COULTER CELLPREP

{0}------------------------------------------------ # JUN 1 1 2002 K021150 # Summary of Safety & Effectiveness COULTER® CellPrep # 1.0 Submitted By: Lourdes Coba Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: (305) 380-4079 FAX: (305) 380-3618 # 2.0 Date Submitted: April 9, 2002 ### 3.0 Device Name(s): # 3.1 Proprietary Names COULTER® CellPrep ## 3.2 Classification Name Automated blood cell diluting apparatus (21 CFR § 864.5240) ### 4.0 Predicate Device: | Candidate(s) | Predicate | Manufacturer | Docket Number | |-------------------|-----------------------|-----------------------|---------------| | COULTER® CellPrep | COULTER® Multi-Q-Prep | Beckman Coulter, Inc. | K923530 | # 5.0 Description: The COULTER® CellPrep is a compact, fully automated sample processing workstation which can be programmed to perform a variety of cell wash, dilution, and concentration operations. {1}------------------------------------------------ # 6.0 Intended Use: The COULTER® CellPrep is an automated system that processes human blood for preparation of leukocyte suspensions for quantitative immunofluorescence analysis by optical flow cytometers. The use of data generated by this instrument depends on the requlatory status of the reagents you use. If the reagent is labeled by the manufacturer "For Research Use Only. Not for use in diagnostic procedures," federal law prohibits the use of the data for diagnosis. This product is intended "For In Vitro Diagnostic Use" when using the "IVDImmunophenotype" protocol and processing whole blood samples with COULTER reagents and antibodies labeled for In Vitro Diagnostic Use. # Clinical Significance: Separation of cells with a phenotypic low antigen density from cells with no phenotypic specificity can be modulated by a simple removal of background fluorescence such as plasma, media, excess tagged antibody, and fluorescent drug compounds. Removal of these components increases the fluorescent separation of positive and negative cells. # 7.0 Comparison to Predicate(s): COULTER® CellPrep is similar to the COULTER® Multi-Q-Prep. ### 8.0 Summary of Performance Data: The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution. This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. JUN 11 2002 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. Lourdes Coba Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 S.W. 147 Avenue M/S 31-B06 Miami, Florida 33196-2500 Re: k021150 > Trade/Device Name: COULTER® CellPrep Regulation Number: 21 CFR § 864.5240 Regulation Name: Automated blood cell diluting apparatus Regulatory Class: I Product Code: GKH Dated: April 9, 2002 Received: April 10, 2002 Dear Mr. Coba: 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 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); 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. {3}------------------------------------------------ Page 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, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 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 {4}------------------------------------------------ of 510(k) Number (if known): COULTER® CellPrep Device Name: Indications for Use: The COULTER® CellPrep is an automated system that processes human blood for preparation of leukocyte suspensions for quantitative immunofluorescence analysis by optical flow cytometers. The use of data generated by this instrument depends on the regulatory status of the reagents you use. If the reagent is labeled by the manufacturer "For Research Use Only. Not for use in diagnostic procedures," federal law prohibits the use of the data for diagnosis. This product is intended "For In Vitro Diagnostic Use" when using the "IVDImmunophenotype" protocol and processing whole blood samples with COULTER reagents and antibodies labeled for In Vitro Diagnostic Use. 864.5240 Automated blood cell diluting apparatus Identification. An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V (per 21 CFR 801.109) OR Over-the-Counter Use Optional Format 1-2-96 Josephine Bautista ion of Clinical Laborato 510(k) Number Beckman Coulter, Inc., Section 510(k) Notification CellPrep CellPrep Section1 040902.doc