QBC CENTRIFUGAL HEMATOLOGY CONTROL

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a logo for R&D Systems. The logo features the letters "R" and "D" in a bold, sans-serif font, with an ampersand (&) symbol placed between them. Below the letters, the word "SYSTEMS" is written in a smaller, sans-serif font. The logo appears to be in black and white. DEC 1 0 1998 ## Special 510(k) Summary OBC® Centrifugal Hematology Control Date of Summary: Company Name: Contact name: Classification name: Classification code: Product name: CFR section: Device Class: November 16, 1998 R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Kenneth T. Edds. Ph.D. 612-379-2956, FAX 612-379-6580 multiparameter hematology control 81JPK Hematology Control mixtures for Quality Control QBC® Centrifugal Hematology Control 864.8625 Class II Device to which substantial equivalence is claimed: OBC® Centrifugal Hematology Control, manufactured by R&D Systems, Inc. and currently being sold by Becton Dickinson Primary Care Diagnostics, Sparks, MD. 510(k) number: K954137 The product is an in vitro diagnostic reagent composed of mammalian erythrocytes, mammalian leukocytes and simulated platelets in a plasma-like fluid with preservatives. OBC Control is composed of stable materials that provide a means of monitoring the performance of QBC centrifugal hematology systems. Overall system performance of disposable OBC blood tubes, including tube coating and float, is also monitored. QBC control is available in two levels that have varying concentrations of the parameters measured. QBC Control is used and tested in the same manner as patient samples. Intended use: OBC Centrifugal Hematology Control is intended as a quality control for OBC+. OBC II. OBC II Plus, QBC Reference and QBC AUTOREAD centrifugal hematology systems, to monitor hematocrit, hemoglobin, white blood cell count, granulocyte count, lymphocyte/monocyte count, and platelet count. QBC® Centrifugal Hematology Control has an intended use that is similar to the predicate device. The technologies of the two devices are similar. Nonclinical testing of 3 validation lots centered on the performance attributes of stability and precision. QBC® Centrifugal Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. QBC® Centrifugal Hematology Control also demonstrated precision as indicated by the small standard deviations and %CVs obtained during testing. Improved platelet performance was also noted. Expiration dating has been established at 21 days in the customers hands (closed vial) and 8 days open vial when stored at 2-8°C and handled according to instructions for use. R & D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 PHONE: (612) 379-2956 FAX: (612) 379-6580 WATS: (800) 343-7475 E-MAIL: info@rndsystems.com {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread. Public Health Service DEC 1 0 1998 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Kenneth T. Edds, Ph.D. Requlatory Affairs R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, Minnesota 55413 Re : K984099 Trade Name: QBC® Centrifuqal Hematology Control Regulatory Class: II Product Code: JPK November 16, 1998 Dated: Received: November 17, 1998 Dear Dr. Edds: 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 leqally 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, Druq, 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {2}------------------------------------------------ Paqe 2 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 your device to a legally marketed predicate device results in a classification for 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 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbrandinq by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Putman 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}------------------------------------------------ 510(k) Number: K984099 Device Name:QBC Centrifugal Hematology Control Indications for Use: QBC Centrifugal Hematology Control is intended as a quality control for QBC+, QBC II, QBC II Plus, QBC Reference and QBC AUTOREAD centrifugal hematology systems, to monitor hematocrit, hemoglobin, white blood cell count, granulocyte count, lymphocyte/monocyte count, and platelet count. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |-----------------------------------------|---------| | Division of Clinical Laboratory Devices | | | 510(k) Number | K984099 | | Prescription Use | <div>✓</div> | OR | Over-The-CounterUse | |------------------|--------------|----|---------------------| |------------------|--------------|----|---------------------| (Optional Format 1-2-96)