SYSMEX XE-5000

K071967 · Sysmex America, Inc. · GKZ · Nov 20, 2007 · Hematology

Device Facts

• Record ID: K071967
• Device Name: SYSMEX XE-5000
• Applicant: Sysmex America, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Nov 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The Sysmex XE-5000 is an automated hematology analyzer for in-vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 classifies and enumerates the same parameters as the XE-2100 using whole blood as described below, cord blood for HPC and has a body fluid mode for body fluids. The Body Fluid mode analyzes WBC-BF, RBC-BF, MN%/#, PMN%/# and TC-BF in body fluids (cerebrospinal fluids (CSF), serous fluids, and synovial fluids with EDTA as needed). WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMP %/#, MONO %/#, EO%/#, BASO %/#, NRBC, RDW-SD, RDW-CV, MPV, RET %/#, IRF, IG%/#, HPC#, RET-He, IPF, WBC-BF, RBC-BF, MN%/#, PMN%/#, TC-BF#

Device Story

Multi-parameter hematology analyzer; processes anticoagulated whole blood and body fluids. System components: Main Unit (aspiration, dilution, mixing, analysis), Auto Sampler (up to 100 tubes), and Information Processing Unit (IPU) for data management/operator interface. Methods: RF/DC detection, sheath flow DC detection, and semiconductor laser flow cytometry. Particle identification via forward scatter, fluorescence, and adaptive cluster analysis. Operator loads samples via manual, capillary, or automated sampler modes. IPU displays results, graphics, and flags; supports host computer transmission. Enables automated cell classification and enumeration, reducing manual microscopy requirements. Benefits: rapid, standardized quantitative analysis of blood and body fluid cellular components.

Clinical Evidence

Bench testing only. Data collected for carryover, linearity, accuracy, and reproducibility to demonstrate performance against manufacturer specifications for the body fluid mode. Comparison of XE-5000 body fluid mode to XE-2100 demonstrated excellent correlation.

Technological Characteristics

Automated hematology analyzer. Methods: RF/DC detection, sheath flow DC detection, semiconductor laser flow cytometry. Analyzes whole blood and body fluids. Connectivity: IPU with Windows 2000 OS, barcode reader, printer/host output. Calibration: XE Calibrator (X Cal). QC: e-Check (XE) 3-level control. Software: IPU PIM (Patient Information Manager) for data processing and user-definable flagging.

Indications for Use

Indicated for in-vitro diagnostic screening of patient populations in clinical laboratories using whole blood, cord blood, or body fluids (CSF, serous, synovial) to classify and enumerate hematological parameters.

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-2100 Body Fluid (K040073)

Submission Summary (Full Text)

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## 5. 510(k) SUMMARY of the XE-5000

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:

| 1. Submitted by: | Sysmex America, Inc.<br>One Nelson C. White Parkway<br>Mundelein, IL 60060<br>Phone: [phone]; FAX: [phone]<br>Contact person: Nina Gamperling<br>Date prepared: July 13, 2007 | |
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| 2. Name of Device: | Trade or proprietary name: Sysmex® XE-5000<br>Common name: Automated Hematology Analyzer.<br>Classification name:<br>Sysmex® XE-Series, Automated Hematology, an Automated<br>Differential Cell Counter (21 CFR 864.5220) is a Class II device.<br>Related Items:<br>CELLPACK™ (Diluent) | Product Code: 81GIF |
| | CELLSHEATH™ (Diluent) | Product Code: 81GIF |
| | STROMATOLYSER-FB™ (Lyse) | Product Code: 81GGK |
| | STROMATOLYSER-4DL™ (Lyse) | Product Code: 81GGK |
| | STROMATOLYSER-4DS™ (Stain) | Product Code: 81KJK |
| | STROMATOLYSER-NR™ (Diluent) | Product Code: 81GGK |
| | STROMATOLYSER-NR™ (Stain) | Product Code: 81KJK |
| | STROMATOLYSER-IM™ (Lyse) | Product Code: 81GGK |
| | SULFOLYSER (Lyse) | Product Code: 81GGK |
| | RET-SEARCH II (Diluent) | Product Code: 81GIF |
| | RET-SEARCH II (Stain) | Product Code: 81KJK |
| | XE Calibrators | Product Code: 81KSA |
| | e-Check (XE) (Control) | Product Code: 81JPK |
| | Option:<br>Graphic printer<br>Bar code Reader | |
| 3. Predicate Method: | Sysmex® XE-2100 Body Fluid (K040073-Cleared March 18, 2004) | |
| 4. Device Description: | The Sysmex® XE-5000 is part of the XE-Series instrument line. It is a<br>multi-parameter hematology analyzer intended to perform tests in anti-<br>coagulated blood and body fluids. The instrument consists of three<br>principal units: (1) Main Unit which aspirates, dilutes, mixes and<br>analyzes blood and body fluid samples; (2) Auto Sampler Unit supplies<br>samples to the Main Unit automatically; (3) IPU (Information<br>Processing Unit) which processes data from the Main Unit and provides<br>the operator interface with the system. The XE-5000 is equipped with a<br>Sampler that provides continuous automated sampling for up to 100<br>tubes.<br>The XE-5000 performs analyses using the following methods: RF/DC<br>Detection Method, Sheath Flow DC Detection Method, and Flow<br>Cytometry Methods using a Semiconductor Laser. Particle<br>characterization and identification is based on detection of forward | |
| 5. Intended Use: | scatter, fluorescence and adaptive cluster analysis. Using the same<br>reagents as the XE-2100, the XE-5000 automatically classifies cells<br>from blood and body fluids and carries out all processes automatically<br>from aspiration of the sample to outputting the results. | |
| | The body fluid analysis mode of the XE-5000 uses the 4DIFF<br>scattergram & the RBC distribution obtained from a specialized<br>analysis sequence to calculate & display the WBC (WBC-BF) counts,<br>mononuclear cell (MN) / polymorphonuclear cell (PMN) counts &<br>percentages, TC-BF (Total Count) & RBC (RBC-BF) counts found in<br>the body fluid. | |
| | Analysis results and graphics are displayed on the IPU screen. They<br>can be printed on any of the available printers or transmitted to a Host<br>computer. | |
| | Sysmex® XE-5000 is an automated hematology analyzer for <i>in vitro</i><br>diagnostic use in screening patient populations found in clinical<br>laboratories. The XE-5000 classifies and enumerates the same<br>parameters as the XE-2100 using whole blood as described below, cord<br>blood for HPC and has a body fluid mode for body fluids. The Body<br>Fluid mode analyzes WBC-BF, RBC-BF, MN%/#, PMN%/# and TC-<br>BF in body fluids (cerebrospinal fluids (CSF), serous fluids, and<br>synovial fluids with EDTA, as needed). | |
| | WBC | White Blood Cell Count |
| | RBC | Red Blood Cell Count |
| | HGB | Hemoglobin |
| | HCT | Hematocrit |
| | MCV | Mean Cell Volume |
| | MCH | Mean Cell Hemoglobin |
| | MCHC | Mean Cell Hemoglobin Concentration |
| | PLT | Platelet Count |
| | NEUT% / # | Neutrophil Percent and Count |
| | LYMPH%/# | Lymphocyte Percent and Count |
| | ΜΟΝΟ%/# | Monocyte Percent and Count |
| | EO% / # | Eosinophil Percent and Count |
| | BASO%/# | Basophil Percent and Count |
| | NRBC%/# | Nucleated RBC Percent and Count |
| | RDW-SD | RBC Distribution Width-SD |
| | RDW-CV | RBC Distribution Width-CV |
| | MPV | Mean Platelet Volume |
| | RET% / # | Reticulocyte Percent and Count |
| | IRF | Immature Reticulocyte |
| | IG% / # | Immature Granulocyte Percent and Count |
| | HPC# | Hematopoietic Progenitor Cells |
| | RET-He | Reticulocyte Hemoglobin |
| | IPF | Immature Platelet Fraction |
| | WBC-BF | WBC count in the body fluid mode analysis. |
| | RBC-BF | RBC count in the body fluid mode analysis. |
| | MN% / # | Percent and number of mononuclear cells within WBC-BF. |
| | PMN%/# | Percent and number of polymorphonuclear cells in WBC-BF |
| | TC-BF# | The total count including WBC-BF and HF-BF# (the number<br>of particles which appear in a stronger fluorescence area in<br>DIFF scattergram) |

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| 6. Substantial<br>equivalence-<br>Similarities and<br>Differences: | Table 1 shows substantial equivalence of the XE-5000 to the XE-2100. |
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| 7. Conclusion | The XE-5000 demonstrates substantial equivalence to the XE-2100<br>Body Fluid application. |

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| | Sysmex XE-2100<br>Predicate | Sysmex XE-5000<br>Modification of Predicate | Similarity/<br>Difference |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Sysmex® XE-2100 Series<br>Hematology Analyzer is a<br>quantitative, automated<br>hematology analyzer and<br>leukocyte differential counter<br>for <i>in vitro</i> diagnostic use in<br>clinical laboratories. The<br>body fluid application adds a<br>quantitative, automated<br>procedure for analyzing<br>cerebrospinal fluid, serous<br>fluid and synovial fluid. | Sysmex® XE-5000 is an<br>automated hematology analyzer<br>for <i>in vitro</i> diagnostic use in<br>screening patient populations<br>found in clinical laboratories.<br>The XE-5000 classifies and<br>enumerates the same parameters<br>as the XE-2100 using whole<br>blood as described below, cord<br>blood for HPC and has a body<br>fluid mode for body fluids. The<br>Body Fluid mode analyzes<br>WBC-BF, RBC-BF, MN%/#,<br>PMN%/# and TC-BF in body<br>fluids (cerebrospinal fluids<br>(CSF), serous fluids, and<br>synovial fluids with EDTA, as<br>needed). | Both systems have the same<br>intended use but the XE-5000<br>has additional capillary and body<br>fluid parameters.<br><br>1) Body Fluid Mode has new<br>differential parameters (MN%/#<br>and PMN %/#) and detects WBC<br>and RBC cells at a lower level<br>than the XE-2100. The body<br>fluid mode is used on body fluid<br>samples with RBC counts<br>greater than $0.003 x 10^6$ /ul,<br>WBC counts greater than $0.01 x$<br>$10^3$ /ul for CSF and $0.030 x$<br>$10^3$ /ul for other body fluids and<br>WBC differential (MN%/# and<br>PMN %/#) for samples with<br>WBC counts.<br><br>2) Capillary mode on whole<br>blood includes differential with<br>NRBC#/% & IG#/%.<br><br>3) Addition of WBC-D<br>parameter on whole blood. |
| | Body Fluid Parameters:<br>WBC<br>RBC | Body Fluid Parameters:<br>WBC-BF<br>RBC-BF<br>MN%/ #<br>PMN%/#<br>TC-BF# | |
| | Capillary Mode Parameters:<br>WBC<br>RBC<br>HGB<br>HCT<br>MCV<br>MCH<br>MCHC<br>PLT<br>RET%/# | Capillary Mode Parameters:<br>WBC<br>RBC<br>HGB<br>HCT<br>MCV<br>MCH<br>MCHC<br>PLT<br>RET%/#<br>NEUT% /#<br>LYMPH%/#<br>ΜΟΝΟ%/#<br>EO% / #<br>BASO% /#<br>NRBC%/#<br>IG% / # | |
| Methodology | The XE-2100 performs<br>analyses using the following<br>methods: RF/DC Detection<br>Method, Sheath Flow DC<br>Detection Method, and Flow<br>Cytometry Methods using a<br>Semiconductor Laser. The | The XE-5000 performs analyses<br>using the following methods:<br>RF/DC Detection Method,<br>Sheath Flow DC Detection<br>Method, and Flow Cytometry<br>Methods using a Semiconductor<br>Laser. The RF/DC detection | Both systems use the same<br>methodology. |

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| | detects the size of the cells by<br>changes in direct-current<br>resistance & the density of the<br>cell interior by changes in<br>radio-frequency resistance.<br>Cells pass through the aperture<br>of the detector surrounded by<br>sheath fluid using the sheath<br>flow method. The principle of<br>flow cytometry is also used.<br>A semiconductor laser beam is<br>emitted to the cells passing<br>through the flow cell. The<br>forward scattered light is<br>received by the photodiode, &<br>the lateral scattered light &<br>lateral fluorescent light are<br>received by the photo<br>multiplier tube. This light is<br>converted into electrical<br>pulses, thus making it possible<br>to obtain cell information. | cells by changes in direct-current<br>resistance & the density of the<br>cell interior by changes in radio-<br>frequency resistance. Cells pass<br>through the aperture of the<br>detector surrounded by sheath<br>fluid using the sheath flow<br>method. The principle of flow<br>cytometry is also used. A<br>semiconductor laser beam is<br>emitted to the cells passing<br>through the flow cell. The<br>forward scattered light is<br>received by the photodiode, &<br>the lateral scattered light &<br>lateral fluorescent light are<br>received by the photo multiplier<br>tube. This light is converted into<br>electrical pulses, thus making it<br>possible to obtain cell<br>information. | |
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| Reagents | CELLPACKTM (Diluent)<br>CELLSHEATHTM (Diluent)<br>STROMATOLYSER-FBTM (Lyse)<br>STROMATOLYSER-4DLTM (Lyse)<br>STROMATOLYSER-4DSTM (Stain)<br>STROMATOLYSER-NRTM (Diluent)<br>STROMATOLYSER-NRTM (Stain)<br>STROMATOLYSER-IMTM (Lyse)<br>SULFOLYSER (Lyse)<br>RET-SEARCH II (Diluent)<br>RET-SEARCH II (Stain) | CELLPACKTM (Diluent)<br>CELLSHEATHTM (Diluent)<br>STROMATOLYSER-FBTM (Lyse)<br>STROMATOLYSER-4DLTM (Lyse)<br>STROMATOLYSER-4DSTM (Stain)<br>STROMATOLYSER-NRTM (Diluent)<br>STROMATOLYSER-NRTM (Stain)<br>STROMATOLYSER-IMTM (Lyse)<br>SULFOLYSER (Lyse)<br>RET-SEARCH II (Diluent)<br>RET-SEARCH II (Stain) | The XE-2100 and the XE-5000<br>use the same reagents. |
| Quality<br>Control/<br>Calibrator | e-Check—3 levels<br>XE Calibrator (X Cal) | e -Check (XE) —3 levels<br>XE Calibrator (X Cal) | The XE-2100 and the XE-5000<br>use the same calibrator, but the<br>XE-5000 uses a specific quality<br>control material, e -Check (XE)<br>that has been previously cleared. |
| Software/<br>Hardware<br>Differences | The XE-pro software was<br>added to the original XE-2100<br>in order to include additional<br>master programs (HPC, IG,<br>RET, IPF) and perform Body<br>Fluid analysis. | The XE-5000 uses the same XE-<br>pro software and includes<br>additional masters (HPC, IG,<br>RET, IPF) along with a Body<br>Fluid mode in the initial standard<br>software model. | The XE-5000 performs the same<br>as the XE-2100 with the HPC,<br>IG, RET and IPF masters along<br>with a Body Fluid mode that has<br>additional parameters (TC-BF,<br>MN%/# and PMN %/#). The<br>XE-5000 capillary mode<br>includes the differential, NRBC<br>and IG parameters. |
| Specimen<br>Type | Random whole blood and<br>body fluid samples | Random whole blood and body<br>fluid samples. | Both systems use the same<br>specimen types. |
| Throughput | Approximately 113-150<br>samples/hour depending on<br>the mode used. | Approximately 113-150<br>samples/hour depending on the<br>mode used. | Both systems have the same<br>throughput. |
| Equivalency<br>Data: | Performance was initially<br>established in XE-2100 510(k)<br>submission (K992875) & then<br>additional masters/parameters<br>were submitted in subsequent<br>submissions: | Performance of the XE-5000<br>whole blood mode is the same as<br>the XE-2100 with additional<br>masters. The Body Fluid mode<br>of the XE-5000 has additional<br>parameters. Comparison of the | Data consisting of carryover,<br>linearity, accuracy and<br>reproducibility was collected to<br>show performance to the<br>manufacturer's specification for<br>the Body Fluid mode. This |

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| XE-2100/HPC (K020496),<br>XE-2100/IG (K032039),<br>XE-Body Fluid (K040073),<br>XE-2100 RET/He (K050589),<br>XE-2100/IPF (K051199). | XE-5000 body fluid mode to the<br>XE-2100 demonstrated excellent<br>correlation. | analysis supports the claim that<br>the XE-5000 Body Fluid mode is<br>substantially equivalent to the<br>XE-2100 Body Fluid. |
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