Sysmex XN-L Automated Hematology Analyzer

K182389 · Sysmex America, Inc. · GKZ · Jan 25, 2019 · Hematology

Device Facts

• Record ID: K182389
• Device Name: Sysmex XN-L Automated Hematology Analyzer
• Applicant: Sysmex America, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Jan 25, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, 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, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, 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

Quantitative multi-parameter automated hematology analyzer; processes venous/capillary whole blood and body fluids (CSF, peritoneal, pleural, synovial). Uses electrical impedance, laser light scattering, and fluorescent labeling; performs DC sheath flow detection, flow cytometry (semiconductor laser), and SLS-hemoglobin method. Main unit aspirates, dilutes, mixes, and analyzes samples; pneumatic unit provides pressure/vacuum. External touchscreen monitor used for operation and data processing. Used in clinical laboratories by trained personnel. Automatically classifies cells from aspiration to result output. Provides clinicians with hematological parameters to assist in patient screening and clinical decision-making.

Clinical Evidence

Bench testing only. Performance evaluated via accuracy, precision (repeatability/reproducibility), linearity, carryover, stability, and limits of blank/detection/quantitation for both whole blood and body fluid modes. Results met predetermined acceptance criteria, demonstrating equivalence to predicate XN-Series analyzers. Real-world data included to support use in pediatric patients under 2 years.

Technological Characteristics

Automated multi-parameter hematology analyzer. Methods: DC Sheath Flow Detection, semiconductor laser flow cytometry, SLS hemoglobin method. Materials: K2/K3EDTA anticoagulated samples. Connectivity: Standalone, non-wireless data transmission. Software: Rule-based rerun/reflex. Sterilization: N/A (IVD instrument). Compliance: IEC 60825-1 (laser safety), IEC 61010-1/2-081/2-101 (electrical/IVD safety), IEC 61326-2-6 (EMC).

Indications for Use

Indicated for in vitro diagnostic screening of patient populations, including pediatric subjects from birth to <2 years of age, in clinical laboratories. Analyzes venous and capillary whole blood and specific body fluids (CSF, peritoneal, pleural, 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 XN-Series (XN-10, XN-20) Automated Hematology Analyzer (K112605)

Reference Devices

• XN CAL (K160585)
• XN-L CHECK (K160586)
• XN CHECK (K160590)
• XN CHECK BF (K160588)
• Whole Blood Linearity Range Check X III (K960557)
• Retic Chex (K000115)
• XN CAL PF (K120747)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

January 25, 2019

Sysmex America, Inc. Sharita Brooks Sr. Manager, Regulatory Affairs 577 Aptakisic Road Lincolnshire, Illinois 60069

Re: K182389

Trade/Device Name: Sysmex XN-L Automated Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: August 31, 2018 Received: September 4, 2018

Dear Sharita 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Leonthena R. Carrington -S

Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182389

#### Device Name

Sysmex XN-L Automated Hematology Analyzer

#### Indications for Use (Describe)

The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%#, MON0%#, EO%#, IG%#, RDW-CV, RDW-SD, MPV, RET%#, 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, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size: 100%;"> <span style="text-decoration: overline;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span style="font-size: 100%;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|

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Image /page/3/Picture/0 description: The image shows the Sysmex logo. The logo consists of a stylized graphic element in shades of blue and green, resembling a wave or abstract shape. To the right of the graphic is the word "sysmex" in lowercase, using a sans-serif font and a blue color that matches the graphic element.

# 5. 510(K) SUMMARY

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:________________________________________________________________________________________________________________________________________________

Submitter's name, address, telephone number, a contact person, and date the summary was prepared:

| Submitter's Name: | Sysmex America, Inc. |
|-------------------------------|-----------------------------------------------|
| Submitter's Address: | 577 Aptakistic Road<br>Lincolnshire, IL 60069 |
| Submitter's Telephone: | [phone] |
| Submitter's FAX: | [phone] |
| Submitter's Contact: | Sharita Brooks |
| Date 510(k) Summary Prepared: | |

Name of the device, including the trade or proprietary name, the common or usual name, and the classification name:

| Proprietary Name: | Sysmex® XN-L Automated Hematology Analyzer |
|-------------------------|--------------------------------------------|
| Common Name: | Automated Hematology Analyzer |
| Regulation Description: | Automated Differential Cell Counter |
| Regulation Section: | 21 CFR 864.5220 |
| Device Class: | 2 |
| Product Code: | GKZ |

Related Items:

Product Code: 81GIF CELLPACK® DCL (Diluent) CELLPACK® DST (Diluent) CELLPACK® DFL (Diluent)

# Product Code: 81KJK

Fluorocell™ WDF (Dye) Fluorocell™ RET (Dye)

# Product Code: 81JPK

XN CHECK™ (Control) XN CHECK™ BF (Control) XN-L CHECK™ (Control)

# Product Code: 81GGK

SULFOLYSER® (Lyse) Lysercell™ WDF (Lyse)

# Product Code: 81KSA

XN CALTM (Calibrator)

Product Code: 81JCB CELLCLEAN™ AUTO

Predicate Device and 510(k) number: Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzer, K112605

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Image /page/4/Picture/0 description: The image shows the Sysmex logo. The logo consists of a stylized graphic element in blue and green, resembling a wave or abstract shape. To the right of the graphic is the word "sysmex" in lowercase, using a sans-serif font and colored in blue.

# Description of the Device:

The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates whole blood and body fluid parameters by means of electrical impedance, laser light scattering, and fluorescent labeling. Tests are performed on venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant and body fluids (peritoneal, pleural and synovial) collected in K2EDTA anticoagulant and cerebrospinal fluid that is not collected in anticoagulant. The instrument consists of two principal units: (1) Main Unit which will aspirate, dilute, mix, and analyze whole blood and body fluid samples and (2) Pneumatic Unit which supplies pressure and vacuum to the analyzer. The XN-L analyzer performs analysis using the following methods: DC Sheath Flow Detection Method, Flow Cytometry Methods using a Semiconductor Laser, and SLS-hemoglobin Method. Particle characterization and identification is based on detection of forward scatter, fluorescence, and adaptive cluster analysis. The XN-L analyzer automatically classifies cells from whole blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results.

The XN-L has an external monitor with touch screen capability that is used to operate the instrument and process data from the Main Unit. The monitor also allows operator interfacing with the instrument by use of a panel keyboard.

### Statement of Intended Use:

The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#. LYMPH%/#. MONO%/#. EO%/#. BASO%/#. IG%/#. RDW-CV, RDW-SD. MPV, RET%/#, 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 cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.

# Proposing removal of the limitation to pediatric patients under the age of 2 years from our current intended use.

#### Summary of Substantial Equivalence:

Table 5-1 compares the Sysmex XN-L Automated Hematology analyzer with the XN-Series (XN-10, XN-20) Automated Hematology analyzer.

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Image /page/5/Picture/0 description: The image shows the Sysmex logo. The logo consists of a stylized graphic element in shades of blue and green, resembling waves or abstract shapes. To the right of the graphic is the word "sysmex" in a sans-serif font, colored in blue. The logo appears to be clean and modern in design.

# Table 5-1: Comparison of the Predicate XN-10 and the Proposed XN-L Automated Hematology Analyzers

| Item | Predicate Analyzer<br>XN-Series (XN-10)a<br>K112605 | Proposed Analyzer<br>XN-L | | |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Similarities | | | | |
| Intended Use | The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for <i>in vitro</i> 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. | The Sysmex® XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for <i>in vitro</i> diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, 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 CSF, peritoneal, pleural and synovial fluids. Whole blood should be collected in K2 or K3 EDTA anticoagulant and peritoneal, pleural and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended. | | |
| | Specimen<br>Type | Whole Blood and Body Fluids (CSF and Peritoneal, Pleural, Synovial Fluids) | SAME | |
| | Test<br>Principle | Performs hematology analyses according to the Hydro Dynamic Focusing (DC Detection), flow cytometry method (using a semiconductor laser), and SLS-hemoglobin method. | SAME | |
| | | Parameters | Whole Blood Mode:<br>WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, IG%/#, RET-He#<br>Body Fluid Mode:<br>WBC-BF, RBC-BF, MN%/#, PMN%/#, TC-BF# | SAME |
| | | | Item | Predicate Analyzer<br>XN-Series (XN-10)a<br>K112605 |
| | Reagents | | K112605 | SAME |
| | | | CELLPACK® DCL (Diluent) | |
| | | | CELLPACK® DFL (Diluent) | |
| | | | Lysercell™ WDF (Lyse) | |
| Fluorocell™ WDF (Stain) | | | | |
| Fluorocell™ RET (Stain)<br>SULFOLYSER® (Lyse) | | | | |
| Analysis<br>Modes | Sampler Analysis Mode<br>(rack autoloader)<br>Whole Blood Mode | SAME | | |
| | Manual Analysis Mode | | | |
| | Whole Blood Mode<br>LWBC Analysis Mode<br>Pre-Dilute Analysis Mode<br>Body Fluid Mode | | | |
| | | | | |
| Sample<br>Aspiration/<br>Fluidic<br>Pathway | Single Pathway | SAME | | |
| Measuring<br>Channels | RBC/PLT, HGB, RET, WDF | SAME | | |
| Controls/<br>Calibrators/<br>Linearity<br>Material | Whole Blood<br>XN CHECK™ 3 Levels (K160590)<br>XN CAL™ (K160585) | SAME | | |
| | Body Fluid | | | |
| | XN CHECK™ BF 2 Levels (K160588) | | | |
| | Whole Blood Linearity | | | |
| | Range Check X III (K960557)<br>Retic Chex (K000115) | | | |
| Cleaning<br>Detergent | CELLCLEAN AUTO™ | SAME | | |
| Software/<br>Hardware | Rules based rerun/reflex | SAME | | |
| Differences | | | | |
| Parameters | PLT (PLT-F), NRBC%/#, IPF | Not Available | | |
| Reagents | K112605 | Not Available | | |
| | Lysercell™ WNR (Lyse) | | | |
| | Fluorocell™ WNR (Stain)<br>Fluorocell™ PLT (Stain) | |…