LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK

{0}------------------------------------------------ # Summary of Safety and Effectiveness ## Liquichek Immunoassay Plus Control OCT 17 2012 #### 1.0 Submitter Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1557 Fax: ## Contact Person Suzanne Parsons Regulatory Affairs Manager Telephone: (949) 598-1467 ## Date of Summary Preparation October 16, 2012 #### 2.0 Device Identification | Product Trade Name: | Liquichek Immunoassay Plus Control | |---------------------|---------------------------------------------| | Common Name: | Multi-Analyte Controls, All Kinds (Assayed) | | Classifications: | Class I | | Product Code: | JJY | | Regulation Number: | 21 CFR 862.1660 | #### Device to Which Substantial Equivalence is Claimed 3.0 Liquichek Immunoassay Plus Control Bio-Rad Laboratories Irvine, California 510 (k) Number: K001373 #### 4.0 Description of Device Liquichek Immunoassay Plus Control is prepared from human serum with added constituents of human and animal origin, chemicals, therapeutic drugs, stabilizers and preservatives. 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 non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2. This product may also contain other human source material for which there are no approved tests. {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 Immunoassay Plus Control is intended for use as an assayed quality control serum 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 Liguichek Immunoassay Plus Control claims substantial equivalence to the Liquichek Immunoassay Plus Control currently in commercial distribution (K001373). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed. | Characteristics | Liquichek Immunoassay Plus Control<br>(New Device) | Liquichek Immunoassay Plus Control<br>(Predicate Device, K001373) | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Similarities | | | | Intended Use | Liquichek Immunoassay Plus Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert. | Liquichek Immunoassay Plus Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert. | | Matrix | Human Serum | Human Serum | | Form | Liquid | Liquid | | Differences | | | | Fill Volume | Level 1, 2 and 3 - 12 x 2.5 mL<br>Trilevel MiniPak - 3 x 2.5 mL | Level 1, 2 and 3- 12 x 5 mL<br>Trilevel MiniPak - 3 x 10 mL | | Thawed Opened<br>Stability | 4 days at 2 to 8°C | 14 days at 2°C to 8 °C<br>Except Folate: 4 days at 2 to 8°C<br>Estradiol: 5 days at 2 to 8°C | | Thawed<br>Unopened<br>Stability | 4 days at 2 to 8°C | 30 days at 2 to 8°C<br>Except Folate: 4 days at 2 to 8°C<br>Estradiol: 8 days at 2 to 8°C<br>Free PSA, PSA, Prolactin: 14 days at 2 to 8°C | | Storage unopened<br>(Shelf life) | -20°C to -50°C until expiration date | -20°C to -70°C until expiration date | Table 1. Similarities and Differences between new and predicate device. {2}------------------------------------------------ Bio-Rad Laboratories Premarket Notification Section 510 (k) Liquichek Immunoassay Plus Control | Analytes | Contains: | | Contains: | | |----------|-----------------------------------------------|-------------------------------------|--------------------------------------------------|----------------------------------------| | | Acetaminophen | Lithium | 17-Alpha<br>Hydroxyprogesterone | Imipramine | | | Alpha Fetoprotein | N-Acetylprocainamide | 11-Deoxycortisol | Insulin | | | Amikacin | Phenobarbital | 25-Hydroxy Vitamin D | Iron | | | Caffeine | Phenytoin | Acetaminophen | Luteinizing Hormone | | | Carbamazepine | Procainamide | Alpha Fetoprotein | Lidocaine | | | Carcinoembryonic Antigen | Prolactin | Aldosterone | Lithium | | | CK-MB Isoenzyme | Prostate Specific Antigen | Amikacin | N-Acetylprocainamide | | | Digoxin | Prostate Specific<br>Antigen, Free | Amiodarone | Netilmicin | | | Estradiol | Salicylate | Amitriptyline | Nortriptyline | | | Ferritin | T3, Free | Androstenedione | Prostatic Acid<br>Phosphatase | | | Folate | T3, Total | Angiotensin I | Phenobarbital | | | Follicle Stimulating Hormone | T3 Uptake/T Uptake | Antithyroid Peroxidase<br>Antibodies | Phenytoin | | | Gentamicin | T4, Free | Antithyroglobulin<br>antibody | Phenytoin, Free | | | Human Chorionic Gonadotropin<br>-Beta Subunit | T4, Total | Caffeine | Primidone | | | Immunoglobulin A | Theophylline | Carbamazepine | Procainamide | | | Immunoglobulin E | Tobramycin | Carbamazepine, Free | Progesterone | | | Immunoglobulin G | Thyroid Stimulating<br>Hormone | Carcinoembryonic<br>Antigen | Prolactin | | | Immunoglobulin M | Valproic Acid | Chloramphenicol | Propanolol | | | Iron | Vancomycin | CK-MB Isoenzyme | Prostate Specific<br>Antigen | | | Luteinizing Hormone | Vitamin B12 | Cortisol | Prostatic Specific<br>Antigen, Free | | | Lidocaine | | Cyclosporine | Parathyroid<br>Hormone - MM | | | | | Desipramine | Quinidine | | | Does not Contain: | | Dehydroepiandrosterone | Salicylate | | | 17-Alpha Hydroxyprogesterone | Human Growth Hormone | Dehydroepiandrosterone<br>Sulfate | Sex Hormone<br>Binding Globulin | | | 11-Deoxycortisol | Ibuprofen | Digoxin | Somatomedin-C | | | 25-Hydroxy Vitamin D | Imipramine | Disopyramide | T3, Free | | | Aldosterone | Insulin | Estradiol | T3, Total | | | Amiodarone | Netilmicin | Estriol, Free | T3 Uptake/T Uptake | | | Amitriptyline | Nortriptyline | Estrogen, Total | T4, Free | | | Androstenedione | Prostatic Acid<br>Phosphatase | Ethosuximide | T4, Total | | | Angiotensin I | Phenytoin, Free | Estriol, Total | Thyroxine Binding<br>Globulin | | | Antithyroid Peroxidase<br>Antibodies | Primidone | Ferritin | Testosterone | | | Antithyroglobulin antibody | Progesterone | Flecainide | Testosterone, Free | | | Carbamazepine, Free | Propanolol | Folate | Theophylline | | | Chloramphenicol | Parathyroid Hormone -<br>MM | Follicle Stimulating<br>Hormone | Tobramycin | | | Cortisol | Quinidine | Fructosamine | Total Iron Binding<br>Capacity | | | Cyclosporine | Sex Hormone Binding.<br>Globulin | Gentamicin | Thyroid Stimulating<br>Hormone | | | Desipramine | Somatomedin-C | Human Chorionic<br>Gonadotropin | Tricyclic<br>Antidepressants<br>Screen | | | Dehydroepiandrosterone | Thyroxine Binding<br>Globulin | Human Chorionic<br>Gonadotropin -Beta<br>Subunit | Thyroglobulin | | | Dehydroepiandrosterone Sulfate | Testosterone | Human Growth Hormone | Valproic Acid | | | Disopyramide | Testosterone, Free | Ibuprofen | Valproic Acid, Free | | | Estriol, Free | Total Iron Binding<br>Capacity | Immunoglobulin A | Vancomycin | | | Estriol, Total | Tricyclic Antidepressants<br>Screen | Immunoglobulin E | Vitamin B12 | | | Estrogen, Total | Thyroglobulin | Immunoglobulin G | | | | Ethosuximide | Valproic Acid, Free | Immunoglobulin M | | | | Flecainide | | | | | | Fructosamine | | | | | | Human Chorionic Gonadotropin | | | | #### Statement of Supporting Data 8.0 Stability studies have been performed for Liquichek Immunoassay Plus Control to determine following claims: Thawed Opened Stability: 4 days at 2 to 8°C 4 days at 2 to 8°C. Thawed Unopened Stability: Shelf Life Stability: 28 Months at -20°C to -50°C The acceptance criteria for above studies is defined as the recovery result on final day (TFna) being ± 10% of the recovery result of freshly opened vial (Tzero). {3}------------------------------------------------ . #### 9.0 Conclusion Liquichek Immunoassay Plus Control is intended to be used for the same purpose as the predicate device. It has human serum matrix and performs similarly as the predicate device. All supporting data is retained on file at Bio-Rad Laboratories. 1 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {4}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, with human profiles incorporated into the design. 10903 New Hampshire Avenue Silver Spring, MD 20993 Bio-Rad Laboratories c/o Suzanne Parsons 9500 Jeronimo Road Irvine, CA 92618-2017 k122838 Re: > Trade Name: Liquichek Immunoassay Plus Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJY Dated: September 13, 2012 Received: September 17, 2012 Dear 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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). OCT 17 2012 {5}------------------------------------------------ ## Page 2 If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Devices 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 postmarket surveillance, please contact CDRH'S Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-576-. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical Devices/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) 796-5680 or at its Internet address http://www.fda/gov/MedicalDevices/ResourcesforYou/Industry/default.htm Sincerely yours, / Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use Form 510(k) Number (if known): k122838 Device Name: Liquichek Immunoassay Plus control Indications for Use: Liquichek Immunoassay Plus 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. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Rutd Clu Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 122838 510(K)