LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is a black rectangle with rounded corners, and the words "BIO-RAD" are written in white, bold letters inside the rectangle. The letters are slightly slanted to the right, and the overall design is simple and modern. Bio-Rad Laboratories California 92618 K99 2550 # 510(k) Summary Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (949)598-1555 Contact Person Elizabeth Platt Date of Summary Preparation May 3, 1999 Device (Trade & Common Name) Liquichek Immunology Control Classification Name Class 1, 75JJY CFR 862.1660: Multi-Analyte Control, All Kinds (Assayed and Unassayed) Devices to Which Substantial Equivalence is Claimed Liquichek Immunology Control Bio-Rad Laboratories Irvine, California K945651/A004 ### Statement of Intended Use Olatement of intended for use as an assayed quality control serum Elquionon inimationy of laboratory testing procedures for the analytes listed in the package insert. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that develops, manufactures, and markets a broad range of products and services to the life science research and clinical diagnostics markets. The logo is in a black rounded rectangle with the words "BIO-RAD" in white letters. The letters are bold and sans-serif. Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200 # Description of the Device Description of the Device Liquichek Immunology Control is prepared from human serum with added serum ing in the Immunology Control is prepared from for convenience Liquichek Immunology Control is prepared from haman bearn for convenience. proteins and stabilizers. The control is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative. # Statement of How Technological Characteristics Compare to Substantial Equivalence Device A table is provided below comparing the similarities between the Bio-Rad Liquichek A table is provided below companing the similance between is claimed. Immunology Control and the devices to which substantial equivalence is claimed. Immunology Control and t | | Bio-Rad Liquichek Immunology<br>Control (New Device) | Bio-Rad Immunology Control<br>(Substantially Equivalent Device) | |--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Intended<br>Use | An assayed quality control serum to<br>monitor the precision of laboratory<br>testing procedures for the analytes<br>listed in the package insert. | An assayed quality control serum to<br>monitor the precision of laboratory<br>testing procedures for the analytes<br>listed in the package insert. | | Form | Liquid | Liquid | | Matrix | Human serum based | Human serum based | | Storage | 2-8°C | 2-8°C | | Open Vial<br>Claim | 90 days when thawed and stored<br>unopened at 2-8°C; 30 days when<br>opened and stored tightly capped at<br>2-8°C. | 90 days when thawed and stored<br>unopened at 2-8°C; 30 days when<br>opened and stored tightly capped at<br>2-8℃. | | Analytes | Same analytes as the substantially<br>equivalent device; refer to proposed<br>product insert. | Refer to attached substantially<br>equivalent device product insert. | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. # DEPARTMENT OF HEALTH & HUMAN SERVICES AUG 11 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvinc, California 92618-2017 K992550 Re: K992530 Trade Name: Liquichek Immunology Control Regulatory Class: I Product Code: JJY Dated: July 29, 1999 Received: July 30, 1999 Dear Ms. Platt: Deal new reviewed your Section 510(k) notification of intent to market the device referenced. The have reviewed the device is cubstantially equivalent (for the indications fo We have reviewed your Section 510(k) notification of thient in our of the indications for use above and we have and well meedsted predicated predicate devices marketed in int above and we have determined the device is substantially equivalent (over the marketed in interstate commerce s and we no more of the markmant deta of the Medical Devices mar stated in the enclosure) to legally markets in the Medical Device Amendments, or to devices that prior to May 28, 1976, the enactment date of the Federal Food, Dug, and prior to May 28, 1976, the enatment and on the Federal Food, Drug, and have been reclassified in accordance with the provisions of the reast controls Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosmetic Act (Act). You may, therefore, market the Act include requirements for annual provisions of the Act. The general controls provisions of the Act include requirents provisions of the Act. The general controls provisions of the Heerines of the Prohibitions against registration, listing of devices, good manufacturing practice, labeling, a misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III n report of the success of the states of instite work additional controls. Exist If your device is classified (see abded) into ender class in (opentials . Existing major regulations. (Premarket Approval), it may be subject to such additions Title 21, Par (Premarket Approval), it may be sibject to such auch as money on the 21, Parts 800 to 895. affecting your device can be found in the Code of Federal Regulations with the Curr attecting your device can be found in this ossumes compliance with the Current Good A substantially equivalent determination the Ouclity System Regulation (C A substantially equivalent decemblacion asset forthe Quality System Regulation (QS) for Manufacturing Practice requirements, as set for the Quality System Regulation (OS) Manufacturing Practice requirements, as set reart 820) and that, through penodic QS Medical Devices: General regulation (21 CFR Part of a wife such accurations Medical Devices: General regulation (21 OFR Parvensy such assumptions. Failure to inspections, the Food and Drug Administration (FDA) will ver EDA may watch inspections, the rood and Drug Aummondation (orgulatory action. In addition, PDA may publish comply with the GMT regaration may rodevice in the Federal Register. Please note: this further alliouncements concerning your submission does not affect any obligation you might response to your premarket nothleads 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 Under the Chilical Laboratory Interestion. To determine if it does, you should contact the require a CETA comproxity Sangeres 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 I his letter will allow you to ocgin marketing your device to a legally marketed to notification. The PDA inding of substantial equivalians 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 additionally 809.10 for mi vitto diagnostions on the promotion and advertising of your device, (201) 594-4568. Additionally, for questions of (301) 594-4639. Also, please note the regulation presse contact the Office of Comphalled (21 CFR 807.97). The grand of Science of Small information on your responsibilities under the Act may be obtained from the Division of Small mioritiation on your responsionness and imber (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 {4}------------------------------------------------ Page 1 of 1 510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Device Name: Liquichek Immunology Control Indications for Use: Liquichek immunology Control is intended for use as an 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) | (Division Sign-Off) | | |-----------------------------------------|---------| | Division of Clinical Laboratory Devices | | | 510(k) Number | K992550 | | Prescription Use | <div style="display:inline-block; vertical-align:middle;">✓</div> | OR Over-The Counter Use | _________________ | |------------------|-------------------------------------------------------------------|-------------------------|-------------------| |------------------|-------------------------------------------------------------------|-------------------------|-------------------|