LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642

{0}------------------------------------------------ K012513 Page 1 of 2 # AUG 2 9 2001 Summary of Safety and Effectiveness ## Liquichek™ Lipids Control #### Submitter 1.0 Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1555 Fax: ### Contact Person Maria Zeballos Requlatory Affairs Specialist Telephone: (949) 598-1367 ## Date of Summary Preparation August 3, 2001 #### Device Identification 2.0 | Product Trade Name: | Liquichek™ Lipids Control | |---------------------|-------------------------------------------------| | Common Name: | Multi-Analyte Controls, (Assayed and unassayed) | | Classifications: | Class I | | Product Code: | 75JJT | CFR 862.1660 Regulation Number: #### 3.0 Device to Which Substantial Equivalence is Claimed Liquichek™ Lipids Control Bio-Rad Laboratories Irvine, California Docket Number: K002460 #### 4.0 Description of Device Liquichek™ Lipids Control is prepared from human serum with added constituents of human and animal origin, pure chemicals preservatives and stabilizers. The control is provided in liquid form for convenience. #### 5.0 Statement of Intended Use Liquichek™ Lipids Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures listed in the package insert. {1}------------------------------------------------ #### Comparison of the new device with the Predicate Device 6.0 The new Liquichek™ Lipids Control claims substantial equivalence to the Liquichek™ Lipids Control currently in commercial distribution (K002460). The new Liquichek™ Lipids Control contains C-reactive Protein (CRP) and the current product does not. | Table 1. Similarities and Differences between new and predicate device | | | |------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristics | Bio Rad<br>Liquichek™ Lipids Control<br>(New Device) | Bio Rad<br>Liquichek™ Lipids Control<br>(Predicate Device) | | Similarities | | | | Intended Use | Liquichek™ Lipids Control is intended for<br>use as an assayed quality control serum<br>to monitor the precision of laboratory<br>testing procedures for the analytes listed<br>in the package insert. | Liquichek™ Lipids Control is intended for<br>use as an assayed quality control serum<br>to monitor the precision of laboratory<br>testing procedures for the analytes listed<br>in the package insert. | | Form | Liquid | Liquid | | Matrix | Human serum based | Human serum based | | Storage<br>(Unopened) | -10 °C to -20°C<br>until expiration date | -10 °C to -20°C<br>until expiration date | | Storage<br>(Thawed and unopened) | 14 days at 2-8°C | 14 days at 2-8°C | | Open Vial Claim | 14 days at 2-8°C | 14 days at 2-8°C | | Differences | | | | Analytes | Similar analytes as the predicate device<br>with the additional claims for CRP | Does not contain CRP. | Table 1. Similarities and Differences between new and predicate device #### Summary of Performance Data 7.0 Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Lipids Control. Product claims are as follows: - Thawed and unopened vial: Once the control material is thawed and the vial is 7.1 unopened all analytes will be stable for 14 days at 2-8°C. - Open vial: Once the control material is thawed and opened, all analytes will be 7.2 stable for 14 days when stored tightly capped at 2-8℃. - Shelf Life: 36 months when stored at -10 to -20 °C 7.3 Real time studies will be ongoing to support the shelf life of this product. All supporting data is retained on file at Bio-Rad Laboratories. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. AUG 2 9 2001 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Elizabeth Platt Regulatory Affairs Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618 Re: K012513 Trade/Device Name: Liquichek Lipids Control Regulation Number: 21 CFR 862.1660 Regulatory Class: I, reserved Product Code: JJY Dated: August 3, 2001 Received: August 6, 2001 Dear Ms. Platt: 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. 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. {3}------------------------------------------------ Page 2 - 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 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) 59 + 15 cl (1 c office 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 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, Steven Butman 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}------------------------------------------------ 510 (k) Number (if known): Hol2513 Device Name: Liquichek™ Lipids Control Indications for Use: Assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert (PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) 1 Prescription use Over-the Counter use__________________________________________________________________________________________________________________________________________________________ _ or 510(k) Number