URYXXON 200 URINE ANALYZER

{0}------------------------------------------------ 510(k) SUMMARY Page 1 / 2 K051034 ## 510 (k) SUMMARY | Introduction | According to the requirements established in the Food and Drug Admi-<br>nistration's guidance entitled "The New 510(k) Paradigm: Alternate<br>Approaches to Demonstrating Substantial Equivalence in Premarket<br>Notifications", the following information provides sufficient detail to<br>understand the basis for a determination of substantial equivalence. | | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | 1) Submitter<br>name, address, contact | MACHEREY-NAGEL GmbH & Co. KG<br>Valencienner-Strasse 11<br>D-52355 Dueren<br>GERMANY | | | | Submitter's Name: | Dietmar Czyron | | | Contact Person U.S.: | Eduardo March<br>Phone: 301-838-3120    Facs.: 301-838-3182 | | | Date Prepared: March 14, 2005 | | | | Proprietary Name: | URYXXON® 200 | | | Common Name: | Urine Chemistry Analyzer | | | Classification Name: | System, Automated Urinalysis, 75KQO<br>Class I ; Urinary Glucose Test System, 75JIL, Class<br>II | | 3) Predicate device | We claim substantial equivalence to the currently market CLINITEK® 50<br>Urine Analyzer, manufactured by Bayer Corp. (K960546). | | | 4) Device Description | The URYXXON® 200 Urine Analyzer is a reflectance photometer for in-<br>vitro semi-quantitative reading of Medi-Test Combi 11 urine test strips for<br>the following analytes: blood, urobilinogen, bilirubin, protein, nitrite,<br>ketones, ascorbic acid, glucose, pH, specific gravity and leucocytes. | | | 5) Intended use | In-vitro, semi-quantitative determination of urine analytes in clinical<br>laboratories and point-of-use settings. | | | 6) Comparison to<br>predicate device | The table below indicates the similarities between the URYXXON® 200<br>Urine Analyzer and predicate devices, the CLINITEK® 50 Urine Analyzer<br>and URYSIS 1100 Urine Analyzer | | | Topic | URYXXON® 200 | CLINITEK® 50 | |--------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------| | Intend of Use | In-vitro semi-quantitative determination of urine<br>analytes | Same | | Scientific<br>Technology | Reflectance Photometer | Same | | Urine Test Strips | Medi-Test Combi 11 (K991927) | Bayer MULTISTIX®<br>10-SG | | Test Parameters | Blood, urobilinogen, bilirubin, protein, nitrite,<br>ketones, ascorbic acid, glucose, pH, specific<br>gravity and leucocytes | Same, except ascorbic<br>acid | {1}------------------------------------------------ | 7) Difference to predicate<br>device | The URYXXON® 200 Urine Analyzer additionally measures ascorbic<br>acid (vitamin C). | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Provides high-speed thermo-transfer printer. | | 8) Statement of<br>Substantial Equivalence | MACHEREY-NAGEL has presented information of the techno-<br>logical principles, performance specifications, indications for use<br>and results of clinical testing that demonstrate the substantial<br>equivalence of the URYXXON® 200 to the predicate devices. | · : . - {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with stylized wings. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 NOV 2 2 2005 Macherey-Nagel GmbH & Co. KG c/o Mr. Eduardo March Senior Consultant AAC Consulting Group 7361 Calhoun Place, Suite 500 Rockville, MD 20855-2765 k051034 Re: Trade/Device Name: URYXXON 200 Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL, JIP, CDM, CEN, JIN, JIR, JJB, JMA, JMT, KSL, LJX, KQO Dated: October 21, 2005 Received: October 21, 2005 Dear Mr. March: 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). {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 (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 Alberto Gutierrez, Ph.D. 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 {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ URYXXON_200 Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: The URYXXON® 200 is a portable reflectance photometer that instrumentally measures. The The ORTAXON 20015 a reacted Medi-Test Combi 11 Reagent Strip for Urinalysis. The the reliectance on a reacted mour root online and using urine specimens for product is intended for use an in hard dities, liver diseases, biliary and hepatic obstructions and diseases of the kidneys and urinary tract. The test provided on Macherey-Nagel Reagent Strips for the determination of specific The lest provided on Macheroy Ning blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen and urine color are considered routine urinalysis Sign Off Division Sign-Off AND/OR Office of In Vitro Diagnostic Device Office tion and Safety 310(k) Ko51034 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)