LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK

{0}------------------------------------------------ 123775 Bio-Rad Laboratories Premarket Notification Section 510 (k) Liguichek Spinal Fluid Control 510(k) Summary Page 1 of 3 ## 510(k) Summary Liquichek Spinal Fluid Control #### 1.0 Submitter JAN 3. 1 2013 Bio-Rad Laboratories 9500 Jeronimo Road. Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1557 ## Contact Person Suzanne Parsons Regulatory Affairs Manager Telephone: (949) 598-1467 ### Date of Summary Preparation January 28, 2013 #### 2.0 Device Identification | Product Trade Name: | Liquichek Spinal Fluid Control | |---------------------|----------------------------------------------------| | Common Name: | Multi-Analyte Controls, All Kinds (Assayed) | | Review Panel: | Clinical Chemistry and Clinical Toxicology Devices | | Classifications: | Class I, Reserved | | Product Code: | JJY | | Regulation Number: | 21 CFR 862.1660 | #### 3.0 Device to Which Substantial Equivalence is Claimed Liquichek Spinal Fluid Control Bio-Rad Laboratories Irvine, California 510 (k) Number: K990888 #### 4.0 Description of Device Liquichek Spinal Fluid Control is a human based control with added constituents of human and animal origin, chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience. Each human donor unit used to manufacture this control was tested by FDA accepted methods and found to be non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2. | Level | Catalog Number | Configuration | |-----------------|----------------|--------------------------| | Level 1 | 303 | 6 x 2.5 mL | | Level 2 | 304 | 6 x 2.5 mL | | Bilevel MiniPak | 302X | 2 x 2.5 (1 per level) mL | Table 1: Product Catalog Description {1}------------------------------------------------ #### 5.0 Value Assignment The mean values and the corresponding ±3SD ranges printed in this insert were derived from replicate analyses and are specific for this lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides. Laboratory established ranges may vary from those listed during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications. #### 6.0 Intended Use Liquichek Splnal Fluid Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in this package insert. #### 7.0 Comparison of the new device with the Predicate Device The new Liquichek Spinal Fluid Control claims substantial equivalence to the Liquichek Spinal Fluid Control currently in commercial distribution (K990888). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed. | Characteristics | Liquichek Spinal Fluid Control<br>(New Device) | Liquichek Spinal Fluid Control<br>(Predicate Device, K990888) | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Similarities | | | Intended Use | Liquichek Spinal Fluid Control is Intended for use<br>as an assayed quality control material to monitor<br>the precision of laboratory testing procedures for<br>the analytes listed in the package insert. | Liquichek Spinal Fluid Control is intended for use<br>as an assayed quality control material to monitor<br>the precision of laboratory testing procedures for<br>the analytes listed in the package insert. | | Form | Liquid | Liquid | | Matrix | Diluted Human serum | Diluted Human serum | | Storage Unopened<br>(Shelf life) | At 2 - 8 °C until the expiration date | At 2 - 8 °C until the expiration date | | Differences | | | | Fill Volume | 2.5 mL | 3 mL | | Open Vial Stability | 30 days at 2 - 8 °C on board Siemens Dimension<br>Vista instrument | 30 days at 2 - 8 °C | | Analytes | Contains:<br>Albumin<br>Chloride<br>Glucose<br>Immunoglobulin G (IgG)<br>Lactate(Lactic Acid)<br>Lactate Dehydrogenase (LDH)<br>Protein Total<br>Sodium<br>Does not contain:<br>Immunoglobulin M (IgM)<br>Globulin ( $\alpha_1$ , $\alpha_2$ , β, γ)<br>Immunoglobulin A (IgA) | Contains:<br>Albumin<br>Chloride<br>Glucose<br>Immunoglobulin G (IgG)<br>Lactate(Lactic Acid)<br>Lactate Dehydrogenase (LDH)<br>Protein Total<br>Sodium<br>Immunoglobulin M (IgM)<br>Globulin ( $\alpha_1$ , $\alpha_2$ , β, γ)<br>Immunoglobulin A (IgA) | Table 1: Simllarlies and Differences between the new and predicate device {2}------------------------------------------------ #### 8.0 Statement of Supporting Data Stability studies have been performed and acceptance criteria were met for Liquichek Spinal Fluid Control to determine the stability claims. Product claims are as follows: | Open Vial: | 30 days at 2 to 8°C | |-----------------------|---------------------| | Shelf Life Stability: | 2 Years at 2 to 8°C | #### 9.0 Conclusion s Based on the performance characteristics indicated above, Bio-Rad's Liquichek Spinal Fluid Control is substantially equivalent to the predicate device K990888. All supporting data Is retained on file at Bio-Rad Laboratories. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUM AN SERVICES Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an image of a stylized eagle. ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G Silver Spring, MD 20993-002 ## January 31, 2013 Bio-Rad Laboratories c/o Suzanne Parsons 9500 Jeronimo Road Irvine, CA 92618-2017 Re: k123775 Trade/Device Name: Liquichek Spinal Fluid Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material Regulatory Class: Class I, Reserved Product Code: JJY Dated: December 6, 2012 Received: December 10, 2012 Dear Ms. Suzanne Parsons: 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 -- Suzanne Parsons If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, ## Carol C. Benson Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health for Enclosure {5}------------------------------------------------ ## Indications for Use Form 510(k) Number (if known): k123775 Device Name: Liquichek Spinal Fluid Control Indications for Use: Liquichek Spinal Fluid Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in this package insert. The following analytes are listed in the package insert: - > Albumin - > Chloride - > Glucose - > Immunoglobulin G (IgG) - Lactate (Lactic Acid) A Lactate Dehydrogenase (LDH) A > Protein Total > Sodium | Prescription Use | X | |-----------------------------|---| | (21 CFR Part 801 Subpart D) | | | And/Or | | | Over the Counter Use | | | (21 CFR Part 801 Subpart C) | | (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) # Yung W/. Chan -S Division Sign-Off Office of In Vitro Diagnostics and Radiological Health (OIR) 510(k)_k123775