EXTENDED RANGE HS CRP KIT, CAT NO:9200

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. SEP 3 0 2003 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Joseph Lawlor, Ph.D. Reference Diagnostics, Inc. 19 Crosby Drive – Suite 30 Bedford, MA 01730 Re: k030044 > Trade/Device Name: RDI Extended Range hs CRP Kit (C-reactive protein) Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK Dated: July 7, 2003 Received: July 8, 2003 Dear Dr. Lawlor: 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 (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 I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the text "Ref.Dx" with a diagonal line striking through the "x". Below the text, there is a grid pattern that is partially filled in, creating a triangular shape. The diagonal line extends down through the grid pattern. ## REFERENCE DIAGNOSTICS, INC. 19 Crosby Drive, Suite 30 Bedford, Massachusetts 01730 Tel 781 276-9000 Fax 781 276-9002 Statement of Intended Use Page 1 of 1 510(k) Number (if known): K030044 RDI Extended Range hs CRP Kit (C-reactive protein) Device Name: ## Indications For Use: For in vitro diagnostic use only. The RDI Extended Range hs CRP Kit is for the quantitative determination of C-reactive protein in human serum or plasma by immunoturbidimetric measurement. ## Summary and Explanation of the Test: Measurement of CRP helps in detecting and evaluating infection, tissue injury, inflammatory disorders, and associated diseases. (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 Sean Cooper (Division Sign-Off) Division of Clinical Laboratory Devices, 510(k) Number K030544