SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747

{0}------------------------------------------------ # SEP 16 2004 K 042195 ### 510(k) Summary SYNCHRON® Systems HDL Cholesterol Reagent and Lipid Plus Calibrators 1 & 2 #### 1.0 Submitted By: Kim Walker Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-4912 FAX: (714) 961-4123 ### 2.0 Date Submitted: August 11, 2004 #### 3.0 Device Name(s): #### 3.1 Proprietary Names SYNCHRON® Systems HDL Cholesterol (HDL) Reagent SYNCHRON® Systems Lipid Plus Calibrators 1 & 2 #### 3.2 Classification Name Lipoprotein test system (21 CFR § 862.1475) Calibrator, Primary (21 CFR § 862.1150) #### 4.0 Predicate Devices: | Candidate(s) | Predicate | Manufacturer | Docket<br>Number | |------------------------------------------------------|------------------------------------------|--------------------------|------------------| | SYNCHRON<br>Systems<br>HDL Reagent | SYNCHRON<br>Systems<br>HDLD Reagent | Beckman<br>Coulter, Inc. | K040767 | | SYNCHRON®<br>Systems Lipid Plus<br>Calibrators 1 & 2 | SYNCHRON®<br>Systems Lipid<br>Calibrator | Beckman<br>Coulter, Inc. | K983640 | Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON HDL Cholesterol (HDL) Reagent SYN_HDL510K_Section1.doc, August 2004 {1}------------------------------------------------ ### Description: 5.0 ### Reagent The SYNCHRON LX® and CX® CE/DELTA/PRO System(s) HDL reagent is designed for optimal performance on the SYNCHRON LX® and CX® CE/DELTA/PRO System(s). The reagent kit contains two 200-test cartridges that are packaged separately from the associated calibrators. ### Calibrator The SYNCHRON® Systems Lipid Plus Calibrator set is a two level readyto-use human serum-based liquid calibrator set manufactured by Beckman Coulter, Inc. Each kit contains 1 X 3 mL bottles of each level of calibrator (identified as Level 1 and Level 2). ### 6.0 Intended Use: ## Reagent HDL reagent, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma. HDL reagent, when used in conjunction with SYNCHRON CX® CE/DELTA/PRO System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma. ## Calibrator The SYNCHRON Systems Lipid Plus Calibrators 1& 2, in conjunction with specified assays on the SYNCHRON® Systems, are intended to provide points of reference in the measurement of selected human lipids and proteins. ### 7.0 Comparison to Predicate(s): The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary. {2}------------------------------------------------ ## Similarities to the Predicate | Reagent | Aspect/Characteristic | Comments | |--------------------------|--------------------------------------|-------------------------------------------------| | HDL<br>Reagent | Intended Use | Same as Beckman<br>SYNCHRON HDLD<br>Reagent | | | Liquid Stable Reagent | | | | Analytical Range | | | | Sample Type | | | | Reference Intervals | | | | Shelf Life Stability | | | Lipid Plus<br>Calibrator | Liquid Stable Calibrator | Same as Beckman<br>SYNCHRON Lipid<br>Calibrator | | | Value Assignment Methodology | | | | Storage Temperature (-15°C to -20°C) | | | | Levels of Analyte (2 levels) | | # Differences From The Predicate | Reagent | Aspect/Characteristic | Comments | |--------------------------|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | HDL<br>Reagent | Sample Size | HDLD is 3 $\mu$ l, HDL is 4 $\mu$ l | | | Methodology | HDLD uses solubilization polyanion; HDL uses a<br>cholesterol oxidase acceleration and dissolving<br>of HDL by use of a specific detergent. | | | Reactive<br>Ingredients | HDL added Ascorbic oxidase, removed the<br>Polyanion and increased the detergent<br>concentration. | | | Interferences | HDLD Ascorbic acid 50 mg/dL; HDL 100 mg/dL<br>HDLD IgG 3000 mg/dL; HDL 5000 mg/dL | | Lipid Plus<br>Calibrator | Intended Use | The SYNCHRON® Systems Lipid Calibrator is<br>intended for use with the SYNCHRON Systems<br>for the calibration of direct HDL Cholesterol<br>reagent.<br><br>SYNCHRON Systems Lipid Plus Calibrators 1 &<br>2 are stabilized liquid calibrators designed for<br>use with SYNCHRON® Systems for the<br>calibration of Lipids and Proteins. | | | Shelf Life Stability | Lipid Calibrator is stable up to 18 months; Lipid<br>Plus Calibrator is stable up to 24 months | | | Source Material | Lipid Calibrator contains defibrinated human<br>plasma spiked with human lipids; Lipid Plus<br>Calibrator is human serum based and contains<br>endogenous levels of HDL | {3}------------------------------------------------ #### Summary of Performance Data: 8.0 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. | Instrument | Slope | Intercept | r | n | Comparison Method | |-------------|-------|-----------|-------|----|-------------------| | SYNCHRON CX | 0.992 | -2.8 | 0.994 | 79 | SYNCHRON HDLD | | SYNCHRON LX | 1.000 | -2.8 | 0.993 | 79 | SYNCHRON HDLD | Method Comparison Study Results ### SYNCHRON CX System HDL Reagent Imprecision Results | Sample | Mean<br>(mg/dL) | S.D.<br>(mg/dL) | %C.V. | N | |------------------------|-----------------|-----------------|-------|----| | Within-Run Imprecision | | | | | | Level 1 | 28.0 | 0.5 | 1.6 | 80 | | Level 2 | 57.6 | 0.9 | 1.5 | 80 | | Level 3 | 76.3 | 2.1 | 2.8 | 80 | | Total Imprecision | | | | | | Level 1 | 28.0 | 1.4 | 5.1 | 80 | | Level 2 | 57.6 | 1.4 | 2.4 | 80 | | Level 3 | 76.3 | 2.6 | 3.4 | 80 | ### SYNCHRON LX System HDL Reagent Imprecision Results | Sample | Mean<br>(mg/dL) | S.D.<br>(mg/dL) | %C.V. | N | |------------------------|-----------------|-----------------|-------|----| | Within-Run Imprecision | | | | | | Level 1 | 27.6 | 0.3 | 1.2 | 80 | | Level 2 | 56.0 | 0.8 | 1.5 | 80 | | Level 3 | 72.7 | 1.7 | 2.3 | 80 | | Total Imprecision | | | | | | Level 1 | 27.6 | 1.7 | 6.1 | 80 | | Level 2 | 56.0 | 1.6 | 2.9 | 80 | | Level 3 | 72.7 | 1.9 | 2.6 | 80 | 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. Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON HDL Cholesterol (HDL) Reagent SYN_HDL510K_Section1.doc, August 2004 {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (U.S.A.). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three parallel lines that curve and overlap, resembling a stylized representation of a human form or a medical symbol. Public Health Service SEP 1 6 2004 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Kim Walker Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000 Re: k042195 Trade/Device Name: SYNCHRON® Systems HDL Cholesterol (HDL) Reagent SYNCHRON® Systems Lipid Plus Calibrators 1&2 Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, LBS Dated: August 11, 2004 Received: August 13, 2004 Dear Ms. Walker: 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). {5}------------------------------------------------ ### 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, Jean M. Cooper, MS, DVM. Jean 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 {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): K042195 Device Name: SYNCHRON® Systems HDL Cholesterol (HDL) Reagent SYNCHRON® Systems Lipid Plus Calibrators 1 & 2 Indications for Use: Reagent: HDL reagent, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma. HDL reagent, when used in conjunction with SYNCHRON CX® CE/DELTA/PRO System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma. Calibrator: The SYNCHRON® Systems Lipid Plus Calibrator 1& 2, in conjunction with specified assays on the SYNCHRON® Systems, are intended to provide points of reference in the measurement of selected human lipids and proteins. ﺴﺎ Over-The-Counter Use Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Qffice of In Vitro Diagnostic Devices (OIVD) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of ____________________________________________________________________________________________________________________________________________________________________ 510(k) K042195 Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON HDL Cholesterol (HDL) Reagent SYN HDL510K Section1.doc, August 2004