LINICAL ESOTERICS 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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a person embracing or supporting another figure. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 FEB 2 3 2004 Ms. Carol Ruggiero Director of Regulatory Affairs CLINIQA Corporation 1432 South Mission Road Fallbrook, CA 92028 k040091 Re: K040071 Trade/Device Name: LiniCALTM Esoterics Calibration Verifiers Levels A – E for Olympus AU Systems™ Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: January 13, 2004 Received: January 16, 2004 Dear Ms. Ruggiero: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases 976, the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, and excordance with the provisions of the Federal Food, Drug, devices that have been reciasined require approval of a premarket approval application (PMA). and Costicule Act (110.) that to nevies, subject to the general controls provisions of the Act. The r our may, diererere, mains of the Act include requirements for annual registration, listing of general controls proving 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 If your device is olusified (600 acc roy ols. Existing major regulations affecting your device can may oe subject to suel adentifical 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 r lease oc advised that 1 Dr. 5 issuanted evour device complies with other requirements of the Act that I Dri has made a avoid regulations administered by other Federal agencies. You must of any I cut all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Tec of CFR Parts 801 and 809); and good manufacturing practice CFR Part 807), iaooning (21 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 has letter with and in yourse FDA finding of substantial equivalence of your device to a legally prematicated 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, If You desire spoonie navertising 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 Tou may 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, Jean M. Cooper, US, DVM. Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology 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™ Esoterics Calibration Verifiers Levels A – E for Olympus AU Systems™ Indications For Use: CLINIQA LiniCAL™ Esoterics 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 Ammonia, Ethanol, Microalbumin, Salicylate, and Urinary/CSF Protein at five useful concentrations. Alberto Lutz **Division Sign-Off** Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K040091 (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