SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT

{0}------------------------------------------------ K040767 # JUN = 7 2004 ### 510(k) Summary SYNCHRON® Systems HDL Cholesterol Reagent #### 1.0 Submitted By: Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4123 #### 2.0 Date Submitted: March 24, 2004 #### 3.0 Device Name(s): #### 3.1 Proprietary Names SYNCHRON® Systems HDL Cholesterol (HDLD) Reagent #### 3.2 Classification Name Lipoprotein test system (21 CFR § 862.1475) #### 4.0 Predicate Device: | Candidate(s) | Predicate | Manufacturer | Docket<br>Number | |-------------------------------------|----------------------------------|--------------------------|------------------| | SYNCHRON<br>Systems<br>HDLD Reagent | SYNCHRON Systems<br>HDLD Reagent | Beckman<br>Coulter, Inc. | K934045 | #### 5.0 Description: SYNCHRON® Systems HDL Cholesterol (HDLD) Reagent, when used in conjunction with SYNCHRON® Systems Lipid Calibrator, is intended for the quantitative determination of HDL cholesterol in the high-density lipoprotein (HDL) fraction of serum or plasma on SYNCHRON Systems. {1}------------------------------------------------ #### 6.0 Intended Use: SYNCHRON® Systems HDL Cholesterol (HDLD) Reagent, when used in conjunction with SYNCHRON® Systems Lipid Calibrator, is intended for the quantitative determination of HDL cholesterol in the high-density lipoprotein (HDL) fraction of serum or plasma on SYNCHRON Systems. ### Clinical Significance: #### 7.0 Comparison to Predicate(s): The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary. | | Similarities | | |--------------|-----------------------|--------------------------------------------------------| | HDLD Reagent | Intended Use | Same as<br>HDLC | | | Liquid stable reagent | | | | Differences | | | HDLD Reagent | Methodology | HDLC is an indirect method, HDLD is a<br>direct method | | | Analytic Range | HDLC = 5 to 90 mg/dL<br>HDLD = 5 to 135 mg/dL | #### 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 Equivalence is demonstrated through method commercial distribution. comparison, stability, linearity, and imprecision experiments. ## Method Comparison Study Results | Instrument | Slope | Intercept | r | n | Comparison Method | |-------------|-------|-----------|-------|----|-------------------| | SYNCHRON CX | 0.991 | 2.2 | 0.956 | 63 | SYNCHRON HDLC | | SYNCHRON LX | 0.973 | 0.5 | 0.972 | 66 | SYNCHRON HDLC | {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol. JUN - 7 2004 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 South Kraemer Blvd. PO Box 8000 Brea, CA 92821 Re: k040767 K040107 Trade/Device Name: SYNCHRON® Systems HDL Cholesterol (HDLD) Reagent Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBS Dated: March 24, 2004 Received: March 25, 2004 Dear Ms. Hellie: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications ferenced abo re and hansure) to legally marketed predicate devices marketed in interstate for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to eonimores 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 I ou may, ates or visions 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 it may of subject to data and 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 r loase be advisou that i Dr unation that your device complies with other requirements of the Act that I Dr has intatutes and regulations administered by other Federal agencies. You must of any I oderal batates and sequirements, 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). {3}------------------------------------------------ ### Page 2 This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and will be reading of substantial equivalence of your device to a legally premaince notifications of 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 destions on the promotion and advertising of your device, please contact the Office of or questions on the Presidention 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 rou may obtain other getarers, 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 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K0 407 (ø7 Device Name: SYNCHRON® Systems HDL Cholesterol (HDLD) Reagent Indications for Use: SYNCHRON® Systems HDL Cholesterol (HDLD) Reagent, when used in conjunction with SYNCHRON® Systems Lipid Calibrator, is intended for the quantitative determination of HDL cholesterol in the high-density lipoprotein (HDL) fraction of serum or plasma on SYNCHRON Systems. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Alberto Lutz Division Sign-Off Page 1 of **Division Sign-UP** e of In Vitro Diagnostic Device Evaluation and Sa 510(k) K040767