LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800

{0}------------------------------------------------ Bio-Rad Laboratories Premarket Notification Section 510(k) for Liquid Assayed Multiqual Control Summary of Safety and Effectiveness KOII867 Page 1 of 3 # Summary of Safety and Effectiveness Liquid Assayed Multiqual® Control Levels 1, 2 and 3 #### 1.0 Submitter Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1555 Fax: ## Contact Person Ofelia Cachola Regulatory Affairs Specialist Telephone: (949) 598-1287 # Date of Summary Preparation June 8, 2001 #### 2.0 Device Identification Liquid Assayed Multiqual® Control Levels 1, 2 and 3 Product Trade Name: Multi-Analyte Controls, (Assayed and unassayed) Common Name: Classifications: Class I 75JJY Product Code: CFR 862.1660 Regulation Number: #### 3.0 Device to Which Substantial Equivalence is Claimed MULTIQUAL® ASY I, II, III Ciba Corning Diagnostics Corp. (Bio-Rad Laboratories) Irvine, California Docket Number: K923633 #### 4.0 Description of Device Liquid Assayed Multiqual® Control is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin) chemicals, drugs, preservatives and stabilizers have been added. The control is provided in liquid form for convenience. {1}------------------------------------------------ ### Statement of Intended Use 5.0 Liquid Assayed Multiqual® Control is intended for use as an assayed quality Elquia Aseayou manifar the precision of laboratory testing procedures for analytes listed in the package insert. ### Comparison of the new device with the Predicate Device 6.0 The new Liquid Assayed Multiqual® Control claims substantial equivalence to the MULTIQUAL ASY I, II, III (K923633). | | Bio Rad | Bio Rad | |----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristics | Liquid Assayed Multiqual® Control<br>Levels 1, 2 and 3<br>(New Device) | Liquid Assayed Multiqual® Control<br>Levels 1, 2 and 3<br>(Predicate Device) | | <b>Similarities</b> | | | | Intended Use | Liquid Assayed Multiqual® Control is<br>intended for use as an assayed quality<br>control serum to monitor the precision of<br>laboratory testing procedures for the<br>analytes listed in the package insert. | Use Multiqual® quality control material,<br>assayed, to monitor the precision and the<br>accuracy of general chemistry,<br>immunochemistry, and therapeutic drug<br>monitoring test procedures. | | Form | Liquid | Liquid | | Matrix | Human serum based | Human serum based | | Storage<br>(Unopened Frozen) | -20°C or colder<br>until expiration date | Below -10 °C<br>until expiration date | | Storage<br>(Unopened Thawed) | 2-8° C<br>30 days with the following exceptions:<br>Total bilirubin values may decrease.<br>Alkaline phosphatase activity may rise.<br>The control must be stored frozen when<br>using AST methods without pyridoxal-5-<br>phosphate. | 2-8° C<br>30 days with the following exceptions:<br>Total bilirubin values may decrease.<br>Alkaline phosphatase activity may rise.<br>The control must be stored frozen when<br>using AST methods without pyridoxal-5-<br>phosphate. | | <b>Differences</b> | | | | Open, Vial<br>Claim | 2-8° C for 14 days with the following<br>exceptions: Total bilirubin will be stable<br>for 10 days and LAP Arylamidase will be<br>stable for 3 days. | 2-8° C for 14 days with the following<br>exceptions: Total bilirubin will be stable for<br>10 days. | | Analytes | Same analytes as the predicate device<br>with additional claims for the following:<br>Acetaminophen, Alpha-1-Antitrypsin,<br>Amikacin, Amylase (Pancreatic),<br>Apolipoprotein A, Apolipoprotein B, C3<br>Complement, C4 Complement,<br>Ceruloplasmin, Cholesterol-LDL, CK-MB<br>Isoenzyme, Copper, Globulin, | Refer to the substantially equivalent<br>product insert. | | Haptoglobin, Immunoglobulins (IgA, IgG,<br>IgM), LAP-Arylamidase, Prealbumin,<br>Prostatic Acid Phosphatase, Protein<br>Electrophoresis and Transferrin. | | | | | | | Table 1. Similarities and Differences between new and predicate device. 06_SSE_Mult_9816_6/0 {2}------------------------------------------------ ### Summary of Performance Data 7.0 Stability studies have been performed to determine the open vial stability and shelf life for the Liquid Assayed Multiqual® Control. Product claims are as follows: - Open vial: Once the control material is thawed and opened, all analytes 7.1 . will be stable for 14 days when stored tightly capped at 2-8℃ with the following exceptions: Total bilirubin will be stable for 10 days and LAP Arvlamidase will be stable for 3 days. Avoid repeated freezing and thawing of the quality control material. - Closed vial: When the control material is thawed and stored unopened at 7.2 2-8°C, all analytes will be stable for 30 days with the following exceptions: Total bilirubin values may decrease; alkaline Phosphatase activity may rise. The control must be stored frozen when using AST methods without pyridoxal-5-phosphate. - Shelf life: Three years when stored at -20°C or colder. For optimum 7.3 performance, avoid storage in a frost-free freezer. Store vials away from the light. 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 is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three overlapping wing shapes, suggesting movement or flight. The text is arranged so that "DEPARTMENT OF HEALTH & HUMAN SERVICES" is on the left side of the circle, and "USA" is on the right side. ງປະ 1 2 2001 Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Donna Chapman Quality Assurance/Regulatory Affairs Manager Bio Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618-2017 Re: 510(k) Number: K011867 STO(R) Name: Liquid Assayed Multiqual® Control Levels 1, 2, and 3 Regulation Number: 862.1660 Regulatory Class: I, reserved Product Code: JJY Dated: June 8, 2001 Received: June 14, 2001 Dear Ms. Chapman: We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your books, be device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device microute conmistor proc to has been reclassified in accordance with the provisions of the Amendinoms, of to devices and in t (Act). You may, therefore, market the device, subject to I coord i ood, Drug, and Coomistic Fre Act. The general controls provisions of the Act include the general connois provisions of and isting 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 (1 remance ripproval), it may of success the Code of Federal Regulations, Title 21, Parts 800 to 895. atiount four as novelvalent determination assumes compliance with the Good Manufacturing A substantially oqurvalences and (GMP) regulation (21 CFR Part 820) and that, through I ractive for Mourself ons, the Food and Drug Administration (FDA) will verify such periodic GMP inspocals.comply with the GMP regulation may result in regulatory action. In assumptions: Transity to compty with in the mouncements concerning your device in the Federal adultion, I Dri may publish caranse 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 any obtigation you mighting Control provisions, or other Federal laws or regulations. {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your 510(k) prematket This letter will allow you to begin marketing our device of your device to a legally marketed notification. The FDA finding of substantial equivals and thus, neemits your de notification. The FDA inding of substantar equiration of 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 CFF Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at additionally 809.10 for in vitro diagnostic devices), please contact the office of additionally 809.10 for in Vito diaguosic as nothe promotion and advertising of your device, (301) 594-4588. Additionally, for questions of (301) 594-4639. Also, please note the regulation please contact the Office of Compliation at (301) 37 Teation" (21CFR 807.97). Other general entitled, "Misbranding by telefence to plemanter the Act may be obtained from the Division of Small information on your responsibilities under the Act (201) M3, 6597 or st it information on your responsibilities miser (800) 638-2041 or (301) 443-6597 or at its Manufacturers Assistance at its toll-free humansing transman tran't Manufacturers Assistance at ta ton areas - 12 ton = 7 / 4 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 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 {5}------------------------------------------------ 510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________ Liquid Assayed Multiqual® Control Levels 1, 2 and 3 Device Name: Indications for Use: An assayed quality control serum to monitor the precision of laboratory the first and the control to the diving his neekege insort An assayed quality outdres for analytes listed in the package insert. Sean Cooper (Division Sign-Off) y Devices Division of Clinical Laborator ﺎ ﺍ 510(k) Number (Please DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) or Prescription use_ Over-the Counter use_