URYXXON RELAX URINE ANALYZER

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. ## DEPARTMENT OF HEALTH & HUMAN SERVICES ## Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Macherey-Nagel GMBH & CO., KG. c/o Mr. Armond Welch Senior Regulatory Consultant AAC Consulting Group 7361 Calhoun Place, Suite 500 Rockville, MD 20855 SEP - 6 2006 Re: k061742 > Trade/Device Name: URYXXON Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL, KQO, JIP, CDM, CEN, JIN, JIR, JJB, JMA, JMT, KSL, LJX Dated: August 9, 2006 Received: August 15, 2006 Dear Mr. Welch: 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 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) 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 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 (PMA), it may be subject 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 equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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). {1}------------------------------------------------ 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 (240) 276-0484. 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/industry/support/index.html. Sincerely yours, Alberto Gutz Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use K 061742 510(k) Number: Device Name: URYXXON ## Indications for Use: The URYXXON® Relax is intended for use as an in vitro diagnostic aid using urine specimens for screening for diabetes metabolic abnormalities, liver diseases, biliary and hepatic obstructions of the kidneys and urinary tract. The test provided on MACHEREY-NAGEL Reagent strips for the determination of specific gravity, leucocytes, glucose, protein, blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen and urine color are considered routine urinalysis. Prescription Use (Per 21 CFR 801 Subpart D) OR Over-the Counter use (21 CFR 807 Subpart C) (Please do not write below this line-Continue on other page if needed) Concurrence of CDRH, office of in Vitro Diagnostic Devices (OIVD) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety k061742