SYSMEX XN SERIES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 5, 2014 Sysmex America, Inc. c/o Ms. Sharita Brooks Manager Clinical Affairs 577 Aptakisic Road Lincolnshire, IL. 60069 Re: k141681 Trade/Device Name: Sysmex® XN-Series (XN-11, XN-21) Automated Hematology Analyzers Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: October 30, 2014 Received: October 31, 2014 Dear Ms. Brooks: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical {1}------------------------------------------------ device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Maria M. Chan -S Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) k141681 Device Name XN-Series (XN-11, XN-21) Automated Hematology Analyzers Indications for Use (Describe) The XN-Series modules (XN-11, XN-21) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical and reference laboratories. The XN-Series modules classify and enumerate the following parameters in whole blood: WBC, RBC, HCT, MCV, MCH, MCHC, PLT, NEUT%H, LYMPH%#, MONO%#, E0%#, BASO%#, IG%#, RDW-SD, MPV, NRBC#/%, RET%/#, IPF, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%#, and TC-BF parameters in body fluids (peritoneal, pleural and synovial). Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. Type of Use (Select one or both, as applicable) | <input checked="" type="checkbox"/> | Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------|----------------------------------------------| | <input type="checkbox"/> | Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Submitted by: | Sysmex America, Inc.<br>577 Aptakisic Road<br>Lincolnshire, IL. 60069<br>Phone: (224) 543-9618; FAX: (224) 543-4699<br>Contact person: Sharita Brooks<br>Date prepared: June 19, 2014 | | |-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. Name of Device: | Trade or proprietary name: Sysmex® XN-Series (XN-11, XN-21)<br>Common name: Automated Hematology Analyzer<br>Classification name: Automated Differential Cell Counter 21 CFR 864.5220 is a<br>Class II device. Product Code: GKZ<br>Related Items: | | | | Product Code: 81 GIF<br>CELLPACK® DCL (Diluent) – K112605<br>CELLPACKTM DFL (Diluent) – K112065<br>CELLSHEATH(C)TM (Diluent) – K051459 | | | | Product Code: 81 GGK<br>LysercellTM WNR (Lyse) – K112605<br>LysercellTM WDF (Lyse) – K112605<br>LysercellTM WPC (Lyse) – K112605 | | | | Product Code: 81 KJK<br>FluorocellTM WNR (Stain) – K112605<br>FluorocellTM WDF (Stain) – K112605<br>FluorocellTM RET (Stain) – K112065<br>FluorocellTM PLT (Stain) – K112605<br>FluorocellTM WPC (Stain) – K112605 | | | | Product Code: 81 KSA<br>XN CAL (Calibrator) - K120745<br>XN CAL PF (Calibrator) - K120747 | | | | Product Code: 81 JPK<br>XN CHECK (Control) – K120742<br>XN CHECK BF (Control) – K120744 | | | | Analyzer Components<br>SA-10 (Auto Sampler for single module)<br>SA-20 (Auto Sampler for two modules)<br>IPU (Information Processing Unit) | | | 3. Predicate Device: | Sysmex® XE-5000Automated Hematology Analyzer | | | 4. Device Description: | The Sysmex® XN-Series modules (XN-11, XN-21) are multi-parameter hematology analyzers intended to perform tests on whole blood samples collected in K2 or K3EDTA anticoagulant and body fluids (pleural, peritoneal and synovial) collected in K2 anticoagulant. The XN-Series modules (XN-11, XN-21) are part of the family of XN-Series devices (K112605) cleared Oct 19, 2012 with modifications to stabilize the HCT/MCV parameters to within +8% at room temperature (18-26°C) for 24 hours and refrigerated temperature (2-8°C) for 48 hours for commercial and reference laboratories. The difference between the XN-11 and XN-21 is the presence of the WPC Channel in the XN-21.<br><br>The instrument consists of four principal units: (1) Two Main Units (XN-11, XN-21) which aspirate, dilute, mix, and analyze blood and body fluid samples; (2) Two Auto Sampler Units (SA-10 for a single module, or SA-20 for two modules) which supply samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system; (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit. The XN-Series analyzers perform analysis using the following methods: Sheath Flow DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. The XN-Series analyzers automatically classify cells from whole blood and body fluids and carry out all processes automatically from aspiration of the sample to outputting the results.<br><br>The body fluid analysis mode of the XN-Series analyzers uses the 4DIFF scattergram & the RBC distribution obtained from a specialized analysis sequence to calculate & display the WBC (WBC-BF) counts, mononuclear cell (MN) / polymorphonuclear cell (PMN) counts & percentages, Total Count (TC-BF) & RBC (RBC-BF) counts found in the body fluid.<br><br>Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer. | | | 5. Intended Use: | The XN-Series modules (XN-11, XN-21) are quantitative multi-parameter automated hematology analyzers intended for <i>in vitro</i> diagnostic use in screening patient populations found in clinical and reference laboratories.<br><br>The XN-Series modules classify and enumerate the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC#/%, RET%/#, IPF, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF parameters in body fluids (peritoneal, pleural and synovial). Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. | | | 6. Substantial equivalence-similarities and differences | The following table compares the XN-Series modules (XN-11, XN-21) Automated Hematology analyzers with the XE-5000 Automated Hematology analyzer. | | | 7. Clinical Performance Data: | Studies were performed to evaluate the equivalency of the XN-Series Automated Hematology analyzers (Modules XN-11, XN-21) to the XE-5000 Automated Hematology analyzer. Results indicated equivalent performance. | | | Item | Predicate XE-5000<br>(K071967)<br>20-Nov-07 | Device XN-Series<br>(XN-11, XN-21) | | Intended Use | Sysmex® XE-5000 is an automated<br>hematology analyzer for <i>in vitro</i><br>diagnostic use in screening patient<br>populations found in clinical<br>laboratories. The XE-5000 classifies<br>and enumerates the same parameters as<br>the XE-2100 using whole blood as<br>described below, cord blood for HPC<br>and has a body fluid mode for body<br>fluids. The Body Fluid mode analyzes<br>WBC-BF, RBC-BF, MN%/#, PMN%/#<br>and TC-BF in body fluids<br>(cerebrospinal fluids (CSF), serous<br>fluids, and synovial fluids with EDTA,<br>as needed).<br>WBC, RBC, HGB, HCT, MCV, MCH,<br>MCHC, PLT, NEUT% / #, LYMPH% /<br>#, ΜΟΝΟ% / #, EO% / #, BASO% / #,<br>NRBC% / #, RDW-SD, RDW-CV,<br>MPV, RET% / #, IRF, IG% / #,<br>RET-He, IPF, HPC WBC-BF,<br>RBC-BF, MN% / #, PMN%/ #,<br>TC-BF#. | The XN-Series modules (XN-11, XN-21)<br>are quantitative multi-parameter automated<br>hematology analyzers intended for <i>in vitro</i><br>diagnostic use in screening patient<br>populations found in clinical and reference<br>laboratories.<br>The XN-Series modules classify and<br>enumerate the following parameters in<br>whole blood: WBC, RBC, HGB, HCT,<br>MCV, MCH, MCHC, PLT, NEUT%/#,<br>LYMPH%/#, MONO%/#, EO%/#,<br>BASO%/#, IG%/#, RDW-CV, RDW-SD,<br>MPV, NRBC#/%, RET%/#, IPF, IRF,<br>RET-He and has a Body Fluid mode for<br>body fluids. The Body Fluid mode<br>enumerates the WBC-BF, RBC-BF,<br>MN%/#, PMN%/#, and TC-BF parameters<br>in body fluids (peritoneal, pleural and<br>synovial). Whole blood should be<br>collected in K2 or K3EDTA anticoagulant<br>and peritoneal, pleural and synovial fluids<br>in K₂EDTA anticoagulant to prevent<br>clotting of fluid. | | Equivalency Data | Proven performance in FDA<br>submission | Data consisting of Accuracy, Precision,<br>Linearity and Carryover were collected to<br>show performance to the manufacturer's<br>specification for the Whole Blood and<br>Body Fluid mode. This analysis supports<br>the claim that the XN-Series analyzers are<br>substantially equivalent to the XE-5000. | | Similarities | | | | Specimen Type | Whole Blood and Body Fluids (Serous,<br>Synovial) | SAME | | Test Principle | Performs hematology analyses<br>according to the Hydro Dynamic<br>Focusing (DC Detection), flow<br>cytometry method (using a<br>semiconductor laser), and SLS-<br>hemoglobin method. | SAME | | Parameters | <b>Whole Blood Mode:</b><br>WBC, RBC, HGB, HCT, MCV, MCH,<br>MCHC, PLT, NEUT%/#, LYMPH%/#,<br>ΜΟΝΟ%/#, ΕO%/#, BASO%/#,<br>NRBC%/#, RDW-CV, RDW-SD,<br>MPV, RET%/#, IRF, IG%/#, RET-He,<br>IPF.<br><b>Body Fluid Mode:</b><br>WBC-BF, RBC-BF, MN%/#,<br>PMN%/#, TC-BF# | SAME | | | | | | Reagents | SULFOLYSER (Lyse) | SAME | | | Sampler Analysis Mode…