ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844

{0}------------------------------------------------ K981883 : JUL 7 1998 ලෙස පොදුන් # 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) Submitter<br>name, address,<br>contact | Roche Diagnostics, Boehringer Mannheim Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>(317) 845-2000 | | | Contact Person: Luann Ochs | | | Date Prepared: May 28, 1998 | | 2) Device name | Proprietary name: Roche Diagnostics, Boehringer Mannheim Liquid Direct<br>Bilirubin Reagent | | | Common name: bilirubin (total or direct) test system | | | Classification name: Diazo colorimeter, bilirubin, 75CIG<br>Device Class II | | 3) Predicate<br>device | We claim substantial equivalence to the currently marketed Roche Diagnostics,<br>Boehringer Mannheim Direct Bilirubin reagent system, catalog number<br>704027, a modification of the Boehringer Mannheim / Hycel Bilirubin II<br>reagent system, included in K790335. | | 4) Device<br>Description | Direct bilirubin, in the absence of a suitable solubilizing agent, is coupled with<br>a diazonium ion in a strongly acid medium (pH 1 - 2). | | | Bilirubin + diazonium ion <span style="text-decoration:underline;">acid</span> -> Azobilirubin | | | The intensity of the color of the azobilirubin formed is proportional to the<br>direct bilirubin concentration and can be measured photometrically. | Continued on next page ﺎﺕ ﺳ {1}------------------------------------------------ # 510(k) Summary, Continued The Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin reagent 5) Intended use is intended for use for the quantitative determination of direct bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers. The Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin reagent 6) Comparison is substantially equivalent to other products in commercial distribution to predicate intended for similar use. Most notably it is substantially equivalent to the device currently marketed Roche Diagnostics, Boehringer Mannheim Direct Bilirubin reagent system, catalog number 704027, a modification of the Boehringer Mannheim / Hycel Bilirubin II reagent system, included in K790335. > The following table illustrates the similarities between the Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin Reagent and the predicate device. Specific data on the performance of the system have been incorporated into the draft labeling in Section V of this submission. Labeling for the predicate device is provided in Section VI. | Feature | New Liquid Direct<br>Bilirubin Reagent | Predicate Direct<br>Bilirubin Reagent | |------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | Intended Use | Measurement of direct<br>bilirubin | Measurement of direct<br>bilirubin | | Sample Type | Serum or plasma, no<br>preparation required | Serum or plasma, no<br>preparation required | | Use on Automated<br>Chemistry Analyzers? | Yes | Yes | | Test Principle | Diazo reaction with<br>formation of an<br>azobilirubin product,<br>measured<br>spectrophotometrically | Diazo reaction with<br>formation of an<br>azobilirubin product,<br>measured<br>spectrophotometrically | | Calibration | Uses commercially<br>available calibrators<br>with assigned values for<br>direct bilirubin | Uses commercially<br>available calibrators<br>with assigned values for<br>direct bilirubin | ### Similarities: Continued on next page {2}------------------------------------------------ ## 510(k) Summary, Continued | Feature | New Liquid Direct<br>Bilirubin Reagent | Predicate Direct<br>Bilirubin Reagent | |-------------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Calibration Stability | Perform a new<br>calibration once a week,<br>or with a bottle or<br>reagent lot change | Perform a new<br>calibration once daily,<br>or with a bottle or<br>reagent lot change | | Reagent On-board<br>Stability | 4 weeks | 14 days | | Kit Configuration,<br>Reagent Preparation | R1, liquid, ready-to-use<br>R2, liquid, ready-to-use | R1, liquid, ready to use<br>R2, combine bottles 2<br>(sulfanilic) and 2a<br>(nitrite), then add 2b<br>(diluent) | 6) Comparison to predicate device (continued) ### 6) Comparison to predicate device, continued #### Differences: There are no significant differences between the Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin reagent and the predicate device for purposes of considering substantial equivalence. #### Performance characteristics: The performance of the Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin reagent is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Roche Diagnostics, Boehringer Mannheim Direct Bilirubin reagent system, catalog number 704027, a modification of the Boehringer Mannheim / Hycel Bilirubin II reagent system, included in K790335. {3}------------------------------------------------ Image /page/3/Picture/10 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. 7 1998 JUL Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Luann Ochs Clinical Research Manager Roche Diagnostics, Boehringer Mannheim Corporation 9115 Haque Road Indianapolis, Indiana 46256 Re : K981883 Liquid Direct Bilirubin Reagent Requlatory Class: II Product Code: CIG Dated: May 28, 1998 Received: May 29, 1998 Dear Ms. Ochs: 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, Druq, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ್ಗ 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 QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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. {4}------------------------------------------------ Page 2 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 qeneral 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 "dsmo@fdadr.cdrh.fda.qov". Sincerely yours, Steven Autman 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 {5}------------------------------------------------ 510(k) Number (if known): Device Name: Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin Reagent Indications for Use: The Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin reagent is intended for use for the quantitative determination of direct bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers. According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1110, a bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use | |------------------------------------------|----|--------------------------| | | | (Optional Format 1-2-96) | Division of Clinical Laboratory Devices | 510(k) Number: | k981883 | |----------------|---------| |----------------|---------|