HDL CHOLESTEROL (HDLX) ASSAY

{0}------------------------------------------------ K.000010 Summary of Safety & Effectiveness SYNCHRON® Systems HDL Cholesterol (HDLX) Reagent #### 1.0 Submitted By: MAY 1 4 2010 Yvette Llovd. JD Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 250 S. Kraemer Blvd Mail Stop: E2.SE.08 Brea, CA 92821 Phone: (714) 961-3626 (714) 961-4234 FAX: email: yrlloyd@beckman.com #### 2.0 Date Submitted: December 18, 2009 #### 3.0 Device Name(s): - 3.1 Proprietary Names SYNCHRON® Systems HDL Cholesterol (HDLX) Reagent - 3.2 Classification Name - LDL & VLDL precipitation, Cholesterol via esterase-oxidase, HDL (Product . Code - LBS; 21 CFR § 862.1475) #### 4.0 Predicate Device: | Candidate(s) | Predicate | Manufacturer | Docket<br>Number | |-----------------------------------------------------|----------------------------------|-----------------------------|------------------| | SYNCHRON® Systems HDL<br>Cholesterol (HDLX) Reagent | Olympus HDL Cholesterol<br>Assay | OLYMPUS<br>AMERICA,<br>INC. | K040692 | #### 5.0 Description: HDLX reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System(s) and Genzyme Liquid N-geneous® HDL Cholesterol Calibrator is intended for quantitative determination of HDL Cholesterol in the high density lipoprotein fraction of human serum or plasma. HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease. This direct HDL Cholesterol method is a homogeneous assay without the need for any offline pretreatment or centrifugation steps. The method depends on a unique detergent which solubilizes only the HDL lipoprotein particles and releases HDL cholesterol to react with cholesterol esterase and cholesterol oxidase in the presence of chromogens, to produce a color product. The same detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL, and chylomicrons lipoproteins by adsorbing to their surfaces. A polyanion contained in the reagent enhances the selectivity for HDL cholesterol assay by complexing LDL, VLDL, and chylomicrons lipoproteins. Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems HDL Cholesterol (HDLX) Reagent SYN HDLD 510K_Summary_revised_05112010.doc 18-Dec-09 {1}------------------------------------------------ HDLX reagent is used to measure the cholesterol concentration by a timed-endpoint method. The SYNCHRON® System(s) automatically proportions the appropriate HDL cholesterol sample and reagent volumes into a cuvette. The ratio used is one part sample to 93 parts reagent. The System monitors the change in absorbance at 560 nanometers. This change in absorbance is directly proportional to the concentration of cholesterol in the sample and is used by the System to calculate and express the HDL-cholesterol concentration. #### 6.0 Intended Use: HDLX reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System(s) and Genzyme Liquid N-qeneous® HDL Cholesterol Calibrator is intended for quantitative determination of HDL Cholesterol in the high density lipoprotein fraction of human serum or plasma. Indications for Use: HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease. #### 7.0 Comparison to Predicate(s): The following table shows similarities and differences between the predicate identified in . Section 4.0 of this summary. | Predicate Device: Olympus HDL Cholesterol<br>Assay | Current device: SYNCHRON® Systems<br>HDL Cholesterol (HDLX) Reagent | |-------------------------------------------------------------------------------------|---------------------------------------------------------------------| | LIQUID stable reagents (ready to use) | same | | Intended Use | same | | Clinical Significance | same | | Fundamental Technology: chromogenic colored<br>change measured by spectrophotometer | same | | Sample Types: Serum, Plasma (Heparinized,<br>EDTA) | same | | Reference Interval | same | ### List of design inputs that are similar between the two devices ## List of design inputs that are different between the two devices | List of design inputs that are different between the two devices | | | |------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | | Predicate Device: Olympus HDL<br>Cholesterol Assay | Current device: SYNCHRON® Systems HDL<br>Cholesterol (HDLX) Reagent | | Analytical<br>Range | 2.5 - 200 mg/dL | 5 - 135 mg/dL | | Interfering<br>substances | Hemoglobin: 500 mg/dL<br>Unconjugated Bilirubin: 40 mg/dL<br>Conjugated Bilirubin: 40 mg/dL<br>Lipemia: ≤ 1500 mg/dL (Intralipid)<br>Triglyceride: ≤ 900 mg/dL (triglyceride)<br>Ascorbic Acid: 20 mg/dL<br>Immunoglobulin IgG: 5000 mg/dL | Hemoglobin: 500 mg/dL<br>Bilirubin: 30 mg/dL<br>Lipemia: ≤ 1700 mg/dL (triglyceride)<br>Ascorbic Acid: 50 mg/dL<br>Immunoglobulin IgG: 3000 mg/dL | | Sensitivity | Typical change in absorbency for 1 mg/dL<br>of HDL-Cholesterol is 1 mA | 5 mg/dL | Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems HDL Cholesterol (HDLX) Reagent SYN HDLD 510K_Summary_revised_05112010.doc 18-Dec-09 {2}------------------------------------------------ #### 8.0 Summary of Performance Data: The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments. | Candidate | Platform | Slope | Intercept | R | N | Predicate Method | |--------------------------------------------------|-------------------|-------|-----------|-------|-----|---------------------------------| | SYNCHRON<br>Systems HDL<br>Cholesterol<br>(HDLX) | UniCel DxC<br>800 | 1.06 | -4.9 | 0.991 | 100 | Olympus HDLX<br>Assay (K040692) | | SYNCHRON<br>Systems HDL<br>Cholesterol<br>(HDLX) | LX20 | 1.06 | -5.5 | 0.984 | 100 | Olympus HDLX<br>Assay (K040692) | Method Comparison Study Results SYNCHRON® Systems HDL Cholesterol (HDLX) Reagent Precision Study Results | Sample | Mean<br>(mg/dL) | S.D.<br>(mg/dL) | %C.V. | N | |----------------------------------|-----------------|-----------------|-------|----| | Within-Run Imprecision - DxC 800 | | | | | | SYN 1 | 31.82 | 0.53 | 1.66 | 20 | | SYN 2 | 46.56 | 0.39 | 0.85 | 20 | | SYN 3 | 62.33 | 0.51 | 0.82 | 20 | | Vigil Lipid 1 | 20.20 | 0.37 | 1.83 | 20 | | Vigil Lipid 2 | 57.63 | 0.65 | 1.13 | 20 | | Vigil Lipid 4 | 98.75 | 0.84 | 0.85 | 20 | | Within-Run Imprecision - LX20 | | | | | | SYN 1 | 33.13 | 0.35 | 1.05 | 20 | | SYN 2 | 47.56 | 0.37 | 0.77 | 20 | | SYN 3 | 62.61 | 0.55 | 0.87 | 20 | | Vigil Lipid 1 | 23.11 | 0.38 | 1.64 | 20 | | Vigil Lipid 2 | 58.94 | 0.78 | 1.33 | 20 | | Vigil Lipid 4 | 99.79 | 1.39 | 1.39 | 20 | This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993 Beckman Coulter, Inc. c/o Yvette Lloyd Staff Regulatory Affairs Specialist 250 S. Kraemer Blvd. Mail Stop: E2.SE.08 Brea. CA 92821 HAY 1 4 2010 Re: k100010 > Trade/Device Name: SYNCHRON® Systems HDL Cholesterol (HDLX) Reagent Regulation Number: 21 CFR 8862.1475 Regulation Name: Lipoprotein Test System Regulatory Class: Class I; meets limitations of exemptions under 21 CFR § 862.9 (c)(2) Product Code: LBS Dated: May 10, 2010 Received: May 11, 2010 Dear Yvette Lloyd: 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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). {4}------------------------------------------------ ## Page 2 If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, CA Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): k100010 Device Name: SYNCHRON® Systems HDL Cholesterol (HDLX) Reagent Indications for Use: HDLX reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System(s) and Genzyme Liquid N-geneous® HDL Cholesterol Calibrator is intended for quantitative determination of HDL Cholesterol in the high density lipoprotein fraction of human serum or plasma HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease. Prescription Use X (21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) - (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety KI000/D_ 510(k) = Page 1 of 1