VIGIL LIPID CONTROL

{0} Beckman Instruments, Inc., Section 510(k) Notification VIGIL Lipid Controls Summary of Safety & Effectiveness K974452 DEC 17 1997 # Summary of Safety & Effectiveness ## Beckman VIGIL™ Lipid Controls ### 1.0 Submitted By: Richard T. Ross Staff Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-4912 FAX: (714) 961-4541 ### 2.0 Date Submitted: 21 November 1997 ### 3.0 Device Name(s): #### 3.1 Proprietary Names VIGIL™ Lipid Control #### 3.2 Classification Name Quality Control Material (assayed and unassayed) (21 CFR § 862.1660) ### 4.0 Predicate Device(s): | BECKMAN Reagent | Predicate | Predicate Company | Docket Number | | --- | --- | --- | --- | | VIGIL™ Lipid Controls | VIGIL PR_{x}^{TM} Controls | Beckman Instruments, Inc. | K936184 | ### 5.0 Description: The VIGIL™ Lipid Controls are four level ready-to-use human serum-based liquid controls manufactured by Beckman Instruments, Inc. Each kit contains 4 X 4 mL bottles of a single level of control. ### 6.0 Intended Use: Beckman's Vigil Lipid Control is intended for use in monitoring the reliability of automated in vitro diagnostic assays of total cholesterol, HDL cholesterol (HDLc), triglycerides, apolipoprotein A-1 and apolipoprotein B in the clinical laboratory. The use of three or more levels of control allows the laboratorian to monitor change in calibration linearity along with analytical error and imprecision. file: Lipid_510k.sse {1} Beckman Instruments, Inc., Section 510(k) Notification VIGIL Lipid Controls Summary of Safety & Effectiveness # 7.0 Comparison to Predicate(s): The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary. ## SIMILARITIES to the PREDICATE | Reagent | Aspect/Characteristic | Comments | | --- | --- | --- | | Vigil Lipid Control | Intended use | Same as the predicate | | | Value Assignment | Same process as the predicate | | | Storage Temperature | Same as predicate at -15 °C to -20°C | ## DIFFERENCES from the PREDICATE | Reagent | Aspect/Characteristic | Comments | | --- | --- | --- | | Vigil Lipid Control | Formulation | Vigil Lipid: stabilized by storage at -15°C to -20°C Vigil PR_{s}: stabilized with ethylene glycol and storage at -15°C to -20°C | | | Levels of analyte | Vigil Lipid: 4 levels Vigil PR_{s}: 3 levels | | | Analytes | Vigil Lipid: Contains: cholesterol, HDL cholesterol, triglycerides, apolipoprotein A-1 and apolipoprotein B fortified to attain various levels. Vigil PR_{s}. Contains: apolipoprotein A-1, apolipoprotein B and endogenous cholesterol, HDL cholesterol and triglycerides. | # 8.0 Summary of Performance Data: The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence of the Vigil Lipid Controls to the Vigil PRs. Stress stability studies of the Vigil Lipid Controls support the Beckman stability claim of 24 months. ## Vigil Lipid Controls Shelf Life Stability Study Summary | Stress Temperature | Duration of Incubation | Beckman Stability Claim* | | --- | --- | --- | | 25°C | 42 Days | 24 months | | 32°C | 45 Days | 24 months | | 37°C | 27 Days | 24 months | | 41°C | 20 Days | 24 months | *Expiration dating placed on the package based on date of manufacture 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. file: Lipid_510k.sse {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 17 1997 Richard T. Ross Staff Regulatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Boulevard, M/S W-104 P.O. Box 8000 Brea, California 92822-8000 Re: K974452 VIGIL™ Lipid Controls Regulatory Class: I Product Code: JJY Dated: November 21, 1997 Received: November 25, 1997 Dear Mr. Ross: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3} Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 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, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, 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 {4} K974452 page ___ of ___ 510(k) Number (if known): Not yet assigned Device Name: VIGIL™ Lipid Control Indications for Use: Beckman's Vigil Lipid Control is intended for use in monitoring the reliability of automated in vitro diagnostic assays of total cholesterol, HDL cholesterol (HDLc), triglycerides, apolipoprotein A-1 and apolipoprotein B in the clinical laboratory. The use of three or more levels of control allows the laboratorian to monitor change in calibration linearity along with analytical error and imprecision. ## 21 CFR 862.1660 Quality Control Material (assayed and unassayed) (a) Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency studies in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls. (b) Classification. Class I. (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 (Division Sign-Off) Division of Control Laboratory Devices 510(k) Number 12974452 Over-the-Counter Use Optional Format 1-2-96