LIDOCAINE EIA ASSAY

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of unity or collaboration. The overall design is simple and professional, reflecting the official nature of the organization. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 SEP 1 2 1997 Yuh-geng Tsay, Ph.D. President Diagnostic Reagents, Inc. 601 California Avenue 94086 Sunnyvale, California Re: K973102 Lidocaine Enzyme Immunoassay Requlatory Class: II Product Code: KLR August 15, 1997 Dated: Received: August 19, 1997 Dear Dr. Tsay: 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. 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 requlation (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 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 . {1}------------------------------------------------ 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 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 "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 {2}------------------------------------------------ i10(k) Number (if known): LIDOCAINE ENZYME IMMUNOASSAY Device Name: Indications For Use: This homogeneous lidocaine enzyme immunoassay is intended to be used for quantitative determination of lidocaine in human serum or plasma. Monitoring serum or plasma lidocaine concentration is the most effective means of improving the drug efficacy and minimizing the risk of toxicity for patients under lidocaine treatment for certain cardiac arrhythmias. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) 510(k) Number: k973182 Prescription Use Per 21 CFR 801.109) ... ක්‍රි.වූ බැඳින් මෙය ක්‍රි... මෙය සිට පිහිටා විශ්වය විය... මෙම ප්‍රධාන පිහිටා විශ්වය විශ්වය විශ්වය විශ්වය විශ්වය විශ්වය විශ්වය විශ්වය විශ්වය විශ්වය විශ්වය විශ්වය විශ්වය ව OR Over-The-Counter Use (Optional Format 1-2-96)