ROCHE ONLINE TDM LIDOCAINE

{0}------------------------------------------------ JAN 1 2 2004 # Roche ONLINE Lidocaine Assay # 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 | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>(317) 845-2000 | | | Contact Person: Mike Flis | | | Date Prepared: July 28, 2003 | | 2) Device name | Roche ONLINE TDM Lidocaine | | 3) Predicate device | We claim substantial equivalence to the Roche COBAS INTEGRA Lidocaine [K954992]. | | 4) Device Description | The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with lidocaine and rapidly aggregate in the presence of a lidocaine antibody solution. When a sample containing lidocaine is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formulation is inhibited. Thus, a classic inhibition curve with respect to lidocaine concentration is obtained, with the maximum rate of aggregation at the lowest lidocaine concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained. | Continued on next page {1}------------------------------------------------ ## 510(k) Summary, Continued | 5) Intended use | For the quantitative determination of lidocaine in human serum or plasma on<br>automated clinical chemistry analyzers. | | | | | | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--|--|--|--| | 6) Comparison<br>to predicate<br>device | The Roche ONLINE TDM Lidocaine was evaluated for several performance<br>characteristics, including precision, lower detection limit, method<br>comparison, specificity, and interfering substances. All of the evaluation<br>studies gave acceptable results compared to the predicate device. These<br>experiments provide evidence that the Roche ONLINE TDM Lidocaine is<br>substantially equivalent to the currently marketed Roche COBAS INTEGRA<br>Lidocaine Assay. The following table presents the precision and method<br>comparison results. | | | | | | | | Roche ONLINE TDM Lidocaine | Roche COBAS INTEGRA Lidocaine,<br>(Predicate labeling) | | | | | | | Roche ONLINE TDM Lidocaine | Roche COBAS INTEGRA Lidocaine,<br>(Predicate labeling) | | | | | |---------------------|------------------------------------------------------------------|--------------------------------------------------------|---------|---------|---------|---------| | | Versus Roche COBAS INTEGRA Lidocaine<br>Assay (predicate device) | Versus FPIA method | | | | | | | N = 99 | N = 69 | | | | | | | $Y = 1.019X-0.044$ | $Y=0.947X + 0.011$ | | | | | | | R = 0.995 | R= 0.991 | | | | | | | Range = 0.40 to 9.56 µg/mL | | | | | | | NCCLS<br>Precision: | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | | Mean (µg/mL) | 1.34 | 4.47 | 7.03 | 1.45 | 3.54 | 8.09 | | CV% (within run) | 2.7 | 1.5 | 1.9 | 1.92 | 1.90 | 2.99 | | CV% (total) | 6.0 | 3.4 | 3.6 | 2.30 | 2.07 | 3.75 | {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The text is arranged in a circular pattern around the symbol. Public Health Service JAN 1 2 2004 Food and Drug Administrat 2098 Gaither Road Rockville MD 20850 Mr. Mike Flis Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457 k032334 Re: Trade/Device Name: Roche ONLINE TDM Lidocaine Assay Regulation Number: 21 CFR 862.3555 Regulation Name: Lidocaine test system Regulatory Class: Class II Product Code: KLR Dated: October 31, 2003 Received: November 4, 2003 Dear Mr. Flis: 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 ror use stated or the 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 r ou may, atteres, 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 (PMA), it your deviloget 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 cquivalence determination does not mean r reaso be actived a determination that your device complies with other requirements of the Act that I Drillaral 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {3}------------------------------------------------ Page 2 - 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. If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Sutman Steven 1. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Hcalth Enclosure {4}------------------------------------------------ ### Roche Diagnostics Corporation 510(k) Number (if known): K032334 Device Name: Roche ONLINE TDM Lidocaine Assay Indications for Use: The Roche ONLINE TDM Lidocaine assay is for the quantitative determination of lidocaine in human serum or plasma on automated clinical chemistry analyzes. Lidocaine is an antiarrhythmic agent administered intravenously by either injection or continuous infusion. It is indicated in the acute management of ventricular arritythmias such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Lidocaine reagent kits. #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF 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 Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K032334 3/3