Sysmex XR-Series (XR-10) Automated Hematology Analyzer

K250943 · Sysmex America, Inc. · GKZ · Jun 25, 2025 · Hematology

Device Facts

• Record ID: K250943
• Device Name: Sysmex XR-Series (XR-10) Automated Hematology Analyzer
• Applicant: Sysmex America, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Jun 25, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The XR-Series module (XR-10) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XR-Series module classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IPF, 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 K2EDTA 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 XR-10 is an automated hematology analyzer for whole blood and body fluids. It uses RF/DC detection, sheath flow DC detection, and semiconductor laser flow cytometry (SLS-hemoglobin method) to analyze samples. The system consists of a main unit, auto-samplers, an IPU for data processing, and a pneumatic unit. It processes samples automatically from aspiration to result output. The IPU displays results and graphics, which can be printed or transmitted to a host. It supports whole blood, pre-dilution, low WBC, and body fluid modes. The device aids clinicians in screening patient populations by providing quantitative hematological parameters, supporting diagnostic decision-making for various disease states.

Clinical Evidence

Clinical performance was evaluated via method comparison studies at three US sites using 865 whole blood and 397 body fluid samples. Flagging performance was assessed against manual microscopy and the predicate device. Precision, linearity, and stability studies were conducted per CLSI guidelines. Results showed high correlation (r ≥ 0.93 for most parameters) and met predefined acceptance criteria for sensitivity, specificity, and efficiency.

Technological Characteristics

Uses RF/DC detection, sheath flow DC detection, and semiconductor laser flow cytometry. SLS-hemoglobin method. Analyzes whole blood and body fluids. Connectivity via IPU to host computer. Software runs on Windows 10. Complies with IEC 60601-1-2, IEC 61326-2-6, ISO 14971, and IEC 62304.

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). No specific age or gender contraindications noted; anticoagulants required for whole blood and serous/synovial fluids to prevent clotting.

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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FDA U.S. FOOD & DRUG ADMINISTRATION

June 25, 2025

Sysmex America, Inc.
Yvonne Doswell
Senior Scientist
577 Aptakisic Road
Lincolnshire, Illinois 60069

Re: K250943
Trade/Device Name: Sysmex XR-Series (XR-10) Automated Hematology Analyzer
Regulation Number: 21 CFR 864.5220
Regulation Name: Automated differential cell counter
Regulatory Class: Class II
Product Code: GKZ
Dated: March 28, 2025
Received: March 28, 2025

Dear Yvonne Doswell:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250943 - Yvonne Doswell
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K250943 - Yvonne Doswell
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Takeesha Taylor-bell -S

Takeesha Taylor-Bell
Deputy Director
Division of Immunology and Hematology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250943 | |
| Device Name | |
| Sysmex XR-Series (XR-10) Automated Hematology Analyzer | |
| Indications for Use (Describe) The XR-Series module (XR-10) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XR-Series module classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IPF, 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 K2EDTA 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. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

# 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: K250943.

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

Submitter's Name: Sysmex America, Inc.

Submitter's Address: 577 Aptakisic Road
Lincolnshire, IL 60069

Submitter's Contact: Yvonne Doswell
Senior Scientist, Regulatory Affairs
E-Mail: [e-mail]
Phone: [phone]

Date 510(k) Summary Prepared: March 23, 2025

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

Proprietary Name: Sysmex XR-Series (XR-10) 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 Reagents, Controls and Calibrator:

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

Product Code: 81GGK
Lysercell WNR (Lyse)
Lysercell WDF II (Lyse)
SULFOLYSER (Lyse)

Product Code: 81KQC
Fluorocell WNR (Stain)
Fluorocell WDF (Stain)
Fluorocell RET (Stain)
Fluorocell PLT (Stain)

Product Code: 81KSA

Classified as Confidential

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Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

XN CAL (Calibrator)
XN CAL PF (Calibrator)

**Product Code: 81JPK**
XN CHECK (Quality Control)
XN CHECK BF (Quality Control)

**Product Code: 81JCB**
CELLCLEAN AUTO (Detergent)

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

**Description of the Device:**

The Sysmex XR-Series module (XR-10) is a quantitative multi-parameter hematology analyzer intended to perform tests on whole blood samples collected in K₂ or K₃EDTA and body fluids (pleural, peritoneal and synovial) collected in K₂EDTA anticoagulant. The analyzers can also perform tests on CSF, which should not be collected in any anticoagulant. The XR-Series analyzer consists of four principal units: (1) One Main Units (XR-10) which aspirates, dilutes, mixes, and analyzes blood and body fluid samples; (2) Two Auto Sampler Units (SA-10, SA-01) 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.

**Principles of Operation:**

The XR-10 analyzer performs analysis using the following methods: RF/DC Detection Method, Sheath Flow DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser and SLS-hemoglobin. The RF/DC detection method detects the size of the cells by changes in direct-current resistance and the density of the cell interior by changes in radio-frequency resistance. In the sheath flow method, cells pass through the aperture of the detector surrounded by sheath fluid. Flow cytometry is also used where a semiconductor laser beam is emitted to the cells passing through the flow cell. The forward scattered light is received by the photodiode, and the lateral scattered light and lateral fluorescent light are received by the photo multiplier tube. This light is converted into electrical pulses, thus making it possible to obtain cell information. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. The system carries out all processes automatically from aspiration of the sample to outputting results and uses Microsoft Windows Operating System.

The body fluid analysis mode of the XR-10 analyzer uses the 4 part differential scattergram and the RBC distribution obtained from a specialized analysis sequence to calculate and display the WBC (WBC-BF) counts, mononuclear cell (MN) / polymorphonuclear cell (PMN) counts and percentages, TC-BF (Total Count) & RBC (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.

Classified as Confidential

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Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

# Statement of Intended Use:

The XR-Series module (XR-10) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The XR-Series module classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IPF, 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 K2EDTA 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.

# Summary of Substantial Equivalence:

Table 1 compares the Sysmex XR-Series (XR-10) Automated Hematology Analyzer with the XN-20 Automated Hematology analyzer.

Table 1: Comparison of the Predicate XN-20 and the Proposed Sysmex XR-Series (XR-10) Automated Hematology Analyzer

| Item | Predicate Analyzer
XN-Series (XN-20)
K112605 | Proposed Analyzer
XR-Series (XR-10)
K250943 |
| --- | --- | --- |
| Similarities | | |
| 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 | The XR-Series module (XR-10) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The XR-Series module classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IPF, 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 K2EDTA or K3EDTA anticoagulant, and serous and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of |

Classified as Confidential

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Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Item | Predicate Analyzer
XN-Series (XN-20)
K112605 | Proposed Analyzer
XR-Series (XR-10)
K250943 |
| --- | --- | --- |
| | with CSF specimens is neither required nor recommended. | anticoagulants with CSF specimens is neither required nor recommended. |
| **Specimen Type** | Whole Blood collected in K_{2} or K_{3}EDTA | SAME |
| **Measurement Principle** | Performs hematology analyses according to the Hydro Dynamic Focusing (DC Detection), Flow cytometry method using semiconductor laser SLS-Hemoglobin Method | SAME |
| **Parameters** | **Whole Blood Mode:**
WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IRF, IPF, IPF#^{1}, RET-He
**Body Fluid Mode:**
WBC-BF, RBC-BF, MN%/#, PMN%/#, TC-BF# | SAME |
| **Reagents** | CELLPACK DCL (Diluent)
CELLPACK DST (Diluent)
CELLPACK DFL (Diluent)
Lysercell WNR (Lyse)
SULFOLYSER (Lyse)
Fluorocell WNR (Stain)
Fluorocell WDF (Stain)
Fluorocell RET (Stain)
Fluorocell PLT (Stain)
CELLCLEAN AUTO (Detergent) | SAME |
| **Controls/ Calibrators** | XN CAL (Calibrator)
XN CAL PF (Calibrator)
XN CHECK (Quality Control)
XN CHECK BF (Quality Control) | SAME |
| **Types of Analysis** | Manual analysis
Sampler analysis | SAME |
| **Analysis Modes** | Whole Blood mode
Low WBC mode
Pre-Dilution mode
Body Fluid mode | SAME |
| **Sample Aspiration/ Fluidic Pathway** | Single Pathway | SAME |
| **Measuring Channels** | WNR, WDF, RBC/PLT, RET, PLT-F | SAME |

Page 4 of 37
Classified as Confidential

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Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Item | Predicate Analyzer
XN-Series (XN-20)
K112605 | Proposed Analyzer
XR-Series (XR-10)
K250943 |
| --- | --- | --- |
| **Throughput** | Pre-Dilution mode:
Approximately 90 samples/hour

Body Fluid
40 samples/hour maximum | SAME |
| **Sample Aspiration Volumes** | Sampler Mode – 88 μL
Manual (Closed tube) Mode – 88 μL
Manual (Open tube) Mode – 88 μL
Dilution Mode – 70 μL
Body Fluid Mode – 88 μL | SAME |
| **Software Specifications** | Samples stored: 100,000 samples
Patient information: 10,000 records
Wards registered: 200 wards
Doctor names registered: 200 names
Analysis registration function: 2,000 records
QC files: 99 files per analysis module (300 plots per file)
Reagent replacement history: 5,000 records
Maintenance history: 5,000 records | SAME |
| **Differences** | | |
| **Measuring Channels** | WPC | Not Available |
| **Reagents** | Lysercell WDF (Lyse)
Lysercell WPC (Lyse)
Fluorocell WPC (Stain) | Lysercell WDF II (Lyse)
Not Available
Not Available |
| **Throughput** | Whole Blood Mode:
100 samples/hour maximum depending on mode used. | Whole Blood Mode:
110 samples/hour maximum depending on mode used. |

Please note: Intended use for the predicate analyzer was cleared in submission K112605 (XN-Series modules XN-10, XN-20). All other information listed for the predicate analyzer refers to the XN 20 module.
¹ IPF# was added to the XN-Series under K141964.

The XR-Series (XR-10) analyzer’s Indications for Use statement is similar to the predicate device with minor variation. The XR-Series (XR-10) analyzer also has similar technological characteristics to the predicate device with minor variations. Both devices measure similar parameters and utilize most of the same reagents, controls, calibrators, and cleaning detergent. The data collection software functionality, communication method with data management software functionality, monitor software, connectivity, and communication are similar to the predicate device.

In order to demonstrate that differences in technological characteristics between the subject device and predicate device do not impact safety and effectiveness, the following clinical performance studies were conducted utilizing the XR-Series (XR-10) analyzer.

Classified as Confidential

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Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

# Summary of Performance Testing:

Clinical testing was conducted on the XR-Series (XR-10) analyzer to show equivalent performance to the XN-20 analyzer. Testing included:

# Analytical Performance

# Precision (Repeatability) – Whole Blood Mode

Whole blood repeatability studies were performed to evaluate within-run imprecision of whole blood parameter results when measured in replicates of ten on Sysmex XR-Series (XR-10) analyzers at three US clinical sites. The study was conducted using residual K₂EDTA whole blood samples with concentrations targeting medical decision levels, normal and high measurement range of WBC, HGB and PLT parameters and the low, normal, and high measurement range of RBC and HCT parameters. For all other claimed parameters, testing was completed using three samples (1-3) per parameter. Testing was conducted in accordance with the CLSI EP05-A3 approved guideline. The mean, standard deviation (SD), and coefficient of variation (%CV) were calculated for each parameter. The %CV estimates were evaluated against acceptance criteria. The XR-10 met manufacturer’s specifications or predefined acceptance criteria requirements. The table below summarizes results from XR-10.

Classified as Confidential

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Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Measurand | Sample | Site | N | Range | Mean | SD | CV % |
| --- | --- | --- | --- | --- | --- | --- | --- |
| WBC (10³/μL) | MDL | 01 | 10 | 0.70-0.74 | 0.73 | 0.01 | 1.97 |
| | | 05 | 10 | 1.32-1.44 | 1.36 | 0.04 | 2.76 |
| | | 24 | 10 | 1.17-1.28 | 1.23 | 0.03 | 2.44 |
| | Normal | 01 | 10 | 4.79-5.21 | 5.02 | 0.10 | 2.09 |
| | | 05 | 10 | 5.98-6.21 | 6.13 | 0.08 | 1.29 |
| | | 24 | 10 | 7.44-7.86 | 7.63 | 0.14 | 1.89 |
| | High | 01 | 10 | 101.91-103.43 | 102.88 | 0.44 | 0.43 |
| | | 05 | 10 | 103.71-104.75 | 104.08 | 0.31 | 0.30 |
| | | 24 | 10 | 81.04-82.39 | 81.88 | 0.49 | 0.60 |
| RBC (10⁶/μL) | Low | 01 | 10 | 1.96-1.99 | 1.98 | 0.01 | 0.55 |
| | | 05 | 10 | 1.97-2.03 | 2.01 | 0.02 | 0.79 |
| | | 24 | 10 | 1.51-1.55 | 1.53 | 0.01 | 0.97 |
| | Normal | 01 | 10 | 4.04-4.15 | 4.11 | 0.03 | 0.81 |
| | | 05 | 10 | 3.84-3.90 | 3.87 | 0.02 | 0.48 |
| | | 24 | 10 | 4.69-4.85 | 4.75 | 0.05 | 0.96 |
| | High | 01 | 10 | 6.10-6.24 | 6.20 | 0.04 | 0.61 |
| | | 05 | 10 | 6.04-6.27 | 6.12 | 0.07 | 1.17 |
| | | 24 | 10 | 6.40-6.50 | 6.45 | 0.03 | 0.45 |
| HGB (g/dL) | MDL | 01 | 10 | 7.0-7.1 | 7.0 | 0.04 | 0.60 |
| | | 05 | 10 | 6.2-6.3 | 6.3 | 0.05 | 0.77 |
| | | 24 | 10 | 6.5-6.6 | 6.6 | 0.05 | 0.79 |
| | Normal | 01 | 10 | 13.1-13.3 | 13.2 | 0.06 | 0.48 |
| | | 05 | 10 | 14.7-14.9 | 14.8 | 0.06 | 0.38 |
| | | 24 | 10 | 14.3-14.6 | 14.4 | 0.11 | 0.73 |
| | High | 01 | 10 | 17.4-17.6 | 17.5 | 0.07 | 0.39 |
| | | 05 | 10 | 18.7-18.9 | 18.9 | 0.07 | 0.38 |
| | | 24 | 10 | 21.2-21.6 | 21.4 | 0.13 | 0.59 |

Classified as Confidential
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Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Measurand | Sample | Site | N | Range | Mean | SD | CV % |
| --- | --- | --- | --- | --- | --- | --- | --- |
| MCHC (g/dL) | 1 | 01 | 10 | 28.9-29.6 | 29.2 | 0.23 | 0.80 |
| | | 05 | 10 | 27.7-28.9 | 28.3 | 0.32 | 1.13 |
| | | 24 | 10 | 28.5-29.3 | 28.8 | 0.26 | 0.92 |
| | 2 | 01 | 10 | 31.3-32.2 | 31.7 | 0.28 | 0.88 |
| | | 05 | 10 | 30.4-31.4 | 30.8 | 0.31 | 1.02 |
| | | 24 | 10 | 36.6-37.6 | 37.2 | 0.28 | 0.75 |
| | 3 | 01 | 10 | 33.8-35.1 | 34.5 | 0.36 | 1.03 |
| | | 05 | 10 | 31.9-32.6 | 32.2 | 0.29 | 0.89 |
| | | 24 | 10 | 38.5-40.6 | 39.5 | 0.75 | 1.91 |
| PLT-I (10³/μL) | MDL | 01 | 10 | 25-29 | 27 | 1.10 | 4.06 |
| | | 05 | 10 | 27-33 | 30 | 1.7 | 5.62 |
| | | 24 | 10 | 19-25 | 22 | 1.81 | 8.32 |
| | Normal | 01 | 10 | 210-240 | 222 | 8.50 | 3.83 |
| | | 05 | 10 | 156-164 | 159 | 3.2 | 2.01 |
| | | 24 | 10 | 224-241 | 235 | 6.04 | 2.57 |
| | High | 01 | 10 | 885-931 | 911 | 15.62 | 1.71 |
| | | 05 | 10 | 947-992 | 969 | 12.62 | 1.30 |
| | | 24 | 10 | 754-799 | 768 | 13.69 | 1.78 |
| PLT-F (10³/μL) | MDL | 01 | 10 | 7-8 | 8 | 0.42 | 5.41 |
| | | 05 | 10 | 21-23 | 22 | 0.79 | 3.62 |
| | | 24 | 10 | 13-15 | 13 | 0.70 | 5.22 |
| | Normal | 01 | 10 | 207-225 | 217 | 6.54 | 3.01 |
| | | 05 | 10 | 167-179 | 172 | 3.03 | 1.76 |
| | | 24 | 10 | 149-155 | 152 | 1.69 | 1.11 |
| | High | 01 | 10 | 1020-1052 | 1040 | 9.19 | 0.88 |
| | | 05 | 10 | 853-886 | 875 | 10.74 | 1.23 |
| | | 24 | 10 | 871-907 | 889 | 10.10 | 1.14 |

Classified as Confidential
Page 8 of 37

{12}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Measurand | Sample | Site | N | Range | Mean | SD | CV % |
| --- | --- | --- | --- | --- | --- | --- | --- |
| RDW-SD (fL) | 1 | 01 | 10 | 42.4-43.2 | 42.7 | 0.25 | 0.59 |
| | | 05 | 10 | 43.4-44.7 | 44.0 | 0.34 | 0.78 |
| | | 24 | 10 | 40.6-42.3 | 41.4 | 0.63 | 1.52 |
| | 2 | 01 | 10 | 50.3-53.0 | 52.2 | 0.71 | 1.37 |
| | | 05 | 10 | 65.4-67.1 | 66.2 | 0.51 | 0.77 |
| | | 24 | 10 | 50.4-52.1 | 51.1 | 0.71 | 1.38 |
| | 3 | 01 | 10 | 90.2-91.7 | 90.7 | 0.48 | 0.53 |
| | | 05 | 10 | 81.6-84.5 | 83.5 | 0.87 | 1.04 |
| | | 24 | 10 | 68.5-72.5 | 70.5 | 1.13 | 1.60 |
| RDW-CV (%) | 1 | 01 | 10 | 13.0-13.2 | 13.1 | 0.06 | 0.43 |
| | | 05 | 10 | 12.9-13.2 | 13.1 | 0.10 | 0.74 |
| | | 24 | 10 | 13.2-13.4 | 13.2 | 0.07 | 0.51 |
| | 2 | 01 | 10 | 17.2-17.6 | 17.4 | 0.14 | 0.79 |
| | | 05 | 10 | 15.4-15.6 | 15.5 | 0.07 | 0.43 |
| | | 24 | 10 | 17.9-18.8 | 18.4 | 0.28 | 1.50 |
| | 3 | 01 | 10 | 22.2-22.7 | 22.5 | 0.13 | 0.59 |
| | | 05 | 10 | 20.7-21.2 | 21.0 | 0.14 | 0.65 |
| | | 24 | 10 | 23.9-24.8 | 24.3 | 0.36 | 1.46 |
| MPV (fL) | 1 | 01 | 10 | 9.1-9.5 | 9.3 | 0.13 | 1.34 |
| | | 05 | 10 | 9.1-9.2 | 9.2 | 0.05 | 0.56 |
| | | 24 | 10 | 8.8-9.0 | 8.9 | 0.07 | 0.76 |
| | 2 | 01 | 10 | 10.7-10.9 | 10.8 | 0.08 | 0.76 |
| | | 05 | 10 | 11.3-12.3 | 11.7 | 0.32 | 2.77 |
| | | 24 | 10 | 10.7-11.2 | 11.0 | 0.15 | 1.41 |
| | 3 | 01 | 10 | 14.3-14.6 | 14.5 | 0.09 | 0.66 |
| | | 05 | 9 | 13.2-14.0 | 13.7 | 0.26 | 1.91 |
| | | 24 | 10 | 11.5-12.4 | 12.0 | 0.28 | 2.35 |

Classified as Confidential
Page 9 of 37

{13}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Measurand | Sample | Site | N | Range | Mean | SD | CV % |
| --- | --- | --- | --- | --- | --- | --- | --- |
| NRBC
(10³/μL) | 1 | 01 | 10 | 0.02-0.05 | 0.04 | 0.01 | 24.28 |
| | | 05 | 10 | 0.03-0.05 | 0.04 | 0.01 | 15.06 |
| | | 24 | 10 | 0.02-0.05 | 0.04 | 0.01 | 24.28 |
| | 2 | 01 | 10 | 0.82-0.90 | 0.85 | 0.03 | 3.17 |
| | | 05 | 10 | 0.03-0.06 | 0.05 | 0.01 | 24.00 |
| | | 24 | 10 | 0.10-0.18 | 0.14 | 0.03 | 20.76 |
| | 3 | 01 | 10 | 0.25-0.35 | 0.31 | 0.03 | 11.07 |
| | | 05 | 10 | 0.96-1.03 | 0.99 | 0.02 | 2.41 |
| | | 24 | 10 | 1.28-1.35 | 1.31 | 0.02 | 1.79 |
| NRBC
(%) | 1 | 01 | 10 | 0.5-1.1 | 0.8 | 0.18 | 22.12 |
| | | 05 | 10 | 0.3-0.5 | 0.4 | 0.06 | 15.06 |
| | | 24 | 10 | 0.1-0.1 | 0.1 | 0.00 | 0.00 |
| | 2 | 01 | 10 | 1.5-1.7 | 1.6 | 0.07 | 4.30 |
| | | 05 | 10 | 0.7-1.1 | 0.8 | 0.15 | 18.92 |
| | | 24 | 10 | 0.1-0.2 | 0.2 | 0.04 | 23.42 |
| | 3 | 01 | 10 | 2.5-3.3 | 2.9 | 0.31 | 10.62 |
| | | 05 | 10 | 1.8-2.0 | 1.9 | 0.06 | 3.29 |
| | | 24 | 10 | 9.1-9.5 | 9.3 | 0.14 | 1.56 |
| NEUT
(10³/μL) | 1 | 01 | 10 | 0.34-0.43 | 0.39 | 0.03 | 7.93 |
| | | 05 | 10 | 0.49-0.57 | 0.52 | 0.02 | 4.62 |
| | | 24 | 10 | 0.55-0.66 | 0.59 | 0.04 | 6.40 |
| | 2 | 01 | 10 | 11.57-12.00 | 11.79 | 0.14 | 1.18 |
| | | 05 | 10 | 12.87-13.60 | 13.24 | 0.22 | 1.67 |
| | | 24 | 10 | 6.42-6.65 | 6.54 | 0.08 | 1.22 |
| | 3 | 01 | 10 | 88.11-90.27 | 88.92 | 0.73 | 0.82 |
| | | 05 | 10 | 92.04-95.03 | 94.09 | 1.00 | 1.06 |
| | | 24 | 10 | 52.36-54.67 | 53.58 | 0.65 | 1.21 |

Classified as Confidential
Page 10 of 37

{14}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Measurand | Sample | Site | N | Range | Mean | SD | CV % |
| --- | --- | --- | --- | --- | --- | --- | --- |
| NEUT (%) | 1 | 01 | 10 | 14.5-14.9 | 14.6 | 0.13 | 0.88 |
| | | 05 | 10 | 11.1-11.7 | 11.4 | 0.18 | 1.59 |
| | | 24 | 10 | 49.4-54.5 | 51.9 | 1.55 | 2.99 |
| | 2 | 01 | 10 | 73.8-76.4 | 75.0 | 0.92 | 1.23 |
| | | 05 | 10 | 74.2-76.8 | 75.5 | 0.89 | 1.18 |
| | | 24 | 10 | 71.3-73.9 | 72.4 | 0.77 | 1.06 |
| | 3 | 01 | 10 | 90.9-93.9 | 92.5 | 1.04 | 1.12 |
| | | 05 | 10 | 88.3-91.3 | 90.4 | 0.85 | 0.94 |
| | | 24 | 10 | 86.0-89.7 | 87.5 | 1.13 | 1.29 |
| LYMPH (10³/μL) | 1 | 01 | 10 | 0.52-0.61 | 0.55 | 0.03 | 5.04 |
| | | 05 | 10 | 0.45-0.51 | 0.49 | 0.02 | 4.19 |
| | | 24 | 10 | 0.58-0.71 | 0.64 | 0.05 | 7.13 |
| | 2 | 01 | 10 | 1.12-1.25 | 1.18 | 0.04 | 3.35 |
| | | 05 | 10 | 1.44-1.75 | 1.59 | 0.09 | 5.71 |
| | | 24 | 10 | 2.02-2.23 | 2.13 | 0.06 | 2.97 |
| | 3 | 01 | 10 | 65.70-67.84 | 66.67 | 0.77 | 1.16 |
| | | 05 | 10 | 57.42-58.32 | 57.90 | 0.30 | 0.52 |
| | | 24 | 10 | 5.35-5.74 | 5.59 | 0.12 | 2.24 |
| LYMPH (%) | 1 | 01 | 10 | 2.7-3.0 | 2.8 | 0.10 | 3.40 |
| | | 05 | 10 | 6.1-6.8 | 6.4 | 0.26 | 4.06 |
| | | 24 | 10 | 2.9-3.6 | 3.3 | 0.22 | 6.69 |
| | 2 | 01 | 10 | 11.6-13.8 | 12.5 | 0.66 | 5.25 |
| | | 05 | 10 | 38.4-40.3 | 39.4 | 0.60 | 1.53 |
| | | 24 | 10 | 26.3-29.9 | 28.0 | 1.01 | 3.61 |
| | 3 | 01 | 10 | 80.5-92.6 | 87.1 | 3.99 | 4.58 |
| | | 05 | 10 | 85.9-86.4 | 86.2 | 0.17 | 0.20 |
| | | 24 | 10 | 41.5-44.4 | 43.2 | 1.08 | 2.50 |

Classified as Confidential
Page 11 of 37

{15}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Measurand | Sample | Site | N | Range | Mean | SD | CV % |
| --- | --- | --- | --- | --- | --- | --- | --- |
| MONO (10³/μL) | 1 | 01 | 10 | 0.07-0.09 | 0.08 | 0.01 | 10.81 |
| | | 05 | 10 | 0.22-0.35 | 0.27 | 0.04 | 15.26 |
| | | 24 | 10 | 0.04-0.07 | 0.06 | 0.01 | 17.81 |
| | 2 | 01 | 10 | 0.92-1.09 | 1.01 | 0.05 | 5.31 |
| | | 05 | 10 | 0.67-0.75 | 0.71 | 0.03 | 3.73 |
| | | 24 | 10 | 0.61-0.82 | 0.71 | 0.07 | 10.09 |
| | 3 | 01 | 10 | 2.80-3.27 | 3.01 | 0.15 | 4.98 |
| | | 05 | 10 | 1.83-2.00 | 1.91 | 0.06 | 3.00 |
| | | 24 | 10 | 13.90-18.48 | 15.62 | 1.40 | 8.94 |
| MONO (%) | 1 | 01 | 10 | 2.7-3.2 | 2.9 | 0.15 | 5.24 |
| | | 05 | 10 | 1.4-2.3 | 1.8 | 0.29 | 16.14 |
| | | 24 | 10 | 4.2-7.6 | 5.1 | 1.00 | 19.61 |
| | 2 | 01 | 10 | 9.5-12.3 | 11.2 | 1.20 | 10.77 |
| | | 05 | 10 | 8.7-11.4 | 9.8 | 0.82 | 8.42 |
| | | 24 | 10 | 6.5-8.4 | 7.4 | 0.70 | 9.48 |
| | 3 | 01 | 10 | 51.2-54.8 | 53.7 | 1.00 | 1.87 |
| | | 05 | 10 | 14.8-19.3 | 17.4 | 1.41 | 8.09 |
| | | 24 | 10 | 25.0-30.2 | 27.3 | 1.83 | 6.71 |
| EO (10³/μL) | 1 | 01 | 10 | 0.08-0.12 | 0.10 | 0.01 | 12.09 |
| | | 05 | 10 | 0.12-0.16 | 0.14 | 0.01 | 7.92 |
| | | 24 | 10 | 0.09-0.15 | 0.12 | 0.02 | 20.41 |
| | 2 | 01 | 10 | 0.08-0.13 | 0.10 | 0.02 | 16.47 |
| | | 05 | 10 | 0.23-0.38 | 0.29 | 0.05 | 17.10 |
| | | 24 | 10 | 0.19-0.28 | 0.23 | 0.03 | 13.12 |
| | 3 | 01 | 10 | 0.25-0.31 | 0.28 | 0.02 | 7.98 |
| | | 05 | 10 | 1.96-2.15 | 2.03 | 0.05 | 2.67 |
| | | 24 | 10 | 0.86-1.27 | 1.10 | 0.16 | 14.18 |
| EO (%) | 1 | 01 | 10 | 1.2-2.1 | 1.5 | 0.33 | 21.58 |
| | | 05 | 10 | 0.5-0.6 | 0.6 | 0.05 | 9.22 |
| | | 24 | 10 | 0.1-0.1 | 0.1 | 0.00 | 0.00 |
| | 2 | 01 | 10 | 1.8-2.9 | 2.3 | 0.39 | 17.15 |
| | | 05 | 10 | 2.7-4.4 | 3.4 | 0.56 | 16.49 |
| | | 24 | 10 | 2.2-3.1 | 2.7 | 0.32 | 11.98 |

Page 12 of 37
Classified as Confidential

{16}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Measurand | Sample | Site | N | Range | Mean | SD | CV % |
| --- | --- | --- | --- | --- | --- | --- | --- |
| EO (%) | 3 | 01 | 10 | 6.1-10.6 | 8.0 | 1.61 | 20.06 |
| | | 05 | 10 | 5.9-7.5 | 6.8 | 0.46 | 6.85 |
| | | 24 | 10 | 3.2-5.5 | 4.4 | 0.92 | 20.99 |
| IG (10³/μL) | 1 | 01 | 10 | 0.03-0.08 | 0.06 | 0.01 | 22.56 |
| | | 05 | 10 | 0.03-0.06 | 0.04 | 0.01 | 24.43 |
| | | 24 | 10 | 0.03-0.06 | 0.05 | 0.01 | 18.89 |
| | 2 | 01 | 10 | 0.33-0.55 | 0.48 | 0.07 | 15.67 |
| | | 05 | 10 | 0.44-0.72 | 0.63 | 0.09 | 14.84 |
| | | 24 | 10 | 0.10-0.17 | 0.13 | 0.02 | 15.87 |
| | 3 | 01 | 10 | 2.81-4.55 | 3.52 | 0.61 | 17.36 |
| | | 05 | 10 | 4.79-6.21 | 5.50 | 0.37 | 6.66 |
| | | 24 | 10 | 19.32-21.21 | 20.22 | 0.61 | 3.02 |
| IG (%) | 1 | 01 | 10 | 0.7-1.8 | 1.4 | 0.33 | 22.95 |
| | | 05 | 10 | 0.5-1.0 | 0.7 | 0.16 | 24.42 |
| | | 24 | 10 | 0.4-0.7 | 0.6 | 0.08 | 15.45 |
| | 2 | 01 | 10 | 2.2-3.9 | 3.4 | 0.56 | 16.34 |
| | | 05 | 10 | 1.6-2.4 | 2.1 | 0.27 | 13.19 |
| | | 24 | 10 | 2.8-5.9 | 4.1 | 1.01 | 25.00 |
| | 3 | 01 | 10 | 9.2-11.7 | 10.2 | 0.86 | 8.42 |
| | | 05 | 10 | 9.3-12.0 | 10.7 | 0.71 | 6.62 |
| | | 24 | 10 | 23.8-25.8 | 24.7 | 0.72 | 2.90 |
| IPF (%) | 1 | 01 | 10 | 1.7-1.9 | 1.8 | 0.08 | 4.43 |
| | | 05 | 10 | 1.2-1.4 | 1.4 | 0.07 | 5.14 |
| | | 24 | 10 | 0.9-1.0 | 0.9 | 0.03 | 3.48 |
| | 2 | 01 | 10 | 4.2-4.8 | 4.5 | 0.17 | 3.86 |
| | | 05 | 10 | 6.2-6.7 | 6.4 | 0.16 | 2.57 |
| | | 24 | 10 | 3.9-4.3 | 4.1 | 0.13 | 3.15 |
| | 3 | 01 | 10 | 18.1-18.8 | 18.5 | 0.21 | 1.14 |
| | | 05 | 10 | 14.1-16.3 | 15.3 | 0.84 | 5.50 |
| | | 24 | 10 | 27.6-29.4 | 28.5 | 0.46 | 1.63 |

Classified as Confidential
Page 13 of 37

{17}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Measurand | Sample | Site | N | Range | Mean | SD | CV % |
| --- | --- | --- | --- | --- | --- | --- | --- |
| IPF (10³/μL) | 1 | 01 | 10 | 0.6-1.1 | 0.8 | 0.15 | 17.92 |
| | | 05 | 10 | 1.2-1.5 | 1.3 | 0.11 | 8.11 |
| | | 24 | 10 | 0.7-1.0 | 0.8 | 0.10 | 12.28 |
| | 2 | 01 | 10 | 10.5-12.4 | 11.2 | 0.54 | 4.83 |
| | | 05 | 10 | 6.2-7.2 | 6.7 | 0.32 | 4.80 |
| | | 24 | 10 | 13.1-14.4 | 13.8 | 0.45 | 3.26 |
| | 3 | 01 | 10 | 80.5-88.3 | 83.6 | 2.42 | 2.89 |
| | | 05 | 10 | 25.6-27.5 | 26.3 | 0.62 | 2.35 |
| | | 24 | 10 | 34.7-37.0 | 35.8 | 0.62 | 1.73 |
| RET (%) | 1 | 01 | 10 | 0.25-0.36 | 0.31 | 0.03 | 11.12 |
| | | 05 | 10 | 0.77-0.96 | 0.84 | 0.06 | 6.66 |
| | | 24 | 10 | 0.28-0.37 | 0.31 | 0.03 | 10.33 |
| | 2 | 01 | 10 | 2.67-2.97 | 2.81 | 0.10 | 3.61 |
| | | 05 | 10 | 2.23-2.44 | 2.32 | 0.07 | 2.95 |
| | | 24 | 10 | 2.43-2.74 | 2.60 | 0.11 | 4.15 |
| | 3 | 01 | 10 | 5.31-5.88 | 5.59 | 0.16 | 2.84 |
| | | 05 | 10 | 4.65-4.96 | 4.80 | 0.10 | 2.03 |
| | | 24 | 10 | 8.99-10.18 | 9.58 | 0.42 | 4.36 |
| RET (10⁶/μL) | 1 | 01 | 10 | 0.0049 - 0.0071 | 0.0061 | 0.00 | 11.36 |
| | | 05 | 10 | 0.0289 - 0.0340 | 0.0303 | 0.00 | 5.14 |
| | | 24 | 10 | 0.0068 - 0.0093 | 0.0077 | 0.00 | 10.79 |
| | 2 | 01 | 10 | 0.0913 - 0.1025 | 0.0964 | 0.00 | 3.47 |
| | | 05 | 10 | 0.0828 - 0.0921 | 0.0875 | 0.00 | 3.07 |
| | | 24 | 10 | 0.0774 - 0.0903 | 0.0829 | 0.00 | 4.49 |
| | 3 | 01 | 10 | 0.2523 - 0.2744 | 0.2597 | 0.01 | 2.94 |
| | | 05 | 10 | 0.1379 - 0.1561 | 0.1445 | 0.01 | 3.82 |
| | | 24 | 10 | 0.1694 - 0.1960 | 0.1826 | 0.01 | 3.94 |

Classified as Confidential
Page 14 of 37

{18}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Measurand | Sample | Site | N | Range | Mean | SD | CV % |
| --- | --- | --- | --- | --- | --- | --- | --- |
| IRF (%) | 1 | 01 | 10 | 4.4-6.4 | 5.4 | 0.56 | 10.26 |
| | | 05 | 10 | 2.3-3.6 | 3.0 | 0.43 | 14.23 |
| | | 24 | 10 | 3.2-5.2 | 4.5 | 0.56 | 12.57 |
| | 2 | 01 | 10 | 23.1-25.8 | 24.3 | 0.95 | 3.90 |
| | | 05 | 10 | 15.5-18.8 | 17.0 | 1.25 | 7.34 |
| | | 24 | 10 | 18.4-22.3 | 20.7 | 1.38 | 6.66 |
| | 3 | 01 | 10 | 41.2-44.6 | 42.7 | 1.17 | 2.75 |
| | | 05 | 10 | 29.9-32.4 | 31.3 | 0.91 | 2.90 |
| | | 24 | 10 | 41.8-47.0 | 43.8 | 2.00 | 4.55 |
| RET-He (pg) | 1 | 01 | 10 | 23.6-24.8 | 24.3 | 0.39 | 1.59 |
| | | 05 | 10 | 24.5-25.4 | 25.0 | 0.27 | 1.10 |
| | | 24 | 10 | 24.6-25.0 | 24.8 | 0.14 | 0.57 |
| | 2 | 01 | 10 | 33.6-33.9 | 33.7 | 0.09 | 0.28 |
| | | 05 | 10 | 33.5-34.5 | 34.1 | 0.33 | 0.97 |
| | | 24 | 10 | 33.9-35.3 | 34.7 | 0.48 | 1.39 |
| | 3 | 01 | 10 | 40.3-40.7 | 40.4 | 0.14 | 0.35 |
| | | 05 | 10 | 39.3-39.9 | 39.6 | 0.19 | 0.48 |
| | | 24 | 10 | 42.8-43.6 | 43.1 | 0.29 | 0.67 |

## Precision (Reproducibility) – Whole Blood Mode

Reproducibility studies were performed to evaluate within-run, between-run, between-day, between-site and total imprecision of whole blood parameter results when measured in the whole blood mode of Sysmex XR-Series (XR-10) analyzers. The study was conducted using 3 levels (Low, Normal and High) of XN CHECK whole blood control material. Each level of control material was run in triplicate, twice a day for 5 days (3 levels x 3 replicates x 2 runs x 5 days = 90 results). Testing was conducted by a minimum of two operators at three US clinical sites in accordance with the CLSI EP05-A3 approved guideline. The results were analyzed by analysis of variance (ANOVA) method. The XR-10 results met the acceptance criteria. The table below summarizes results from XR-10.

Classified as Confidential

{19}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| All Sites Combined | | | | Within Run | | Between Run | | Between Day | | Between Site | | Total Precision | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Parameter | Control Level | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| WBC (10³/μL) | 1 | 90 | 3.05 | 0.060 | 1.98 | 0.000 | 0.00 | 0.000 | 0.00 | 0.021 | 0.68 | 0.064 | 2.09 |
| | 2 | 90 | 6.84 | 0.083 | 1.21 | 0.024 | 0.35 | 0.012 | 0.17 | 0.055 | 0.80 | 0.103 | 1.50 |
| | 3 | 90 | 16.63 | 0.161 | 0.97 | 0.040 | 0.24 | 0.000 | 0.00 | 0.128 | 0.77 | 0.209 | 1.26 |
| RBC (10⁶/μL) | 1 | 90 | 2.32 | 0.024 | 1.03 | 0.000 | 0.00 | 0.012 | 0.51 | 0.032 | 1.36 | 0.041 | 1.78 |
| | 2 | 90 | 4.23 | 0.031 | 0.73 | 0.005 | 0.12 | 0.018 | 0.42 | 0.043 | 1.02 | 0.056 | 1.33 |
| | 3 | 90 | 4.97 | 0.037 | 0.75 | 0.017 | 0.33 | 0.000 | 0.00 | 0.032 | 0.65 | 0.052 | 1.05 |
| HGB (g/dL) | 1 | 90 | 5.2 | 0.05 | 0.98 | 0.01 | 0.22 | 0.01 | 0.20 | 0.01 | 0.17 | 0.05 | 1.04 |
| | 2 | 90 | 10.9 | 0.07 | 0.68 | 0.01 | 0.10 | 0.00 | 0.00 | 0.01 | 0.13 | 0.08 | 0.70 |
| | 3 | 90 | 14.4 | 0.06 | 0.40 | 0.01 | 0.06 | 0.02 | 0.12 | 0.06 | 0.38 | 0.08 | 0.57 |
| HCT (%) | 1 | 90 | 16.1 | 0.21 | 1.30 | 0.08 | 0.51 | 0.08 | 0.52 | 0.36 | 2.25 | 0.43 | 2.70 |
| | 2 | 90 | 33.0 | 0.29 | 0.88 | 0.19 | 0.56 | 0.13 | 0.39 | 0.62 | 1.89 | 0.72 | 2.19 |
| | 3 | 90 | 42.1 | 0.37 | 0.89 | 0.25 | 0.59 | 0.00 | 0.00 | 0.61 | 1.44 | 0.76 | 1.79 |
| MCV (fL) | 1 | 90 | 69.3 | 0.46 | 0.66 | 0.32 | 0.47 | 0.00 | 0.00 | 0.65 | 0.94 | 0.86 | 1.24 |
| | 2 | 90 | 78.0 | 0.37 | 0.47 | 0.35 | 0.45 | 0.00 | 0.00 | 0.68 | 0.87 | 0.85 | 1.09 |
| | 3 | 90 | 84.8 | 0.33 | 0.39 | 0.23 | 0.27 | 0.07 | 0.08 | 0.72 | 0.85 | 0.83 | 0.97 |

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Page 16 of 37

{20}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| All Sites Combined | | | | Within Run | | Between Run | | Between Day | | Between Site | | Total Precision | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Parameter | Control Level | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| MCH (pg) | 1 | 90 | 22.6 | 0.26 | 1.15 | 0.00 | 0.00 | 0.11 | 0.49 | 0.25 | 1.09 | 0.37 | 1.66 |
| | 2 | 90 | 25.9 | 0.20 | 0.76 | 0.02 | 0.07 | 0.11 | 0.41 | 0.29 | 1.14 | 0.37 | 1.43 |
| | 3 | 90 | 29.0 | 0.22 | 0.77 | 0.07 | 0.24 | 0.03 | 0.11 | 0.26 | 0.89 | 0.35 | 1.21 |
| MCHC (g/dL) | 1 | 90 | 32.6 | 0.47 | 1.46 | 0.08 | 0.25 | 0.15 | 0.45 | 0.67 | 2.05 | 0.84 | 2.57 |
| | 2 | 90 | 33.1 | 0.30 | 0.90 | 0.14 | 0.42 | 0.14 | 0.41 | 0.65 | 1.96 | 0.74 | 2.24 |
| | 3 | 90 | 34.2 | 0.32 | 0.92 | 0.16 | 0.48 | 0.00 | 0.00 | 0.60 | 1.74 | 0.69 | 2.03 |
| PLT-I (10³/μL) | 1 | 90 | 95 | 3.5 | 3.70 | 2.4 | 2.57 | 0.0 | 0.00 | 4.3 | 4.49 | 6.0 | 6.36 |
| | 2 | 90 | 248 | 5.1 | 2.06 | 1.8 | 0.73 | 2.9 | 1.16 | 5.7 | 2.29 | 8.3 | 3.37 |
| | 3 | 90 | 583 | 9.3 | 1.59 | 1.9 | 0.33 | 0.6 | 0.11 | 9.4 | 1.62 | 13.4 | 2.30 |
| PLT-F (10³/μL) | 1 | 90 | 89 | 1.4 | 1.58 | 0.3 | 0.35 | 0.0 | 0.00 | 4.6 | 5.24 | 4.9 | 5.48 |
| | 2 | 90 | 260 | 2.4 | 0.92 | 1.0 | 0.40 | 1.4 | 0.52 | 16.1 | 6.19 | 16.4 | 6.30 |
| | 3 | 90 | 584 | 4.7 | 0.80 | 0.7 | 0.12 | 1.3 | 0.23 | 32.0 | 5.47 | 32.4 | 5.54 |
| RDW-SD (fL) | 1 | 90 | 51.9 | 0.50 | 0.86 | 0.00 | 0.00 | 0.20 | 0.41 | 0.30 | 0.65 | 0.60 | 1.15 |
| | 2 | 90 | 46.3 | 0.33 | 0.70 | 0.08 | 0.17 | 0.00 | 0.00 | 0.73 | 1.58 | 0.80 | 1.74 |
| | 3 | 90 | 52.0 | 0.33 | 0.64 | 0.17 | 0.33 | 0.11 | 0.21 | 0.58 | 1.11 | 0.69 | 1.34 |

Classified as Confidential
Page 17 of 37

{21}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| All Sites Combined | | | | Within Run | | Between Run | | Between Day | | Between Site | | Total Precision | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Parameter | Control Level | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| RDW-CV (%) | 1 | 90 | 21.0 | 0.14 | 0.68 | 0.12 | 0.58 | 0.00 | 0.00 | 0.09 | 0.42 | 0.21 | 0.98 |
| | 2 | 90 | 16.8 | 0.11 | 0.63 | 0.06 | 0.33 | 0.00 | 0.00 | 0.14 | 0.82 | 0.18 | 1.09 |
| | 3 | 90 | 17.3 | 0.10 | 0.59 | 0.02 | 0.09 | 0.02 | 0.13 | 0.23 | 1.30 | 0.25 | 1.44 |
| MPV (fL) | 1 | 90 | 9.0 | 0.17 | 1.88 | 0.00 | 0.00 | 0.04 | 0.42 | 0.12 | 1.28 | 0.21 | 2.31 |
| | 2 | 90 | 9.3 | 0.11 | 1.16 | 0.00 | 0.00 | 0.03 | 0.36 | 0.10 | 1.13 | 0.15 | 1.66 |
| | 3 | 90 | 9.1 | 0.07 | 0.77 | 0.00 | 0.00 | 0.03 | 0.28 | 0.13 | 1.45 | 0.15 | 1.67 |
| NRBC (10³/μL) | 1 | 90 | 0.16 | 0.013 | 8.47 | 0.004 | 2.39 | 0.005 | 3.02 | 0.000 | 0.00 | 0.015 | 9.30 |
| | 2 | 90 | 0.42 | 0.020 | 4.64 | 0.000 | 0.00 | 0.007 | 1.70 | 0.000 | 0.00 | 0.021 | 4.94 |
| | 3 | 90 | 1.13 | 0.034 | 3.00 | 0.000 | 0.00 | 0.007 | 0.66 | 0.000 | 0.00 | 0.035 | 3.07 |
| NRBC (%) | 1 | 90 | 5.2 | 0.44 | 8.53 | 0.13 | 2.47 | 0.15 | 2.90 | 0.00 | 0.00 | 0.49 | 9.35 |
| | 2 | 90 | 6.2 | 0.29 | 4.70 | 0.00 | 0.00 | 0.09 | 1.40 | 0.00 | 0.00 | 0.30 | 4.90 |
| | 3 | 90 | 6.8 | 0.22 | 3.19 | 0.00 | 0.00 | 0.06 | 0.92 | 0.00 | 0.00 | 0.23 | 3.32 |
| NEUT (10³/μL) | 1 | 90 | 1.19 | 0.039 | 3.26 | 0.000 | 0.00 | 0.008 | 0.69 | 0.000 | 0.00 | 0.040 | 3.33 |
| | 2 | 90 | 3.02 | 0.068 | 2.23 | 0.014 | 0.48 | 0.000 | 0.00 | 0.031 | 1.01 | 0.075 | 2.50 |
| | 3 | 90 | 7.95 | 0.163 | 2.05 | 0.063 | 0.80 | 0.000 | 0.00 | 0.065 | 0.82 | 0.186 | 2.34 |

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Page 18 of 37

{22}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| All Sites Combined | | | | Within Run | | Between Run | | Between Day | | Between Site | | Total Precision | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Parameter | Control Level | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| LYMPH
(10³/μL) | 1 | 90 | 1.17 | 0.037 | 3.13 | 0.000 | 0.00 | 0.006 | 0.49 | 0.011 | 0.90 | 0.039 | 3.29 |
| | 2 | 90 | 2.15 | 0.058 | 2.68 | 0.014 | 0.66 | 0.000 | 0.00 | 0.018 | 0.86 | 0.062 | 2.89 |
| | 3 | 90 | 4.42 | 0.080 | 1.82 | 0.000 | 0.00 | 0.000 | 0.00 | 0.036 | 0.81 | 0.088 | 1.99 |
| MONO
(10³/μL) | 1 | 90 | 0.26 | 0.016 | 6.33 | 0.000 | 0.00 | 0.000 | 0.00 | 0.000 | 0.00 | 0.016 | 6.33 |
| | 2 | 90 | 0.63 | 0.031 | 4.88 | 0.000 | 0.00 | 0.005 | 0.83 | 0.003 | 0.53 | 0.031 | 4.98 |
| | 3 | 90 | 1.56 | 0.050 | 3.22 | 0.000 | 0.00 | 0.027 | 1.74 | 0.000 | 0.00 | 0.057 | 3.66 |
| EO
(10³/μL) | 1 | 90 | 0.29 | 0.027 | 9.47 | 0.000 | 0.00 | 0.000 | 0.00 | 0.001 | 0.32 | 0.027 | 9.48 |
| | 2 | 90 | 0.72 | 0.058 | 8.01 | 0.000 | 0.00 | 0.003 | 0.39 | 0.016 | 2.20 | 0.060 | 8.32 |
| | 3 | 90 | 1.89 | 0.112 | 5.92 | 0.045 | 2.40 | 0.042 | 2.22 | 0.026 | 1.37 | 0.131 | 6.90 |
| BASO
(10³/μL) | 1 | 90 | 0.14 | 0.007 | 4.59 | 0.000 | 0.00 | 0.001 | 0.97 | 0.000 | 0.00 | 0.007 | 4.70 |
| | 2 | 90 | 0.33 | 0.010 | 3.17 | 0.000 | 0.00 | 0.003 | 0.88 | 0.003 | 1.01 | 0.011 | 3.44 |
| | 3 | 90 | 0.80 | 0.019 | 2.43 | 0.000 | 0.00 | 0.000 | 0.00 | 0.008 | 0.94 | 0.021 | 2.60 |
| NEUT
(%) | 1 | 90 | 39.0 | 0.96 | 2.47 | 0.00 | 0.00 | 0.25 | 0.64 | 0.00 | 0.00 | 1.00 | 2.55 |
| | 2 | 90 | 44.2 | 0.85 | 1.93 | 0.00 | 0.00 | 0.00 | 0.00 | 0.13 | 0.29 | 0.86 | 1.96 |
| | 3 | 90 | 47.8 | 0.82 | 1.71 | 0.30 | 0.64 | 0.00 | 0.00 | 0.04 | 0.09 | 0.88 | 1.83 |

Classified as Confidential
Page 19 of 37

{23}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| All Sites Combined | | | | Within Run | | Between Run | | Between Day | | Between Site | | Total Precision | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Parameter | Control Level | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| LYMPH (%) | 1 | 90 | 38.5 | 1.02 | 2.66 | 0.00 | 0.00 | 0.20 | 0.53 | 0.00 | 0.00 | 1.04 | 2.71 |
| | 2 | 90 | 31.4 | 0.78 | 2.48 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.78 | 2.48 |
| | 3 | 90 | 26.6 | 0.38 | 1.42 | 0.02 | 0.09 | 0.00 | 0.00 | 0.06 | 0.24 | 0.38 | 1.44 |
| MONO (%) | 1 | 90 | 8.4 | 0.51 | 6.05 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.51 | 6.05 |
| | 2 | 90 | 9.1 | 0.42 | 4.57 | 0.00 | 0.00 | 0.03 | 0.32 | 0.00 | 0.00 | 0.42 | 4.58 |
| | 3 | 90 | 9.4 | 0.30 | 3.24 | 0.02 | 0.17 | 0.15 | 1.58 | 0.00 | 0.00 | 0.34 | 3.61 |
| EO (%) | 1 | 90 | 9.4 | 0.86 | 9.17 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.86 | 9.17 |
| | 2 | 90 | 10.5 | 0.83 | 7.93 | 0.00 | 0.00 | 0.10 | 0.96 | 0.25 | 2.39 | 0.88 | 8.34 |
| | 3 | 90 | 11.4 | 0.68 | 5.95 | 0.27 | 2.35 | 0.24 | 2.09 | 0.08 | 0.74 | 0.77 | 6.77 |
| BASO (%) | 1 | 90 | 4.7 | 0.20 | 4.15 | 0.00 | 0.00 | 0.04 | 0.94 | 0.02 | 0.33 | 0.20 | 4.27 |
| | 2 | 90 | 4.8 | 0.14 | 2.90 | 0.00 | 0.00 | 0.04 | 0.83 | 0.00 | 0.00 | 0.15 | 3.02 |
| | 3 | 90 | 4.8 | 0.10 | 2.15 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.10 | 2.15 |
| IG (10³/μL) | 1 | 90 | 0.30 | 0.011 | 3.67 | 0.000 | 0.00 | 0.003 | 0.90 | 0.000 | 0.00 | 0.011 | 3.77 |
| | 2 | 90 | 0.77 | 0.026 | 3.43 | 0.005 | 0.66 | 0.000 | 0.00 | 0.006 | 0.77 | 0.027 | 3.57 |
| | 3 | 90 | 2.00 | 0.056 | 2.82 | 0.000 | 0.00 | 0.016 | 0.79 | 0.000 | 0.00 | 0.058 | 2.93 |

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Page 20 of 37

{24}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| All Sites Combined | | | | Within Run | | Between Run | | Between Day | | Between Site | | Total Precision | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Parameter | Control Level | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| IG (%) | 1 | 90 | 9.9 | 0.33 | 3.35 | 0.00 | 0.00 | 0.06 | 0.57 | 0.00 | 0.00 | 0.34 | 3.40 |
| | 2 | 90 | 11.2 | 0.34 | 3.04 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.34 | 3.04 |
| | 3 | 90 | 12.0 | 0.30 | 2.50 | 0.00 | 0.00 | 0.11 | 0.91 | 0.00 | 0.00 | 0.32 | 2.66 |
| RET (%) | 1 | 90 | 5.56 | 0.134 | 2.42 | 0.000 | 0.00 | 0.053 | 0.94 | 0.232 | 4.17 | 0.273 | 4.91 |
| | 2 | 90 | 2.35 | 0.075 | 3.21 | 0.011 | 0.48 | 0.000 | 0.00 | 0.095 | 4.02 | 0.122 | 5.17 |
| | 3 | 90 | 1.26 | 0.051 | 4.07 | 0.000 | 0.00 | 0.013 | 1.04 | 0.042 | 3.34 | 0.068 | 5.37 |
| RET (10^{6}/μL) | 1 | 90 | 0.1289 | 0.00340 | 2.64 | 0.00000 | 0.00 | 0.00118 | 0.91 | 0.00359 | 2.78 | 0.00509 | 3.95 |
| | 2 | 90 | 0.0994 | 0.00322 | 3.24 | 0.00069 | 0.69 | 0.00000 | 0.00 | 0.00322 | 3.23 | 0.00460 | 4.63 |
| | 3 | 90 | 0.0627 | 0.00260 | 4.14 | 0.00000 | 0.00 | 0.00075 | 1.19 | 0.00221 | 3.53 | 0.00349 | 5.57 |
| IRF (%) | 1 | 90 | 33.5 | 2.38 | 7.10 | 2.00 | 5.98 | 0.00 | 0.00 | 0.70 | 2.09 | 3.19 | 9.51 |
| | 2 | 90 | 40.3 | 2.21 | 5.49 | 1.55 | 3.85 | 0.00 | 0.00 | 0.72 | 1.78 | 2.80 | 6.94 |
| | 3 | 90 | 33.7 | 1.94 | 5.76 | 0.41 | 1.20 | 0.41 | 1.23 | 0.24 | 0.71 | 2.04 | 6.05 |
| RET-He (pg) | 1 | 90 | 24.0 | 0.14 | 0.59 | 0.14 | 0.58 | 0.06 | 0.25 | 0.11 | 0.47 | 0.24 | 0.99 |
| | 2 | 90 | 24.8 | 0.17 | 0.69 | 0.08 | 0.32 | 0.07 | 0.26 | 0.18 | 0.74 | 0.27 | 1.10 |
| | 3 | 90 | 25.8 | 0.25 | 0.98 | 0.00 | 0.00 | 0.06 | 0.25 | 0.23 | 0.90 | 0.35 | 1.35 |
| IPF (%) | 1 | 90 | 19.1 | 0.53 | 2.75 | 0.22 | 1.13 | 0.00 | 0.00 | 0.02 | 0.13 | 0.57 | 2.98 |
| | 2 | 90 | 19.8 | 0.65 | 3.29 | 0.00 | 0.00 | 0.00 | 0.00 | 0.28 | 1.41 | 0.71 | 3.58 |
| | 3 | 90 | 20.0 | 0.76 | 3.82 | 0.00 | 0.00 | 0.36 | 1.78 | 0.28 | 1.38 | 0.88 | 4.43 |
| IPF (10^{3}/μL) | 1 | 90 | 16.9 | 0.51 | 3.04 | 0.23 | 1.37 | 0.00 | 0.00 | 0.86 | 5.10 | 1.03 | 6.10 |
| | 2 | 90 | 51.5 | 1.80 | 3.49 | 0.00 | 0.00 | 0.40 | 0.77 | 2.87 | 5.56 | 3.41 | 6.61 |
| | 3 | 90 | 116.6 | 4.59 | 3.93 | 0.00 | 0.00 | 2.01 | 1.72 | 7.95 | 6.81 | 9.39 | 8.05 |

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{25}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

# Precision (Repeatability) – Body Fluid Mode

Body fluid repeatability studies were conducted using residual peritoneal, pleural and synovial fluid samples collected in K₂EDTA anticoagulant and CSF without anticoagulant with concentrations targeting the low, and high end of the measurement range of direct measured parameters (WBC-BF, RBC-BF, TC-BF). Each sample was thoroughly mixed by gentle hand inversion and measured in replicates of ten in the body fluid mode on XR-10 analyzer at three US clinical sites. Testing was conducted in accordance with the CLSI EP05-A3 approved guideline. The mean, standard deviation (SD), and coefficient of variation (%CV) were calculated for each parameter. The %CV estimates were evaluated against acceptance criteria. The calculated coefficient of variation (%CV) of all body fluid parameters on XR-10 analyzer across all sites met manufacturer’s specifications.

# Precision (Reproducibility) – Body Fluid Mode

Reproducibility studies were performed to evaluate within-run, between-run, between-day, between-site and total imprecision of body fluid parameter results when measured in the body fluid mode of Sysmex XR-Series (XR-10) analyzer. The study was conducted using 2 levels (Low and High) of XN CHECK BF body fluid control material. Testing was conducted by a minimum of two operators at three US clinical sites in accordance with the CLSI EP05-A3 approved guideline. Each level of control was mixed thoroughly prior to sampling in triplicate, twice a day for 5 days (2 levels x 3 replicates x 2 runs x 5 days = 60 results per parameter) in the body fluid analysis mode on XR-10 analyzer at each site. The results were analyzed by analysis of variance (ANOVA) method. The XR-10 results met manufacturer’s specifications. The table below summarizes results from XR-10.

Classified as Confidential

{26}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| All Sites Combined | | | | Within Run | | Between Run | | Between Day | | Between Site | | Total Precision | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Parameter | Control Level | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | %SD | %CV |
| WBC-BF (10^{3}/μL) | 1 | 90 | 0.073 | 0.0029 | 3.91 | 0.0009 | 1.18 | 0.0000 | 0.00 | 0.0006 | 0.82 | 0.0030 | 4.16 |
| | 2 | 90 | 0.303 | 0.0061 | 2.01 | 0.0000 | 0.00 | 0.0016 | 0.54 | 0.0032 | 1.07 | 0.0071 | 2.34 |
| RBC-BF (10^{6}/μL) | 1 | 90 | 0.024 | 0.0008 | 3.49 | 0.0000 | 0.00 | 0.0002 | 0.86 | 0.0004 | 1.57 | 0.0009 | 3.93 |
| | 2 | 90 | 0.073 | 0.0014 | 1.87 | 0.0000 | 0.00 | 0.0004 | 0.53 | 0.0011 | 1.51 | 0.0018 | 2.46 |
| MN (10^{3}/μL) | 1 | 90 | 0.021 | 0.0016 | 7.33 | 0.0003 | 1.38 | 0.0000 | 0.00 | 0.0001 | 0.49 | 0.0016 | 7.47 |
| | 2 | 90 | 0.088 | 0.0032 | 3.61 | 0.0000 | 0.00 | 0.0008 | 0.90 | 0.0011 | 1.23 | 0.0035 | 3.92 |
| MN % (%) | 1 | 90 | 29.1 | 1.74 | 5.98 | 0.34 | 1.17 | 0.00 | 0.00 | 0.28 | 0.97 | 1.80 | 6.17 |
| | 2 | 90 | 29.1 | 0.90 | 3.08 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.90 | 3.08 |
| PMN (10^{3}/μL) | 1 | 90 | 0.052 | 0.0023 | 4.50 | 0.0007 | 1.41 | 0.0000 | 0.00 | 0.0006 | 1.16 | 0.0025 | 4.86 |
| | 2 | 90 | 0.215 | 0.0052 | 2.40 | 0.0000 | 0.00 | 0.0000 | 0.00 | 0.0021 | 0.97 | 0.0056 | 2.59 |
| PMN (%) | 1 | 90 | 70.9 | 1.74 | 2.45 | 0.34 | 0.48 | 0.00 | 0.00 | 0.28 | 0.40 | 1.80 | 2.53 |
| | 2 | 90 | 70.9 | 0.90 | 1.26 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.90 | 1.26 |
| TC-BF (10^{3}/μL) | 1 | 90 | 0.073 | 0.0029 | 3.91 | 0.0009 | 1.18 | 0.0000 | 0.00 | 0.0006 | 0.82 | 0.0030 | 4.16 |
| | 2 | 90 | 0.303 | 0.0061 | 2.01 | 0.0000 | 0.00 | 0.0016 | 0.54 | 0.0032 | 1.07 | 0.0071 | 2.34 |

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Page 23 of 37

{27}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

Linearity:

Whole Blood

Linearity studies were performed using WRP CHECK EX whole blood linearity material and system diluent (CELLPACK DCL). A minimum of seven sample dilutions were created with concentrations which span the full measurement range (1-level below, 5-levels within and 1-level above) of WBC, RBC, HGB, HCT, PLT-I and PLT-F directly measured parameters. All samples were mixed thoroughly prior to testing in replicates of three in the whole blood mode of three XR-10 analyzers at one internal site. Testing and analysis of the data were conducted in accordance with CLSI EP06-ED2:2020. The results of whole blood linearity for measured WBC, RBC, HGB, HCT, PLT-I and PLT-F parameters by XR-10 analyzers demonstrate the method to be linear from the lower limit to upper limit and within the measured maximum allowable deviation from linearity for each interval. All results met predefined acceptance criteria.

| Parameter | Linear Range |
| --- | --- |
| WBC (x10³/μL) | 0.03 – 440.00 |
| RBC (x10⁶/μL) | 0.01 – 8.60 |
| HGB (g/dL) | 0.1 – 26.0 |
| HCT (%) | 0.1 – 75.0 |
| PLT(x10³/μL) | 2 – 5,000 |
| RET (%) | 0.00 – 30.00 |

Body Fluid

Linearity studies were performed using a minimum of seven sample dilutions created with concentrations which spanned the full measurement range (1-level below, 5-levels within and 1-level above) of WBC-BF, RBC-BF and TC-BF direct measured parameters. All samples were mixed thoroughly prior to testing in replicates of three in the body fluid mode of three XR-10 analyzers at one internal site. Testing and analysis of the data were conducted in accordance with CLSI EP06-ED2:2020. The results of body fluid linearity for measured WBC-BF, RBC-BF and TC-BF parameters by XR-10 demonstrate the method to be linear from the lower limit to upper limit and is within the measured maximum allowable deviation from linearity for each interval. All results met predefined acceptance criteria.

| Parameter | Linear Range |
| --- | --- |
| WBC-BF (x10³/μL) | 0.003 – 10.000 |
| RBC-BF (x10⁶/μL) | 0.002 – 5.000 |
| TC-BF (x10³/μL) | 0.003 – 10.000 |

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{28}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

# Analytical Specificity/Interferences:

Interfering substances studies were conducted for Bilirubin F, Bilirubin C, Chyle, Hemolytic Hemoglobin, Lipids, and high WBC, RBC, and platelet counts and microcytic RBCs to determine the concentration that impact all claimed parameters on the Sysmex XR-Series Automated Hematology analyzers. Whole blood K₂EDTA samples were collected from donors for this study and varying concentrations of interferent was added to obtain concentrations. The tubes were mixed, and measurements were repeated in four consecutive batches on the XR-Series automated hematology analyzer. The following table includes the results of the study:

| Interferent | Conclusion |
| --- | --- |
| Bilirubin F | There was no significant Bilirubin F interference up to a concentration of 40 mg/dL for all parameters. |
| Bilirubin C | There was no significant Bilirubin C interference up to a concentration of 40 mg/dL for all parameters. |
| Chyle | There was no significant Chyle interference up to a concentration of 3,600 FTU for all parameters except for the MCHC parameter. For the MCHC parameter, there was no significant interference up to a concentration of 2,880 FTU. |
| Hemolytic Hemoglobin | There was no significant Hemolysis interference up to a concentration of 1,000 mg/dL for all parameters except for MCH, MCHC. For the MCH parameter, there was no significant interference observed up to a concentration of 800mg/dL. For the MCHC parameter, no significant interference was observed up to a concentration of 400mg/dL. |
| Lipids | There was no significant Lipemia (Intralipos) interference up to a concentration of 2.00 g/dL for all parameters except for HGB, MCH, and MCHC parameters. For HGB and MCH parameters, there was no significant interference up to a concentration of 0.20 g/dL. For the MCHC parameter, there was no significant interference up to a concentration of 0.10 g/dL. |
| High white blood cell counts | There was no significant WBC interference up to a concentration of 360.63 x 10³ cells/μL for all parameters. |
| High red blood cell counts | There was no significant RBC interference observed up to a concentration of 8.04 x 10⁶ cells/μL for all parameters. |
| High platelet counts | There was no significant PLT interference observed up to a concentration of 1513 (PLT-I) or 1563 (PLT-F) x 10³ cells/μL for all parameters. |
| Microcytic RBCs | There was no significant interference from microcytic RBCs observed for RBC, HCT or PLT (I/F) parameters with MCV values ≤70 fL. |

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{29}

Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

# Sample Stability:

## Whole Blood Stability

The evaluation of whole blood stability was conducted at one internal site using normal and abnormal (8 unique leftover samples and 12 prospectively collected) de-identified K₂EDTA venous whole blood samples. Samples were split into two sets stored at room temperature (18-26°C) and refrigerated temperature (2-8°C). Samples were tested in duplicate at baseline (T0), 6, 24, 25, 48, 49, 72 and 73 hours at both conditions. The mean, standard deviation, mean difference and percent difference from the baseline mean of each sample result were calculated for each parameter at each time interval for both conditions. The data supports a whole blood sample stability of 24 hours at room temperature (18-26°C) and 48 hours at refrigerated temperature (2-8°C) for XR-Series (XR-10) claimed whole blood parameters.

## Body Fluid Short-term Stability

The evaluation of body fluid stability was conducted at 1 external site using 12 unique de-identified leftover body fluid samples (3-CSF, 3-peritioneal, 3-pleural and 3-synovial) when stored at controlled room temperature (RT). Peritoneal, pleural and synovial body fluid samples collected in K₂EDTA anticoagulant and CSF without anticoagulant. Samples were thoroughly mixed by gentle hand inversion at least ten times, before analyzing in singlet on XR-10 analyzer. Samples were tested at baseline or zero (0) time, 1, 2, and 4 hours at RT (18-26°C) in the body fluid analysis mode.

Body fluid samples should be analyzed within 1 hour of collection on the XR-Series (XR-10) analyzer as demonstrated in the short term stability study.

# Detection Limit:

## Whole Blood Mode

Limits of Blank (LoB), Limit of Detection (LoD), and the Limit of Quantitation (LoQ) were determined for the direct measured WBC, RBC, HGB, HCT and PLT parameters on Sysmex XR-10 Automated Hematology Analyzers.

In LoB testing, four blank samples were measured in replicates of five, over a period of three days using two reagent lots, to yield 120 total measurement results per parameter. To determine the LoD and LoQ, four low concentration samples were analyzed on the Sysmex XN-20 automated hematology analyzer (K112605) to assign the reference value. The low-level samples were then measured in replicates of five over a period of three days using two reagent lots, to yield 120 total measurement results per parameter across 2-XR-10 (4 samples x 5 replicates x 3 days x 1 reagent lot per analyzer = 60 results per analyzer).

The results of the LoB, LoD, and LoQ are provided in the table below.

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XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Parameter (Unit) | Limit of Blank (LoB) | Limit of Detection (LoD) | Limit of Quantitation (LoQ) |
| --- | --- | --- | --- |
| WBC (x 10³/μL) | 0.00 | 0.01 | 0.02 |
| RBC (x 10⁶/μL) | 0.00 | 0.01 | 0.01 |
| HGB (g/dL) | 0.0 | 0.1 | 0.1 |
| HCT (%) | 0.0 | 0.1 | 0.1 |
| PLT-I (x 10³/μL) | 0 | 1 | 2 |
| PLT-F (x 10³/μL) | 0 | 1 | 2 |

# Body Fluid Mode

Limits of Blank (LoB), Limit of Detection (LoD), and the Limit of Quantitation (LoQ) were determined for the direct measured WBC-BF, RBC-BF and TC-BF parameters on Sysmex XR-10 Automated Hematology Analyzers.

In LoB testing, four blank samples were measured in replicates of five, over a period of three days using two reagent lots, to yield 120 total measurement results per parameter. To determine the LoD and LoQ, four low concentration samples were analyzed on the Sysmex XN-20 automated hematology analyzer (K112605) to assign the reference value. The low-level samples were then measured in replicates of five over a period of three days using two reagent lots, to yield 120 total measurement results per parameter across 2-XR-10 (4 samples x 5 replicates x 3 days x 1 reagent lot per analyzer = 60 results per analyzer).

The results of the LoB, LoD, and LoQ are provided in the table below.

| Parameter | LoB (N=120) | LoD (N=120) | LoQ (N=120) |
| --- | --- | --- | --- |
| WBC-BF (10³/μL) | 0.001 | 0.002 | 0.002 |
| RBC-BF (10⁶/μL) | 0.000 | 0.002 | 0.002 |
| TC-BF (10³/μL) | 0.001 | 0.002 | 0.002 |

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Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

# Carry-Over:

## Whole Blood

Three sets of carryover sequences were run on Sysmex XR-10 analyzers for each applicable parameter at three US clinical sites using de-identified leftover venous whole blood samples collected in K₂EDTA anticoagulant. For each parameter, high target concentration samples were run in replicates of three (H1, H2, H3) followed by three replicates of low target concentration samples (L1, L2, L3) in XR-10 whole blood mode. The study was conducted in accordance with CLSI H26-A2. The results of the whole blood carryover on XR-10 analyzers show all applicable parameters met the manufacturer's specifications.

## Body Fluid

Carryover was conducted using de-identified peritoneal, pleural and synovial fluids collected in K₂EDTA and CSF samples without anticoagulant with high target and low target WBC-BF, RBC-BF, and TC-BF. Three sets of carryover sequences were run on Sysmex XR-10 analyzers for each applicable parameter at three US clinical sites using de-identified leftover peritoneal, pleural and synovial fluid samples collected in K₂EDTA anticoagulant and CSF without anticoagulant. For each parameter, high target concentration samples were run in replicates of three (H1, H2, H3) followed by three replicates of low target concentration samples (L1, L2, L3) in XR-Series body fluid mode. The study was conducted in accordance with CLSI H26-A2. The results of body fluid carryover on XR-10 analyzers show all applicable parameters met the manufacturer's specifications.

# Comparison Studies:

## Whole Blood - Method Comparison with Predicate Device

A method comparison study was conducted to assess the performance of the Sysmex XR-Series (XR-10) Automated Hematology analyzers compared to the predicate device, Sysmex XN-20 (K112605). A total of 865 unique residual whole blood samples in K₂EDTA anticoagulant from pediatrics (<21 years) and adult (≥21 years) subjects including a variety of disease states (e.g., pathological WBCs, lipemia, hyperbilirubinemia, hemoglobinopathies, thrombocytopenia, thrombocytosis, etc.) were tested across 3 US clinical sites. Twenty samples were excluded due to insufficient sample volume and operator error.

Sample demographics from all sites included 310 pediatric subjects and 551 adults and 4 subjects with age not reported. Of this total, 53.7% were male, 45.8% female and 0.5% with sex not reported. A total of 362 normal (no flags, marked as negative) whole blood samples and 500 abnormal whole blood samples (contained flags, marked as positive) were tested.

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XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

The results of the linear regression and bias analyses between the XR-10 Whole Blood Mode and XN-20 met the acceptance criteria for all applicable parameters for correlation coefficient (r) and %Bias with the exception of the calculated bias for HGB on XR-10 at one site. The bias (-2.10%, -0.3 g/dL) was slightly above the predefined bias limits (±2% or 0.2g/dL) but is well within the predefined correlation and coefficient value limits of ≥0.95 (0.9932) and is determined acceptable. An example of the results between XN-20 and XR-10 is shown below.

Correlation and Estimated Bias (Whole Blood – Combined Sites) – XN-20 vs XR-10

| Measurand | N | Result Range | r | Slope (95% CI) | Intercept (95% CI) | Mean Diff. | Mean %Diff. |
| --- | --- | --- | --- | --- | --- | --- | --- |
| WBC (10³/μL) | 841 | 0.03 - 410.88 | 0.9997 | 1.002 (0.993, 1.010) | 0.066 (-0.031, 0.163) | 0.09 | 0.52 |
| RBC (10⁶/μL) | 845 | 0.03 - 8.50 | 0.9900 | 1.000 (0.991, 1.009) | -0.035 (-0.075, 0.005) | -0.03 | -0.83 |
| HGB (g/dL) | 843 | 0.2 - 25.6 | 0.9915 | 0.994 (0.986, 1.002) | -0.100 (-0.213, 0.013) | -0.2 | -1.41 |
| HCT (%) | 842 | 0.3 - 75.0 | 0.9901 | 0.999 (0.989, 1.009) | -0.338 (-0.743, 0.067) | -0.4 | -0.98 |
| MCV (fL) | 845 | 62.7 - 141.5 | 0.9922 | 0.980 (0.971, 0.989) | 1.711 (0.881, 2.540) | -0.2 | -0.19 |
| MCH (pg) | 844 | 17.2 - 46.6 | 0.9778 | 0.995 (0.973, 1.017) | -0.006 (-0.650, 0.637) | -0.2 | -0.54 |
| MCHC (g/dL) | 844 | 22.2 - 41.6 | 0.9286 | 0.961 (0.921, 1.002) | 1.104 (-0.181, 2.390) | -0.1 | -0.38 |
| PLT-I (10³/μL) | 842 | 3 - 4930 | 0.9991 | 0.989 (0.977, 1.001) | 0.840 (-2.580, 4.260) | -3.0 | -0.81 |
| PLT-F (10³/μL) | 824 | 4 - 4748 | 0.9987 | 1.017 (0.999, 1.035) | 0.393 (-4.754, 5.540) | 6.0 | 1.81 |
| RDW-SD (fL) | 840 | 29.8 - 121.5 | 0.9959 | 0.965 (0.953, 0.977) | 1.891 (1.306, 2.476) | 0.1 | 0.12 |

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XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Measurand | N | Result Range | r | Slope (95% CI) | Intercept (95% CI) | Mean Diff. | Mean %Diff. |
| --- | --- | --- | --- | --- | --- | --- | --- |
| RDW-CV (%) | 841 | 10.4 - 34.8 | 0.9947 | 0.985
(0.974, 0.995) | 0.229
(0.078, 0.380) | -0.0 | -0.06 |
| MPV (fL) | 780 | 8.1 - 14.7 | 0.9338 | 0.972
(0.944, 0.999) | 0.085
(-0.204, 0.374) | -0.2 | -2.04 |
| NRBC (10³/μL) | 843 | 0 - 11.95 | 0.9994 | 1.001
(0.988, 1.014) | -0.000
(-0.002, 0.002) | 0.00 | 0.00 |
| NRBC (%) | 843 | 0 - 114.3 | 0.9991 | 0.969
(0.937, 1.000) | 0.026
(0.006, 0.047) | -0.0 | -0.47 |
| NEUT (10³/μL) | 834 | 0 - 300.11 | 0.9957 | 0.999
(0.960, 1.038) | 0.063
(-0.206, 0.332) | 0.05 | 0.52 |
| LYMPH (10³/μL) | 834 | 0 - 389.35 | 0.9985 | 1.026
(0.988, 1.065) | 0.120
(-0.017, 0.256) | 0.24 | 5.19 |
| MONO (10³/μL) | 834 | 0 - 71.69 | 0.9692 | 0.939
(0.823, 1.056) | -0.001
(-0.128, 0.126) | -0.11 | -6.15 |
| EO (10³/μL) | 833 | 0.00 - 8.11 | 0.9760 | 1.036
(0.938, 1.134) | -0.004
(-0.021, 0.014) | 0.01 | 2.09 |
| BASO (10³/μL) | 834 | 0 - 30.10 | 0.9832 | 0.836
(0.670, 1.001) | 0.009
(-0.013, 0.031) | -0.04 | -15.07 |
| NEUT (%) | 834 | 0 - 96.3 | 0.9925 | 1.001
(0.992, 1.010) | -0.077
(-0.676, 0.521) | -0.0 | -0.03 |
| LYMPH (%) | 834 | 0 - 96.7 | 0.9938 | 1.013
(1.003, 1.023) | 0.188
(-0.057, 0.433) | 0.6 | 2.01 |
| MONO (%) | 834 | 0 - 79.6 | 0.9658 | 0.940
(0.898, 0.981) | 0.148
(-0.201, 0.496) | -0.4 | -4.50 |
| EO (%) | 833 | 0.0 - 47.5 | 0.9897 | 1.001
(0.970, 1.031) | 0.028
(-0.030, 0.085) | 0.0 | 1.33 |
| BASO (%) | 834 | 0 - 8.4 | 0.9417 | 0.865
(0.796, 0.935) | 0.014
(-0.027, 0.055) | -0.1 | -11.55 |
| IG (10³/μL) | 834 | 0 - 155.97 | 0.9980 | 0.995
(0.967, 1.023) | -0.000
(-0.033, 0.033) | -0.01 | -0.42 |
| IG (%) | 834 | 0 - 44.8 | 0.9599 | 0.977
(0.936, 1.018) | 0.016
(-0.057, 0.090) | -0.0 | -0.26 |

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Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Measurand | N | Result Range | r | Slope (95% CI) | Intercept (95% CI) | Mean Diff. | Mean %Diff. |
| --- | --- | --- | --- | --- | --- | --- | --- |
| RET (%) | 824 | 0.12 - 23.10 | 0.9839 | 0.997 (0.959, 1.035) | 0.031 (-0.036, 0.098) | 0.02 | 1.06 |
| RET (10^{6}/μL) | 793 | 0.01 - 0.5460 | 0.9727 | 0.978 (0.913, 1.042) | 0.002 (-0.003, 0.007) | 0.0004 | 0.40 |
| IRF (%) | 824 | 0 - 56.7 | 0.9729 | 0.976 (0.955, 0.997) | -1.660 (-1.927, -1.392) | -2.1 | -12.62 |
| RET-He (pg) | 822 | 17 - 51.3 | 0.9689 | 0.923 (0.902, 0.944) | 1.294 (0.619, 1.969) | -1.2 | -3.68 |
| IPF (%) | 824 | 0.4 - 37.9 | 0.9891 | 0.983 (0.958, 1.009) | -0.072 (-0.175, 0.031) | -0.2 | -3.12 |
| IPF (10^{3}/μL) | 819 | 0.2 - 256.4 | 0.9876 | 1.036 (0.950, 1.123) | -0.666 (-1.632, 0.300) | -0.2 | -1.46 |

## Body Fluid - Method Comparison with Predicate Device

A method comparison study was conducted to assess the performance of Sysmex XR-10 Body Fluid Mode when compared to the predicate device, Sysmex XN-20 (K112605). A total of 397 residual body fluid samples at three US sites. Two samples were excluded due to insufficient sample volume. All body fluids (peritoneal, pleural, and synovial) were collected in $\mathrm{K}_2\mathrm{EDTA}$ anticoagulant with exception of CSF. All Samples were run in the Body Fluid Mode in singlet on the XN-20 and within two hours on the XR-10 analyzer. Samples covered clinical medical decision levels, and to the extent possible, of the full measuring ranges of the XR-Series analyzers. The results of the linear regression and bias analyses between XR-10, and XN-20 Body Fluid Mode for all body fluids (CSF, peritoneal, pleural and synovial) are shown below.

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Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Fluid Type | Measurand | N | Result Range | R | Slope (95% CI) | Intercept (95% CI) | Mean Diff. | % Mean Diff. Or SD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| CSF | WBC-BF (10^{3}/µL) | 76 | 0.003 - 9.178 | 0.9968 | 0.996 (0.966, 1.027) | 0.001 (-0.025, 0.028) | -0.008 | -0.31 |
| | RBC-BF (10^{6}/µL) | 61 | 0.002 - 4.875 | 0.9970 | 0.997 (0.986, 1.008) | 0.023 (-0.020, 0.066) | 0.019 | 1.29 |
| | MN (10^{3}/µL) | 70 | 0.003 - 4.074 | 0.8750 | 1.734 (0.729, 2.738) | -0.459 (-1.198, 0.280) | 0.244 | 1 SD |
| | MN (%) | 90 | 0.0 - 100.0 | 0.7984 | 1.013 (0.880, 1.145) | -2.053 (-6.793, 2.688) | -1.5 | 1 SD |
| | PMN (10^{3}/µL) | 61 | 0.003 - 8.393 | 0.9862 | 0.952 (0.884, 1.021) | -0.044 (-0.122, 0.034) | -0.147 | 1 SD |
| | PMN% (%) | 90 | 0.0 - 100.0 | 0.7984 | 1.013 (0.880, 1.145) | 0.792 (-9.206, 10.791) | 1.5 | 1 SD |
| | TC-BF (10^{3}/µL) | 78 | 0.003 - 9.192 | 0.9968 | 0.997 (0.967, 1.027) | 0.001 (-0.024, 0.027) | -0.006 | -0.24 |
| Peritoneal | WBC-BF (10^{3}/µL) | 107 | 0.004 - 9.766 | 0.9989 | 0.996 (0.982, 1.010) | 0.012 (-0.003, 0.027) | 0.006 | 0.31 |
| | RBC-BF (10^{6}/µL) | 70 | 0.002 - 4.801 | 0.9996 | 0.999 (0.980, 1.017) | 0.004 (-0.003, 0.010) | 0.003 | 0.31 |
| | MN (10^{3}/µL) | 108 | 0.003 - 5.689 | 0.9571 | 1.120 (0.930, 1.310) | -0.019 (-0.089, 0.052) | 0.048 | 1 SD |
| | MN (%) | 109 | 0.6 - 100.0 | 0.9543 | 0.981 (0.940, 1.021) | 1.411 (-0.736, 3.559) | 0.3 | 1 SD |
| | PMN (10^{3}/µL) | 97 | 0.003 - 8.469 | 0.9936 | 0.955 (0.902, 1.008) | 0.017 (-0.015, 0.050) | -0.046 | 1 SD |
| | PMN% (%) | 109 | 0.0 - 99.4 | 0.9543 | 0.981 (0.940, 1.021) | 0.512 (-2.413, 3.437) | -0.3 | 1 SD |
| | TC-BF (10^{3}/µL) | 107 | 0.004 - 9.774 | 0.9988 | 0.997 (0.982, 1.011) | 0.011 (-0.005, 0.026) | 0.005 | 0.26 |

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Sysmex America, Inc.
XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

| Fluid Type | Measurand | N | Result Range | r | Slope (95% CI) | Intercept (95% CI) | Mean Diff. | % Mean Diff. Or SD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Pleural | WBC-BF (10³/μL) | 95 | 0.005 - 9.996 | 0.9982 | 1.017 (0.996, 1.038) | -0.006 (-0.033, 0.021) | 0.032 | 1.42 |
| | RBC-BF (10⁶/μL) | 72 | 0.002 - 4.691 | 0.9998 | 0.994 (0.986, 1.003) | 0.001 (-0.002, 0.004) | -0.003 | -0.41 |
| | MN (10³/μL) | 97 | 0.004 - 5.240 | 0.9786 | 1.225 (1.099, 1.350) | -0.127 (-0.212, -0.041) | 0.112 | 1 SD |
| | MN (%) | 99 | 9.2 - 100.0 | 0.9154 | 1.003 (0.962, 1.044) | 0.317 (-3.802, 4.437) | 0.5 | 1 SD |
| | PMN (10³/μL) | 92 | 0.006 - 8.862 | 0.9882 | 0.937 (0.864, 1.011) | 0.007 (-0.047, 0.060) | -0.083 | 1 SD |
| | PMN% (%) | 99 | 0.0 - 90.8 | 0.9154 | 1.003 (0.962, 1.044) | -0.637 (-2.494, 1.221) | -0.5 | 1 SD |
| | TC-BF (10³/μL) | 94 | 0.006 - 9.437 | 0.9978 | 1.013 (0.989, 1.036) | -0.005 (-0.035, 0.024) | 0.024 | 1.04 |
| Synovial | WBC-BF (10³/μL) | 55 | 0.004 - 9.780 | 0.9980 | 1.003 (0.978, 1.027) | 0.032 (-0.008, 0.072) | 0.041 | 1.21 |
| | RBC-BF (10⁶/μL) | 56 | 0.002 - 4.801 | 0.9998 | 0.987 (0.975, 0.999) | 0.003 (0.000, 0.006) | -0.007 | -0.90 |
| | MN (10³/μL) | 61 | 0.004 - 4.803 | 0.9342 | 1.248 (0.943, 1.554) | -0.156 (-0.345, 0.033) | 0.094 | 1 SD |
| | MN (%) | 65 | 0.0 - 93.1 | 0.9460 | 0.995 (0.900, 1.090) | 0.306 (-1.595, 2.207) | 0.1 | 1 SD |
| | PMN (10³/μL) | 56 | 0.003 - 8.694 | 0.9836 | 0.991 (0.960, 1.023) | -0.033 (-0.144, 0.077) | -0.057 | 1 SD |
| | PMN% (%) | 65 | 6.9 - 100.0 | 0.9460 | 0.995 (0.900, 1.090) | 0.202 (-7.956, 8.361) | -0.1 | 1 SD |
| | TC-BF (10³/μL) | 55 | 0.004 - 9.783 | 0.9979 | 1.003 (0.978, 1.028) | 0.032 (-0.010, 0.074) | 0.042 | 1.22 |

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XR-Series (XR-10) Automated Hematology Analyzer
Premarket Submission

# Matrix Studies:

## Whole Blood Anticoagulant Comparison (K₂EDTA vs. K₃EDTA)

Comparability between K₂EDTA vs. K₃EDTA anticoagulated whole blood samples on the Sysmex XR-Series (XR-10) analyzer were conducted at 1 internal site using 46 paired K₂ and K₃EDTA venous whole blood samples. Testing was run in singlet between K₂ and K₃ EDTA anticoagulant tubes from a single donor and completed within a target of 2 hours. The study was conducted in accordance with CLSI EP09-A3 approved guidelines. The results of the regression analysis and bias analyses between K₂EDTA and K₃EDTA venous whole blood samples met predefined correlation and coefficient and/or bias limits for all applicable parameters and demonstrate equivalency between the two anticoagulants

## Venous Whole Blood vs. Capillary Whole Blood (K₂EDTA)

Comparability between venous whole blood and capillary whole blood samples on the Sysmex XR-Series (XR-10) analyzer was conducted using residual and prospectively collected K₂EDTA (4mL tubes) venous whole blood samples with concentrations representative of patient samples, across medical decision levels, and to the extent possible of the full analytical measurement range of direct measured parameters (WBC, RBC, HGB, HCT and PLT). The comparison study was conducted at one internal site using seventy paired venous whole blood samples. Within 2 hours of analysis of samples in the normal tube position, samples were mixed and transferred to micro-collection tubes (without anticoagulant). Then the samples were placed in the micro collection tube holder position and run in singlet in the manual mode using the same discrete test selections used for normal tube samples on XR-10 analyzer. The study was conducted in accordance with CLSI EP09-A3 approved guidelines. The K₂EDTA sample results from the 4mL tubes were compared to the corresponding results of the micro collection tube. The results of the regression analysis and bias analyses between K₂EDTA 4mL tube samples and micro collection tube samples met predefined correlation and coefficient and/or bias limits for all applicable parameters and demonstrate equivalency between the two collection tubes.

## Whole Blood K₂EDTA Normal Tubes vs. Micro-collection Tube

The study was conducted using residual and prospectively collected K₂EDTA (4mL tubes) venous whole blood samples with concentrations representative of patient samples, across medical decision levels, and to the extent possible of the full analytical measurement range of direct measured parameters (WBC, RBC, HGB, HCT and PLT) of the Sysmex XR-10 analyzer. The comparison study was conducted at one internal site using seventy paired venous whole blood samples. K₂EDTA venous whole blood samples were thoroughly mixed, then placed in the normal tube holder position and run in singlet in the manual mode. Within 2 hours of analysis of samples in the normal tube position, samples were mixed and transferred to micro-collection tubes (without anticoagulant). Then the samples were placed in the micro collection tube holder position and run in singlet in the manual mode. The study was conducted in accordance with CLSI EP09-A3 approved guidelines. The results of the regression analysis and bias analyses between K₂EDTA 4mL tube samples and micro collection tube samples met predefined correlation and coefficient and/or bias limits for all applicable parameters and demonstrate equiv…