Sysmex XN-L Automated Hematology Analyzer

K160538 · Sysmex America, Inc. · GKZ · Dec 22, 2016 · Hematology

Device Facts

• Record ID: K160538
• Device Name: Sysmex XN-L Automated Hematology Analyzer
• Applicant: Sysmex America, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Dec 22, 2016
• 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. The performance of this device has not been established in pediatric patients under the age of 2 years.

Device Story

Sysmex XN-L is an automated hematology analyzer for clinical laboratories. It processes whole blood (K2/K3 EDTA) and body fluids (CSF, peritoneal, pleural, synovial). The system uses electrical impedance, semiconductor laser flow cytometry, and cyanide-free SLS hemoglobin methods. It features a Main Unit for aspiration, dilution, mixing, and analysis, and a Pneumatic Unit for pressure/vacuum. Operators interface via a touchscreen monitor. The device performs automated cell classification and enumeration using adaptive cluster analysis of forward scatter and fluorescence signals. Results are displayed for clinician review to aid in hematological screening. The device supports manual or barcode-based specimen identification and offers both automated rack-based (Sampler) and manual tube sampling modes. It provides quantitative data on WBC, RBC, HGB, HCT, PLT, and differential counts, assisting in patient diagnosis and monitoring.

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. Reference intervals verified for whole blood. All predetermined acceptance criteria met, demonstrating performance equivalent to predicate.

Technological Characteristics

Automated hematology analyzer using DC sheath flow detection, semiconductor laser flow cytometry, and SLS-hemoglobin method. Measures whole blood and body fluids. External touchscreen monitor interface. Connectivity for data management. Software utilizes rule-based rerun/reflex logic. System includes main unit and pneumatic unit.

Indications for Use

Indicated for in vitro diagnostic screening of patient populations in clinical laboratories. Analyzes venous and capillary whole blood and body fluids (cerebrospinal, peritoneal, pleural, synovial). Not established for pediatric patients under 2 years of age.

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)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 22, 2016

Sysmex America, Inc. Ms. Sharita Brooks Sr. Manager, Regulatory Affairs 577 Aptakistic Road Lincolnshire, IL 60069

Re: K160538

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: December 12, 2016 Received: December 13, 2016

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

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CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Leonthena R. Carrington, MS, MBA, MT(ASCP) 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K160538

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 whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%H, LYMPH%4, 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, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDT A 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.

The performance of this device has not been established in pediatric patients under the age of 2 years.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains the logo for Sysmex. The logo features 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 a bold, sans-serif font, colored in a matching shade of blue.

## 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: k160538

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: | February 25, 2016 |

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 CAL™ (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 contains the Sysmex logo. The logo features an abstract graphic in shades of blue and green, resembling a stylized wave or ribbon. To the right of the graphic, the word "sysmex" is written in lowercase, using a bold, sans-serif font and a blue color that matches the graphic.

### 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 bodyfluid parameters by means of electrical impedance, laser light scattering, and fluorescentlabeling. 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%/#, 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.

The performance of this device has not been established in pediatric patients under the age of 2 years.

### Summary of Substantial Equivalence:

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

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Image /page/5/Picture/0 description: The image shows the Sysmex logo. The logo features 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 bold, sans-serif font and a blue color that matches the graphic element.

## 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)<br>are quantitative multi-parameter<br>automated hematology analyzers intended<br>for <i>in vitro</i> diagnostic use in screening<br>patient populations found in clinical<br>laboratories. The XN-Series modules<br>classify and enumerate the following<br>parameters in whole blood: WBC, RBC,<br>HGB, HCT, MCV, MCH, MCHC, PLT,<br>NEUT%/#, LYMPH%/#, MONO%/#,<br>EO%/#, BASO%/#, IG%/#, RDW-CV,<br>RDW-SD, MPV, NRBC%/#, RET%/#,<br>IPF, IRF, RET-He and has a Body Fluid<br>mode for body fluids. The Body Fluid<br>mode enumerates the WBC-BF,<br>RBC-BF, MN%/#, PMN%/# and TC-BF<br>parameters in cerebrospinal fluid (CSF),<br>serous fluids (peritoneal, pleural) and<br>synovial fluids. Whole blood should be<br>collected in K2 or K3EDTA anticoagulant<br>and, Serous and Synovial fluids in<br>K2EDTA anticoagulant to prevent<br>clotting of fluid. The use of<br>anticoagulants with CSF specimens is<br>neither required nor recommended. | The Sysmex® XN-L analyzer is a<br>quantitative multi-parameter automated<br>hematology analyzer intended for <i>in vitro</i><br>diagnostic use in screening patient<br>populations found in clinical laboratories.<br>The XN-L analyzer classifies and<br>enumerates the following parameters in<br>venous and capillary whole blood: WBC,<br>RBC, HGB, HCT, MCV, MCH, MCHC,<br>PLT, NEUT%/#, LYMPH%/#, MONO%/<br>#, EO%/#, BASO%/#, IG%/#, RDW-CV,<br>RDW-SD, MPV, RET%/#, IRF, RET-He<br>and has a Body Fluid mode for body<br>fluids. The Body Fluid mode enumerates<br>the WBC-BF, RBC-BF, MN%/#, PMN%/<br>#, and TC-BF# parameters in CSF,<br>peritoneal, pleural and synovial fluids.<br>Whole blood should be collected in K2 or<br>K3 EDTA anticoagulant and peritoneal,<br>pleural and synovial fluids in K2EDTA<br>anticoagulant to prevent clotting of fluid.<br>The use of anticoagulants with CSF<br>specimens is neither required nor<br>recommended.<br>The performance of this device has not<br>been established in pediatric patients<br>under the age of 2 years. |
| Specimen<br>Type | Whole Blood and Body Fluids (CSF and<br>Peritoneal, Pleural, Synovial Fluids) | SAME |
| Test<br>Principle | Performs hematology analyses according<br>to the Hydro Dynamic Focusing (DC<br>Detection), flow cytometry method (using<br>a semiconductor laser), and SLS-<br>hemoglobin method. | SAME |
| Parameters | Whole Blood Mode:<br>WBC, RBC, HGB, HCT, MCV, MCH,<br>MCHC, PLT, NEUT%/#, LYMPH%/#,<br>MONO%/#, EO%/#, BASO%/#, RDW-<br>CV, RDW-SD, MPV, RET%/#, IRF,<br>IG%/#, RET-He#<br>Body Fluid Mode:<br>WBC-BF, RBC-BF, MN%/#, PMN%/#,<br>TC-BF# | SAME |
| | Predicate Analyzer<br>XN-Series (XN-10)a<br>K112605 | Proposed Analyzer<br>XN-L |
| Item | | |
| Reagents | K112605<br>CELLPACK® DCL (Diluent)<br>CELLPACK® DFL (Diluent)<br>Lysercell™ WDF (Lyse)<br>Fluorocell™ WDF (Stain)<br>Fluorocell™ RET (Stain)<br>SULFOLYSER® (Lyse) | SAME |
| Analysis<br>Modes | Sampler Analysis Mode<br>(rack autoloader)<br>Whole Blood Mode<br><br>Manual Analysis Mode<br>Whole Blood Mode<br>LWBC Analysis Mode<br>Pre-Dilute Analysis Mode<br>Body Fluid Mode | SAME |
| 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 (K120742)<br>XN CAL™ (K120745)<br><br>Body Fluid<br>XN CHECK™ BF 2 Levels (K120744)<br><br>Whole Blood Linearity<br>Range Check X III (K960557)<br>Retic Chex (K000115) | SAME |
| Cleaning<br>Detergent | CELLCLEAN AUTO™ | SAME |
| Software/<br>Hardware | Rules based rerun/reflex | SAME |
| <b>Differences</b> | | |
| Parameters | PLT (PLT-F), NRBC%/#, IPF | Not Available |
| Reagents | K112605<br>Lysercell™ WNR (Lyse)<br>Fluorocell™ WNR (Stain)<br>Fluorocell™ PLT (Stain) | Not Available<br>Not Available<br>Not Available |
| Measuring<br>Channels | WNR, PLT-F | Not Available |
| Item | Predicate Analyzer<br>XN-Series (XN-10)a<br>K112605 | Proposed Analyzer<br>XN-L |
| Controls/<br>Calibrators | XN CAL™ PF – (K120747) | Not Available |
| | Not Available | XN-L CHECK™ b |
| Throughput | Whole Blood Mode<br>100 samples/hour maximum depending<br>on mode used. | Whole Blood Mode<br>60 samples/hour maximum depending on<br>mode used. |
| | Body Fluid Mode | Body Fluid Mode |
| | 40 samples/hour maximum | 30 samples/hour maximum |
| Sample<br>Aspiration<br>Volumes | Sampler Mode - 88 μL | Sampler Mode - 25 μL |
| | Manual (Closed Cap) Mode - 88 μL | Manual (Closed Cap) Mode - 25 μL |
| | Manual (Open Cap) Mode - 88 μL | Manual (Open Cap) Mode - 25 μL |
| | Dilution Mode - 70 μL | Dilution Mode - 70 μL |
| | Body Fluid Mode - 88 μL | Body Fluid Mode - 70 μL |

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Image /page/6/Picture/0 description: The image shows the Sysmex logo. The logo features a stylized graphic element in shades of blue and green, resembling a wave or a flowing ribbon. To the right of the graphic is the word "sysmex" in a sans-serif font, with the letters in a dark blue color.

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Image /page/7/Picture/0 description: The image shows the Sysmex logo. The logo consists of a stylized graphic element above the word "sysmex". The graphic element is a combination of blue and green shapes, with the blue shapes resembling waves and the green shape resembling a mountain. The word "sysmex" is written in blue, sans-serif font.

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Image /page/8/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 a stylized leaf. 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.

8 Intended use for the predicate analyzer was cleared in submission K112605. All information listed for the predicate analyzer refers to the XN-10 module.

b Control material specific for the XN-L analyzer.

The XN-L analyzer's Indications for Use statement is similar to the predicate device with minor variation. The XN-L analyzer also has similar technological characteristics as the predicate device with minor variation. Both devices measure similar parameters and utilize most of the same reagents, controls, calibrators, and cleaning detergent. The datacollection software functionality, communication method with data management software functionality, monitor software, connectivity, and communication are similar to the predicate device with minor variation.

The XN-L analyzer differs from the predicate with a slower throughput and smaller sample aspiration volumes, fewer measuring channels, and fewer parameters measured, it is very similar in all other electronic and technological characteristics related to automated hematology measurements of the predicate device to assure equivalence. In addition. XN-L CHECK™is a control material which is specific for the XN-L analyzer. The XN-LCHECK™ or the XN CHECK™ may be used with the XN-L analyzer. Performance data are provided to support this. The results of all performance testing demonstrate substantial equivalence.

#### Summary of Performance Testing:

Clinical testing was conducted on the XN-L analyzer to show equivalent performance to the XN-Series analyzers. Testing included:

- . Whole Blood Analysis
- o Accuracy Evaluation
- Precision Evaluation: Reproducibility o
- o Precision Evaluation: Repeatability
- o Linearity Evaluation

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Image /page/9/Picture/0 description: The image contains the Sysmex logo. The logo features a stylized graphic element in shades of blue and green, resembling a wave or a leaf. To the right of the graphic…