LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the 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 it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines that resemble both faces and waves. 20 Ro Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Carol Ruggiero Director of Regulatory Affairs CLINIQA Corporation 1432-B South Mission Road Fallbrook, CA 92028 Re: k033162 Trade/Device Name: LiniCAL™ Chemistry Calibration Verifiers Levels A- E for Olympus AU Systems "M Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 26, 2003 Received: September 30, 2003 OCT 1 0 2003 Dear Ms Ruggiero: 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. Iisting 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}------------------------------------------------ 510(k) Number (if known): Device Name: LiniCAL™ Chemistry Calibration Verifiers Levels A – E for Olympus AU Systems ™ Indications For Use: CLINIQA LiniCAL™ Chemistry Calibration Verifiers Levels A - E for Olympus AU Systems™ are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems™ for Albumin, Blood Urea Nitrogen, Calcium, Creatinine, Magnesium, Phosphorus, Total Protein, Triglycerides, Glucose, Iron, Sodium, Chloride, and Potassium at five useful concentrations. Allato Sely Division Sign-Off Division Sign-Off for Lean Expedite S.Cr. Life Diagnostic Device Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K033162 (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