LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596

{0}------------------------------------------------ ## Summary of Safety and Effectiveness Liguichek™ Immunology Control ### 1.0 Submitter SEP 1 7 2002 Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1555 Fax: ## Contact Person Maria Zeballos Regulatory Affairs Specialist Telephone: ## Date of Summary Preparation September 2, 2002 ### 2.0 Device Identification | Product Trade Name: | Liquichek™ Immunology Control | |---------------------|-------------------------------------------------| | Common Name: | Multi-Analyte Controls, (Assayed and unassayed) | | Classifications: | Class I | | Product Code: | 75JJY | | Regulation Number: | CFR 862.1660 | ### 3.0 Device to Which Substantial Equivalence is Claimed Liquichek™ Immunology Control Bio-Rad Laboratories Irvine, California Docket Number: K011494 #### 4.0 Description of Device Liquichek™ Immunology Control is prepared from human serum with added serum proteins, constituents of animal origin, preservatives and stabilizers. The control is provided in liquid form for convenience. {1}------------------------------------------------ ## 5.0 Statement of Intended Use Liquichek™ Immunology Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in this package insert. ## Comparison of the new device with the Predicate Device 6.0 The new Liquichek™ Immunology Control claims substantial equivalence to the Liquichek™ Immunology Control currently in commercial distribution (K011494). The new Liquichek™ Immunology Control contains ADNase B, C1-Inhibitor, Cystatin-C, IgG subclasses, Lp (a) and the current product does not. | | Bio Rad | Bio Rad | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristics | LiquichekTM Immunology Control<br>(New Device) | LiquichekTM Immunology Control<br>(Predicate Device) | | Similarities | | | | Intended Use | LiquichekTM Immunology Control is<br>intended for use as an assayed quality<br>control serum to monitor the precision of<br>laboratory testing procedures for<br>analytes listed in this package insert. | LiquichekTM Immunology Control is<br>intended for use as an assayed quality<br>control serum to monitor the precision of<br>laboratory testing procedures for analytes<br>listed in this package insert. | | Form | Liquid | Liquid | | Matrix | Human serum based | Human serum based | | Storage<br>(Unopened Frozen) | -10 °C to -20°C<br>until expiration date | -10 °C to -20°C<br>until expiration date | | Storage<br>(Unopened Thawed) | 90 days at 2-8° C | 90 days at 2-8° C | | Open Vial Claim | 30 days at 2-8° C with the following<br>exception: Rheumatoid Factor is stable<br>for 21 days at 2 to 8°C | 30 days at 2-8° C with the following<br>exception: Rheumatoid Factor is stable for<br>21 days at 2 to 8°C | | Differences | | | | | Same analytes as the predicate device<br>with the additional claims for ADNase B,<br>C1-Inhibitor, Cystatin-C, IgG subclasses,<br>and Lp (a). | ADNase B, C1-Inhibitor, Cystatin-C, IgG<br>subclasses, and Lp (a) are not included. | Table 1. Similarities and Differences between new and predicate device. ## 7.0 Summary of Performance Data Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Immunology Control. Product claims are as follows: - 7.1 Open vial: Once the product is thawed and opened, all analytes will be stable for 30 days when stored tightly capped at 2 to 8°C with the exception of Rheumatoid Factor, which will be stable for 21 days. {2}------------------------------------------------ - 7.2 Closed Vial: Once thawed and stored unopened at 2 to 8°C, all analytes will be stable for 90 days. - 7.3 Shelf Life: Two years when stored at -- 10 to -- 20 °C. 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. {3}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Maria Zeballos Regulatory Affairs Specialist Bio-Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017 SEP 1 7 2002 Rc: k022991 > Trade/Device Name: Liquichek™M Immunology Control Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I Product Code: JJY Dated: September 6, 2002 Received: September 9, 2002 Dear Ms. Zeballos: 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ 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 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" (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 Sutman 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 {5}------------------------------------------------ . 510 (k) Number (if known): K022991 Device Name: Liquichek™ Immunology Control Indications for Use: An assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert. (PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription use or Over-the Counter use Deborah M. Moore