DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL

{0}------------------------------------------------ # DADE BEHRING DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714 ## Summary of Safety and Effectiveness This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 ## Dade Behring QuikLYTE™ MetaboLYTE Cartridge FDA Classification Name: Glucose Test System and Urea Nitrogen Test System The Dade Behring QuikLYTE™ MetaboLYTE cartridge performs two in vitro diagnostic tests: glucose (GLU7) and urea nitrogen (BUN7). Intended Use: The GLU7 and BUN7 methods on the QuikLYTE™ Module of the Dimension®XL/RxL clinical chemistry system are in vitro diagnostic tests intended for the quantitative measurement of glucose in serum, plasma and cerebrospinal fluid and of urea nitrogen in serum and plasma using Integrated Multisensor Technology (IMT). The glucose (GLU7) and urea nitrogen (BUN7) methods use a sample which is diluted automatically on-board the Dimension® XL or RxL clinical chemistry system. The diluted sample is then processed in a multisensor cartridge that uses Integrated Multisensor Technology (IMT). The glucose method uses amperometric detection and the urea nitrogen method uses potentiometric detection to measure the specific analyte in the sample. The assays performed by the Dade Behring QuikLYTE™ MetaboLYTE cartridge are substantially equivalent to the glucose (GLU) and urea nitrogen (BUN) methods packaged in FLEX™ reagent cartridges, which were cleared by the FDA through the 510(k) process. Both methodologies are processed on an automated system, the Dimension® clinical chemistry system, and are used for the determination of glucose in human serum, plasma, and cerebrospinal fluid and urea nitrogen in human serum or plasma. A split sample comparison study was conducted with the following results: | | Slope | Intercept | Correlation<br>Coefficient | Range of<br>Samples | n | |-------------------------------|-------|------------|----------------------------|---------------------|------| | Glucose<br>Serum/Plasma | 0.99 | 1.6 mg/dL | 0.998 | 20 - 415 | 239* | | Cerebrospinal Fluid | 1.05 | -1.2 mg/dL | 0.996 | 3 - 260 | 60 | | Urea Nitrogen<br>Serum/Plasma | 1.01 | -0.1 mg/dL | 0.996 | 4 - 80 | 231* | n = 239; 120 serum and 119 plasma n = 231; 118 serum and 113 plasma Lorraine H. Piestrak Lorraine H. Piestrak Quality Assurance and Compliance Manager Date: Sept 22, 1998 COUROU4 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of a bird in flight, composed of three curved lines. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle. ## DEPARTMENT OF HEALTH & HUMAN SERVICES THE 2 5 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Lorraine H. Piestrak Quality Assurance and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, Delaware 19714 Re: K983344 Trade Name: Dade Bchring QuikLYTE™ MetaboL YTE Cartridge Regulatory Class: II Product Codc: CGA, CDN Dated: April 12, 1999 Received: April 13, 1999 Dear Ms. Piestrak: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be lound in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response 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 Flectronic Product Radiation Control provisions, or other Federal laws or regulations. {2}------------------------------------------------ ### Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLA-88), this device may require a CLIA complexity categorization. To determing if it descrean best in and and Chiled Laboratory Improvement Amendments of 1988 (CLA-88), this device require a CLIA complexity categorization. To determine if it does, you should contact the 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 notification. The FDA finding of substantial equivalence of vour device to al notification. " and on your marketing your device as described in your device to a legally market predication. The FDA finding of substantial equivalence of your device to a results in a classification for your device and thus, your device to a legally many 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 antest the Off addition of opsome advice of your device on our labeling regulation (21 CFR Pat 801 and (301) 594-4588. Additionally, for questioneric devices), please ontact the office of (201) 2017-09-13 101 mg diagnostic devices), please on the Office of Compliance of Compliance of Complimited of Complimited of Compliune of Compliune and Compluderice, plance of Continued on the promotion and advertision and advertision of your care entitle des are of Complance at (30 ) 594-4639. Also, please mont regulation, and other of your device, entitle "Misbranding by reference to premacit notification"(21 Other information on your responsibilities under the Act may be obted to the legulation information on your responsibilities under the Act may be obted to the Division of Small at the see your responsibilities under the Act may be obtained from the Division of Shiston of Shiston of Shiston of Shinan internet address "http://www.fda.gov/cdrb/dsmadsma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sincerely yours, Steven Autman 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 {3}------------------------------------------------ ## Indications Statement Device Name: Dade Behring QuikLYTE™ MetaboLYTE cartridge Indications for Use: The Dade Behring QuikLYTE™ MetaboLYTE cartridge is a sub-system on The Dade Bentling QuikETTE - Meadeous andyzer. It performs two in die Differences indications for use indications for use: #### Glucose යුග්‍යය Measurements are used in the difficial and al hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. #### Urea Nitrogen a Nitrogen Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. Jean Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K-983344 Loucene H. Pestiak Lorraine H. Piestrak Quality Assurance and Compliance Manager Sept 22, 1998 Date (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) K983344 0(k) Number Oram Crozier Division Sign-Offi Office of Device Evaluation prescription use Image /page/3/Picture/18 description: The image shows a series of numbers, specifically six zeros followed by a six, arranged in a row. Below this row of numbers, there is a second row of what appears to be a series of curved lines or arcs. The overall image has a somewhat grainy or textured appearance, possibly due to the quality of the image capture or the original source material. \