CELL-DYN SAPPHIRE SYSTEM

{0}------------------------------------------------ JUL 2 1 2005 | 510(k) Summary | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act 1990 and 21 CFR 807.92. | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The assigned 510(k) number is: <span style="text-decoration: underline;">K051215</span> | | | CELL-DYN Sapphire™ System | | Submitted by | Abbott Laboratories<br>5440 Patrick Henry Drive<br>Santa Clara, CA 95054 | | Contact Person | Michelle Roeding<br>Phone (408) 567-3781 Fax (408) 982-4863 | | Date Prepared | May 10, 2005 | | Proprietary Name | CELL-DYN Sapphire™ System | | Common Name | Automated Hematology Analyzer | | Classification Name | Automated Differential Cell Counter (21 CFR 864.5220) | | Predicate Device | Abbott CELL-DYN 4000 System | | Device Description | The CELL-DYN Sapphire System is a benchtop analyzer consisting of the main analyzer with data station, flat panel display, printer, and associated reagents. The data station, display, and printer are stand-alone modules. The system has the capability to sample either from closed collection tubes via the autoloader, or from open collection tubes through the aspiration probe in the Open Tube mode. | ... . ..... {1}------------------------------------------------ | Intended Use | | The CELL-DYN Sapphire System is a multiparameter,<br>automated hematology analyzer designed for in vitro<br>diagnostic use in clinical laboratories.<br><br>The CELL-DYN Sapphire System has the same intended use<br>as previously cleared for the CELL-DYN 4000 System<br>(predicate device). | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Similarities<br>And<br>Differences | | The CELL-DYN Sapphire System and the CELL-DYN 4000<br>System are similar in that: | | | a) | Both systems provide quantitation of the hemogram and<br>automated WBC differential parameters in EDTA-<br>anticoagulated human whole blood specimens. | | | b) | Both systems will accept specimens presented automatically by<br>the autoloader or manually presented by the operator. | | | c) | Both systems utilize multiple measurement methodologies:<br>impedance, laser optical scatter, fluorescence, and optical<br>absorbance methods. | | | d) | Both systems measure RBC and PLT by laser optical scatter<br>and focused-flow impedance with injection metering. | | | e) | Both systems measure WBC by laser optical scatter and<br>fluorescence. | | | f) | Both systems use fluorescence to enumerate reticulocytes,<br>NRBC, CD61, and CD3/4/8. | | | g) | Both systems provide Dispersional Data Alerts, Suspect<br>Parameter Messages, and Suspect Population Flags to assist in<br>data review. | | | h) | Both systems accept input from keyboard and send data output<br>to: video screen, hard drive, and printer; and both systems<br>provide RS232 Interface to an on-line LIS as well as using<br>microprocessors for systems control, data acquisition, and data<br>analysis. | | | | The CELL-DYN Sapphire System and the CELL-DYN 4000<br>System are different in that: | | | a) | The CELL-DYN Sapphire System uses a solid state laser to<br>facilitate both optical scatter and fluorescence measurements | | b) | The CELL-DYN Sapphire System uses a Unix based Linux<br>operating system, while the CELL-DYN 4000 uses a Unix<br>based Lynx operating system. | | | c) | The CELL-DYN Sapphire System has the ability to download<br>raw list mode data (FCS type) to media for analysis, while the<br>CELL-DYN 4000 System does not have this capability. | | | d) | The CELL-DYN Sapphire System has internal pneumatic<br>components, while the CELL-DYN 4000 has a separate<br>external pneumatic unit. | | | Medical - Clinical<br>Study Protocol | The Medical - Clinical Study Protocols for the CELL-DYN<br>Sapphire are found in Attachment E. | | | Equivalency<br>Data Summary | The CELL-DYN Sapphire System is a multiparameter,<br>automated hematology analyzer designed for in vitro<br>diagnostic use in clinical laboratories. The CELL-DYN<br>Sapphire System, which includes reagents and software, was<br>compared in clinical trials to the CELL-DYN 4000 System.<br>The data compiled supports the claim that the CELL-DYN<br>Sapphire System is substantially equivalent to the CELL-DYN<br>4000 System and includes data for background, carryover,<br>comparability (correlation), imprecision (reproducibility),<br>analytical measurement range (linearity), and sensitivity and<br>specificity. The data supporting the claim that the<br>CELL-DYN Sapphire is substantially equivalent to the<br>CELL-DYN 4000 is found in Attachment G. | | | Conclusion | The CELL-DYN Sapphire System is substantially equivalent to<br>the CELL-DYN 4000 (predicate device). The differences<br>noted do not pose new questions of safety and effectiveness. | | while the CELL-DYN 4000 uses an Argon-ion laser. : {2}------------------------------------------------ {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its wing, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Druq Administration 2098 Gaither Road Rockville MD 20850 Ms. Michelle Roeding Section Manager, Regulatory Affairs Abbott Laboratories 5440 Patrick Henry Drive . . . . . . JE E & 2005 JUL 2 1 2005 Hematology Business Unit Santa Clara, CA 95054 = Re: k051215 Trade/Device Name: CELL- DYN Sapphire™ System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: May 10, 2004 Received: May 12, 2004 Dear Ms. Rocding: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bection o re(a) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to regardy the Medical Device Amendments, or to conninered pror to May 20, 2019, 11:25 eccordance with the provisions of the Federal Food, Drug, de necs that have been rout do not require approval of a premarket approval application (PMA). and Cosment Act (710c) that the novice, subject to the general controls provisions of the Act. The r ou may, diererors, mains of the Act include requirements for annual registration, listing of general controls proving 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 your de subject to such additional controls. Existing major regulations affecting your device n may oc subject it outer also a and 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 or uny I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as bet form in keting your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonicate device results in a classification for your device and thus, permits your device to proceed to the market. {4}------------------------------------------------ Page 2 - If you desire specific information about the application of labeling requirements to your device, If you destro species and advertising of your device, please contact the Office of In or questions on the proce Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (24€PR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain 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/industry/support/index.html Sincerely vours, lobatz Beckerh Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use Statement 510(k) Number (if known): **K** 510(k) Number (if known): K05/215 . ... . . . . . Device Name: CELL-DYN Sapphire™ System ﺘﺸﻐﻴﻨﺎﺕ ﺑﺘﺤﻘ Indications for Use: The CELL-DYN Sapphire System is a multiparameter, automated hematology analyzer designed to provide complete blood count with WBC Differential, NRBC, Reticulocyte and Immature Reticulocyte Fraction enumeration, and CD61 and CD3/4/8 immunofluorescent analysis on EDTA-anticoagulated whole blood. (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use<br>(Per 21 CFR 801.109) | X | |------------------------------------------|--------------------------------------------------| | | OR | | | Over-The-Counter Use<br>(Optional Format 1-2-96) | Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety | 510(k) | K051215 | |--------|---------| |--------|---------| 005CELL-DYN Sapphire™ System Traditional 510(k) Submission