SYSMEX XN-SERIES

K112605 · Sysmex America, Inc. · GKZ · Oct 19, 2012 · Hematology

Device Facts

• Record ID: K112605
• Device Name: SYSMEX XN-SERIES
• Applicant: Sysmex America, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Oct 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. 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 cerebrospinal fluid (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and, Serous and Synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.

Device Story

Sysmex XN-Series (XN-10, XN-20) are multi-parameter automated hematology analyzers; process whole blood (K2/K3EDTA) and body fluids (CSF, serous, synovial). System components: Main Units (aspiration/analysis), Auto Sampler Units, Information Processing Unit (IPU), Pneumatic Unit. Methods: RF/DC detection, sheath flow DC, flow cytometry (semiconductor laser), SLS-hemoglobin. Particle identification via forward scatter, fluorescence, and adaptive cluster analysis. Analyzers automate sample mixing, aspiration, and analysis. Results displayed on IPU; transmittable to host computers. Used in clinical laboratories by trained personnel. Provides quantitative cell counts and differentials; aids in screening and clinical decision-making. Includes rules-based rerun/reflex capabilities. Benefits: automated high-throughput analysis, standardized flagging for abnormal morphology, and expanded body fluid analysis capabilities.

Clinical Evidence

Bench testing only. Studies evaluated accuracy, precision, linearity, and carryover for the Body Fluid mode to demonstrate performance against manufacturer specifications and equivalence to the XE-5000 predicate.

Technological Characteristics

Multi-parameter hematology analyzer; uses RF/DC detection, sheath flow DC, and semiconductor laser flow cytometry. SLS-hemoglobin method. Connectivity: IPU supports multi-module integration. Software: Rules-based rerun/reflex logic. Sterilization: N/A (in vitro diagnostic). Form factor: Modular (XN-10/XN-20 units, auto-samplers, conveyors).

Indications for Use

Indicated for in vitro diagnostic screening of patient populations in clinical laboratories. Analyzes whole blood (K2/K3EDTA) and body fluids (CSF, serous, synovial).

Regulatory Classification

Identification

An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”

Predicate Devices

• Sysmex® XE-5000 Automated Hematology Analyzer (k071967)

Submission Summary (Full Text)

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# 5. 510(k) 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. The assigned 510(k) number is: K112605

| 1. Submitted by: | Sysmex America, Inc.<br>One Nelson C. White Parkway<br>Mundelein, IL. 60060<br>Phone: [phone]; FAX: [phone]<br>Contact person: Sharita Brooks<br>Date prepared: August 31, 2011 |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device: | Trade or proprietary name: Sysmex® XN-Series (XN-10, XN-20)<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><b>Related Items:</b><br>Product Code: 81GIF<br>CELLPACKTM DCL (Diluent)<br>CELLPACKTM DFL (Diluent)<br>Product Code: 81GGK<br>LYSERCELL WNR (Lyse)<br>LYSERCELL WDF (Lyse)<br>LYSERCELL WPC (Lyse)<br>Product Code: 81KJK<br>FLUOROCELL WNR (Stain)<br>FLUOROCELL WDF (Stain)<br>FLUOROCELL RET (Stain)<br>FLUOROCELL PLT (Stain)<br>FLUOROCELL WPC (Stain)<br>Product Code: 81KSA<br>XN CAL (Calibrator)<br>XN CAL PF (Calibrator)<br>Product Code: 81JPK<br>XN-Check (Control)<br>XN-Check BF (Control)<br>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-10, XN-20) are multi-parameter hematology<br>analyzers intended to perform tests on whole blood samples collected in K₂ or<br>K₃EDTA and body fluids (pleural, peritoneal and synovial) collected in K₂<br>anticoagulant. It can also perform tests on CSF which should not be collected in any<br>anticoagulant. The instrument consists of four principal units: (1) Two Main Units<br>(XN-10, XN-20) which aspirate, dilute, mix, and analyze blood and body fluid<br>samples; (2) Two Auto Sampler Units (SA-10, SA-20) which supply samples to the<br>Main Unit automatically; (3) IPU (Information Processing Unit) which processes<br>data from the Main Unit and provides the operator interface with the system; (4)<br>Pneumatic Unit which supplies pressure and vacuum from the Main Unit. The XN-<br>Series analyzers perform analysis using the following methods: RF/DC Detection<br>Method, Sheath Flow DC Detection Method, and Flow Cytometry Methods using a<br>Semiconductor Laser. Particle characterization and identification is based on<br>detection of forward scatter, fluorescence and adaptive cluster analysis. The XN-<br>Series analyzers automatically classify cells from whole blood and body fluids and<br>carry out all processes automatically from aspiration of the sample to outputting the<br>results.<br><br>The body fluid analysis mode of the XN-Series analyzers uses the 4DIFF<br>scattergram & the RBC distribution obtained from a specialized analysis sequence to<br>calculate & display the WBC (WBC-BF) counts, mononuclear cell (MN) /<br>polymorphonuclear cell (PMN) counts & percentages, TC-BF (Total Count) & RBC<br>(RBC-BF) counts found in the body fluid. |
| | 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-10, XN-20) are quantitative multi-parameter<br>automated hematology analyzers intended for <i>in vitro</i> diagnostic use in screening<br>patient populations found in clinical laboratories. |
| | The XN-Series modules classify and enumerate the following parameters in whole<br>blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F),<br>NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV,<br>RDW-SD, MPV, NRBC#/%, RET%/#, IPF, IRF, RET-He and has a Body Fluid<br>mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF,<br>MN%/#, PMN%/#, and TC-BF parameters in cerebrospinal fluid (CSF), serous<br>fluids (peritoneal, pleural) and synovial fluids. Whole blood should be collected in<br>K₂ or K₃EDTA anticoagulant and, Serous and Synovial fluids in K₂EDTA<br>anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF<br>specimens is neither required nor recommended. |
| 6. Substantial equivalence-<br>similarities and differences | The following table compares the XN-Series modules (XN-10, XN-20) Automated<br>Hematology analyzers with the XE-5000 Automated Hematology analyzer. |
| 7. Clinical Performance<br>Data: | Studies were performed to evaluate the equivalency of the XN-Series Automated<br>Hematology analyzers (Modules XN-10, XN-20) to the XE-5000 Automated<br>Hematology analyzer. Results indicated equivalent performance. |

Sysmex XN-Series modules (XN-10, XN-20) Automated Hematology Analyzers 510(k) Submission OCT 1 9 2012

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Sysmex XN-Series modules (XN-10, XN-20)
Automated Hematology Analyzers 510(k) Submission

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Table 1: Substantial Equivalence – Similarities and Differences to the XN-Series Automated Hematology analyzers (Modules XN-10, XN-20) and XE-5000 Automated Hematology analyzer.

| Features<br>(Submission #) | Predicate XE-5000<br>(K071967) | XN-Series<br>(XN-10, XN-20) | |
|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Clearance | 20-Nov-07 | | |
| Intended Use | XE-5000 | XN-10 | XN-20 |
| | Sysmex® XE-5000 is an | The Sysmex® XN-10 | The Sysmex® XN-20 module is |
| | automated hematology | module is a quantitative | a quantitative multi-parameter |
| | analyzer for in vitro | multi-parameter automated | automated hematology analyzer |
| | diagnostic use in screening | hematology analyzer | intended for in vitro diagnostic |
| | patient populations found in | intended for in vitro | use in screening patient |
| | clinical laboratories. The | diagnostic use in screening | populations found in clinical |
| | XE-5000 classifies and | patient populations found in | laboratories. The XN-Series |
| | enumerates the same | clinical laboratories. The | modules classify and enumerate |
| | parameters as the XE-2100 | XN-Series modules classify | the following parameters in |
| | using whole blood as<br>described below, cord blood | and enumerate the following<br>parameters in whole blood: | whole blood: WBC, RBC,<br>HGB, HCT, MCV, MCH, |
| | for HPC and has a body fluid | WBC, RBC, HGB, HCT, | MCHC, PLT (PLT-I, PLT-F), |
| | mode for body fluids. The | MCV, MCH, MCHC, PLT | NEUT%/#, LYMPH%/#, |
| | Body Fluid mode analyzes | (PLT-I, PLT-F), NEUT%/#, | MONO%/#, EO%/#, |
| | WBC-BF, RBC-BF, | LYMPH%/#, MONO%/#, | BASO%/#, IG%/#, RDW-CV, |
| | MN%/#, PMN%/# and TC- | EO%/#, BASO%/#, IG%/#, | RDW-SD, MPV, NRBC#/%, |
| | BF in body fluids | RDW-CV, RDW-SD, MPV, | RET%/#, IPF, IRF, RET-He |
| | (cerebrospinal fluids (CSF), | NRBC#/%, RET%/#, IPF, | and has a Body Fluid mode for |
| | serous fluids, and synovial | IRF, RET-He and has a Body | body fluids. The Body Fluid |
| | fluids with EDTA, as | Fluid mode for body fluids. | mode enumerates the WBC-BF. |
| | needed). | The Body Fluid mode | RBC-BF, MN%/#, PMN%/#, |
| | WBC, RBC, HGB, HCT, | enumerates the WBC-BF, | and TC-BF parameters in |
| | MCV, MCH, MCHC, PLT, | RBC-BF, MN%/#, PMN%/#, | cerebrospinal fluid (CSF), |
| | NEUT% / #, LYMPH% / #, | and TC-BF parameters in | serous fluids (peritoneal, |
| | MONO% / #, EO% / #,<br>BASO% / #, NRBC% / #, | cerebrospinal fluid (CSF), | pleural) and synovial fluids.<br>Whole blood should be |
| | RDW-SD, RDW-CV, MPV, | serous fluids (peritoneal,<br>pleural) and synovial fluids. | collected in K2 or K3EDTA |
| | RET% / #, IRF, IG% / #, | Whole blood should be | anticoagulant and, Serous and |
| | RET-He, IPF, HPC | collected in K2 or K3EDTA | Synovial fluids in K2EDTA |
| | WBC-BF, RBC-BF, | anticoagulant and, Serous | anticoagulant to prevent clotting |
| | MN% / #, PMN%/ #, | and Synovial fluids in | of fluid. The use of |
| | TC-BF#. | K2EDTA anticoagulant to | anticoagulants with CSF |
| | | prevent clotting of fluid. The | specimens is neither required |
| | | use of anticoagulants with | nor recommended. |
| | | CSF specimens is neither | |
| | | required nor recommended. | |
| | | SIMILARITIES | |
| Sample Type | Whole blood<br>Body Fluids | Whole Blood<br>Body Fluids | Whole Blood<br>Body Fluids |
| Principles | Performs hematology<br>analyses according to the<br>Hydro Dynamic Focusing<br>(DC Detection), flow<br>cytometry method (using a | SAME | SAME |
| | SLS-hemoglobin method. | | |
| Parameters | Whole Blood Mode:<br>WBC, RBC, HGB, HCT,<br>MCV, MCH, MCHC, PLT,<br>NEUT%/#, LYMPH%/#,<br>MONO%/#, EO%/#,<br>BASO%/#, NRBC%/#,<br>RDW-CV, RDW-SD, MPV,<br>RET%/#, IRF, IG%/#, RET-<br>He#, IPF.<br>Body Fluid Mode:<br>WBC-BF, RBC-BF,<br>MN%/#, PMN%/#, TC-BF# | Whole Blood Mode:<br>WBC, RBC, HGB, HCT,<br>MCV, MCH, MCHC, PLT<br>(PLT-I, PLT-F), NEUT%/#,<br>LYMPH%/#, MONO%/#,<br>EO%/#, BASO%/#,<br>NRBC%/#, RDW-CV,<br>RDW-SD, MPV, RET%/#,<br>IRF, IG%/#, RET-He#, IPF.<br>Body Fluid Mode:<br>WBC-BF, RBC-BF,<br>MN%/#, PMN%/#, TC-BF# | Whole Blood Mode:<br>WBC, RBC, HGB, HCT, MCV,<br>MCH, MCHC, PLT (PLT-I,<br>PLT-F), NEUT%/#,<br>LYMPH%/#, MONO%/#,<br>EO%/#, BASO%/#, NRBC%/#,<br>RDW-CV, RDW-SD, MPV,<br>RET%/#, IRF, IG%/#, RET-<br>He#, IPF.<br>Body Fluid Mode:<br>WBC-BF, RBC-BF, MN%/#,<br>PMN%/#, TC-BF# |
| Reagents | SULFOLYSER (Lyse) | SAME | SAME |
| Principles | Performs hematology<br>analysis according to the<br>RF/DC detection method,<br>Hydro Dynamic Focusing<br>(DC Detection), flow<br>cytometry method (using a<br>semiconductor laser), and<br>SLS hemoglobin method. | SAME | SAME |
| Modes of<br>Operation | Sampler Analysis Mode<br>Manual Closed Analysis<br>Mode<br>Body Fluid Analysis<br>Mode | SAME | SAME |
| Measuring<br>Channels | RET/PLT | SAME | SAME |
| Equivalency<br>Data | Proven performance in FDA<br>submission | Data consisting of Accuracy,<br>Precision, Linearity and<br>Carryover were collected to<br>show performance to the<br>manufacturer's specification<br>for the Body Fluid mode.<br>This analysis supports the<br>claim that the XN-10<br>analyzer is substantially<br>equivalent to the XE-5000. | Data consisting of Accuracy,<br>Precision, Linearity and<br>Carryover were collected to<br>show performance to the<br>manufacturer's specification for<br>the Body Fluid mode. This<br>analysis supports the claim that<br>the XN-20 analyzer is<br>substantially equivalent to the<br>XE-5000. |
| | DIFFERENCES | | |
| | Predicate XE-5000<br>(K071967) | | XN-Series<br>(XN-10, XN-20) |
| Item | | XN-10 | XN-20 |
| Controls &<br>Calibrators | Whole Blood<br>e-Check (XE) - 3 Levels<br>Whole Blood Stability<br>Unopened 84 days | Whole Blood<br>*XN-Check - 3 Levels<br>Whole Blood Stability<br>Unopened 84 days | Whole Blood<br>*XN-Check - 3 Levels<br>Whole Blood Stability<br>Unopened 84 days |
| | XE Calibrator | *XN-10 Calibrator | *XN-20 Calibrator |
| | (X CAL) | (XN CAL) | (XN CAL) |
| | Not Available | Platelet F Calibrator<br>(XN CAL PF) | Platelet F Calibrator<br>(XN CAL PF) |
| | Not Available | Body Fluid<br>XN Check BF -- 2 Levels<br>*Product name change<br>only. | Body Fluid<br>XN Check BF - 2 Levels<br>*Product name change only. |
| IPU | Single Module connect | Multi-Module connect | Multi-Module connect |
| Modes of Operation | Manual Open Cap Analysis<br>Mode<br>(Operator presents sample<br>to aspiration needle) | Manual Open Cap<br>Analysis Mode<br>(Sample placed in tube<br>holder position) | Manual Open Cap Analysis<br>Mode<br>(Sample placed in tube holder<br>position) |
| | Capillary Analysis Mode<br>Dilute sample 1:5 | Pre-dilute Analysis Mode<br>Dilute sample 1:7 | Pre-dilute Analysis Mode<br>Dilute sample 1:7 |
| | Not Available | Low WBC Mode (LWBC) | Low WBC Mode<br>(LWBC) |
| Sample Type | Umbilical Cord Blood | Not Available | Not Available |
| Parameters | HPC | Not Available | Not Available |
| Sample Aspiration<br>/Fluidic Pathway | Two pathways | Single pathway | Single pathway |
| Dimensions of Main<br>Unit (Including<br>Sampler Unit) | Width: 706mm<br>Height: 711mm<br>Depth: 912mm | Width: 645mm<br>Height: 855mm<br>Depth: 755mm<br>(Single Unit) | Width: 645mm<br>Height: 855mm<br>Depth: 755mm<br>(Single Unit) |
| Weight (kg)<br>Including Sampler | 93<br>(Single Unit) | 78<br>…