OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS) in the USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three abstract human figures. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 FEB 0 8 2002 Mr. Michael Campbell Manager, Regulatory Affairs/Quality Assurance Olympus America Inc Diagnostic Systems Group 3131West Royal Lane Irving Texas 75063-3104 k014015 Re: > Trade/Device Name: Olympus HDL Cholesterol Test System Regulation Number: 21 CFR 862.1475; 21 CFR 862.1150; 21 CFR 862.1660 Regulation Name: Lipoprotein test system; Calibrator; Quality control material (assayed or unassayed) Regulatory Class: Class I; Class II; Class I (reserved) Product Code: LBS; JIT; JIX Dated: January 18, 2002 Received: January 22, 2002 Dear Mr. Campbell: 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Page 2 - This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you of substantial equivalence of your device to a legally marketed nouticate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (201) 594-1500. Treatures of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small nuonnation on your respond 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 Putman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Statement 510(k) Number (if known): K014015 Device Name: Olympus HDL Cholesterol Test System Contents: Olympus HDL Cholesterol Reagent Olympus HDL Cholesterol Calibrator Olympus HDL/LDL Cholesterol Control Indications for Use: The Olympus HDL Cholesterol Test System contains HDL Cholesterol Reagent, HDL Cholesterol Calibrator, and Assayed HDL/LDL Cholesterol Control materials intended for use on the Olympus Family of Clinical Chemistry Analyzers for the quantitative determination of HDL Cholesterol concentrations in human serum and plasma. The Olympus HDL Cholesterol Calibrator is a lyophilized human serum intended to provide an HDL concentration of known value for use in calibration of the Olympus HDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers. The Olympus HDL/LDL Cholesterol Control consists of lyophilized human sera. These assayed control sera are designed to monitor the recovery and precision of the Olympus HDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers. HDL Cholesterol demonstrates a strong and independent association with the risk of coronary artery disease and is used in the initial screening for hypercholesterolemia. Ha (Division Sign-Off) Division of Clinical Laborat 510(k) Number K014015 (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) ============================================================================================================================================================================== --------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) V OR Over-The-Counter Use Prescription Use (per 21 CFR 801.109) (Optional Format 1-2-96)