ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Device Name: Preciset ® Serum Proteins Indications for Use: For calibration of immunoturbidimetric assays on BM/Hitachi systems Jean Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K984425 (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)