PYLO-PLUS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white. ## Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 MAY 1 2006 Mr. Philip Ross Vice President ARJ Medical, Inc. 209 State Street Oldsmar, FL 34677 k052708 Re: Trade/Device Name: Pylo-Plus Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter Fetus Serological Reagents ﻴﺔ: Regulatory Class: Class I Product Code: LYR Dated: March 19, 2006 Received: March 27, 2006 Dear Mr. Ross: 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, I/DA 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 mcan 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) I ms letter will anow you to oogin manceling of substantial equivalence of your device to a legally premarker notification: "The slassification 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 you desire specific modion and advertising of your device, please contact the Office of In of questions on the promosion ation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain 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, Sally a Horr Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Premarket Notification ARJ Medical, Inc Pylo-Plus 510(K) # K052708 ## STATEMENT OF INDICATIONS FOR USE 510(K) number: K052708 Device name: Pylo-Plus Pylo-Plus is intended for the qualitative detection of the urease enzyme in gastric I your id is intended for the presumptive determination of Helicobacter pylori in symptomatic patients. ARJ Medical's Pylo-Plus Rapid Urease Tests are for single use by medical and ANJ Medical 3 1 710 1 148 Rapia Created for use in screening at-risk patients to assist diagnosis in the field of Gastroenterology. AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ X Prescription Use _ (Part 21 CFR 801 Subpart D) (21 CFR 807 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) Division Sign-Off Office of In Vitro Diaga north L Evaluation and Safety 510(k) k052708