(89 days)
No.
The document does not mention the use of AI, DNN, or ML models in the device's description, operation, or performance studies. The device is described as an automated analyzer that performs quantitative parameter enumeration.
No.
This device is an automated hematology analyzer used for in vitro diagnostic purposes to screen patient populations in clinical laboratories by classifying and enumerating various parameters in whole blood and body fluids. It is not intended for treatment or therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use in screening patient populations found in clinical laboratories."
No
The device is a quantitative multi-parameter automated hematology analyzer that processes physical whole blood and bodily fluid samples using a "Main Unit" (XR-10) for aspirating, diluting, mixing, and analyzing, as well as "Auto Sampler Units" and a "Pneumatic Unit." This clearly indicates it is a hardware-based medical device, not software-only.
Yes
The "Intended Use / Indications for Use" section explicitly states "intended for in vitro diagnostic use".
N/A
Intended Use / Indications for 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.
Product codes
GKZ
Device Description
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 consist 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Patient populations found in clinical laboratories. Pediatric (=21 years).
Intended User / Care Setting
Clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical Sensitivity and Specificity
Testing was conducted using patient samples representing a variety of abnormal conditions in comparison to manual differential counts and peripheral blood smear review by experienced examiners using light microscopy (reference method). The study was performed at three external clinical sites from the method comparison study. Three blood film slides were prepared for each sample for manual measurement.
Summary of Performance Studies
Analytical Performance
- Precision (Repeatability) – Whole Blood Mode: Evaluated within-run imprecision using residual K2EDTA whole blood samples in replicates of ten at three US clinical sites. Samples targeted medical decision levels, normal and high measurement ranges for WBC, HGB, PLT, RBC, and HCT. For other parameters, three samples were used. Conducted in accordance with CLSI EP05-A3. %CV estimates were evaluated against acceptance criteria. The XR-10 met manufacturer's specifications.
- Precision (Reproducibility) – Whole Blood Mode: Evaluated within-run, between-run, between-day, between-site, and total imprecision using 3 levels of XN CHECK whole blood control material. Each level was run in triplicate, twice a day for 5 days (90 results per control level). Conducted by a minimum of two operators at three US clinical sites in accordance with CLSI EP05-A3. Results analyzed by ANOVA. The XR-10 results met acceptance criteria.
- Precision (Repeatability) – Body Fluid Mode: Evaluated within-run imprecision using residual peritoneal, pleural, synovial (in K2EDTA), and CSF (without anticoagulant) fluid samples in replicates of ten at three US clinical sites. Samples targeted low and high ends of measurement range for WBC-BF, RBC-BF, TC-BF. Conducted in accordance with CLSI EP05-A3. The %CV of all body fluid parameters met manufacturer's specifications.
- Precision (Reproducibility) – Body Fluid Mode: Evaluated within-run, between-run, between-day, between-site, and total imprecision using 2 levels of XN CHECK BF body fluid control material. Run in triplicate, twice a day for 5 days (60 results per parameter). Conducted by a minimum of two operators at three US clinical sites in accordance with CLSI EP05-A3. Results analyzed by ANOVA. The XR-10 results met manufacturer's specifications.
Linearity
- Whole Blood: Evaluated linearity using WRP CHECK EX whole blood linearity material and system diluent (CELLPACK DCL). A minimum of seven sample dilutions created to span the full measurement range of WBC, RBC, HGB, HCT, PLT-I, and PLT-F. All samples tested in replicates of three on three XR-10 analyzers at one internal site. Conducted in accordance with CLSI EP06-ED2:2020. The method was demonstrated to be linear within the measured maximum allowable deviation. All results met predefined acceptance criteria.
- Body Fluid: Evaluated linearity using a minimum of seven sample dilutions spanning the full measurement range of WBC-BF, RBC-BF, and TC-BF. Samples tested in replicates of three on three XR-10 analyzers at one internal site. Conducted in accordance with CLSI EP06-ED2:2020. The method was demonstrated to be linear within the measured maximum allowable deviation. All results met predefined acceptance criteria.
Analytical Specificity/Interferences
Interfering substances studies for Bilirubin F, Bilirubin C, Chyle, Hemolytic Hemoglobin, Lipids, and high WBC, RBC, and platelet counts and microcytic RBCs to determine concentration that impact all claimed parameters. Whole blood K2EDTA samples were collected from donors for this study and varying concentrations of interferent was added. Samples were measured in four consecutive batches. Significant interference was observed for MCHC with Chyle (above 2,880 FTU), MCH and MCHC with Hemolytic Hemoglobin (above 800mg/dL and 400mg/dL respectively), and HGB, MCH, and MCHC with Lipids (Intralipos above 0.20 g/dL, and 0.10 g/dL for MCHC). All other parameters and interferents showed no significant interference up to the tested concentrations.
Sample Stability
- Whole Blood Stability: Evaluation at one internal site using 8 unique leftover and 12 prospectively collected de-identified K2EDTA venous whole blood samples. Samples stored at room temperature (18-26°C) and refrigerated (2-8°C). Tested in duplicate at baseline, 6, 24, 25, 48, 49, 72, and 73 hours. Data supports 24 hours stability at room temperature and 48 hours at refrigerated temperature.
- Body Fluid Short-term Stability: Evaluation at one external site using 12 unique de-identified leftover body fluid samples (3-CSF, 3-peritoneal, 3-pleural, 3-synovial). Peritoneal, pleural, and synovial samples in K2EDTA, CSF without anticoagulant. Tested in singlet at baseline, 1, 2, and 4 hours at RT (18-26°C). Body fluid samples should be analyzed within 1 hour of collection.
Detection Limit
Limits of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) were determined for direct measured WBC, RBC, HGB, HCT, PLT parameters for Whole Blood Mode and WBC-BF, RBC-BF, TC-BF for Body Fluid Mode.
Carry-Over
- Whole Blood: Three sets of carryover sequences run for applicable parameters at three US clinical sites using de-identified leftover venous whole blood samples in K2EDTA. High target concentration samples followed by low target concentration samples (3 replicates each). Conducted in accordance with CLSI H26-A2. All applicable parameters met manufacturer's specifications.
- Body Fluid: Carryover conducted using de-identified peritoneal, pleural, synovial fluids (K2EDTA), and CSF (no anticoagulant) with high and low target WBC-BF, RBC-BF, and TC-BF. Three sets of carryover sequences run at three US clinical sites. Conducted in accordance with CLSI H26-A2. All applicable parameters met manufacturer's specifications.
Comparison Studies
- Whole Blood - Method Comparison with Predicate Device: Compared to Sysmex XN-20 (K112605). 865 unique residual whole blood samples in K2EDTA from pediatrics (=21 years), including variety of disease states, tested across 3 US clinical sites. 20 samples excluded. Sample demographics: 310 pediatric, 551 adults, 4 age not reported; 53.7% male, 45.8% female, 0.5% sex not reported. 362 normal, 500 abnormal samples. Linear regression and bias analyses results met acceptance criteria for correlation coefficient (r) and %Bias, with one exception for HGB bias at one site (-2.10%, -0.3 g/dL) slightly above predefined limits (±2% or 0.2g/dL) but accepted due to high correlation (0.9932).
- Body Fluid - Method Comparison with Predicate Device: Compared to Sysmex XN-20 (K112605). 397 residual body fluid samples at three US sites. 2 samples excluded. All body fluids (peritoneal, pleural, synovial) collected in K2EDTA except CSF. Samples run in singlet on XN-20 and within two hours on XR-10. Samples covered clinical medical decision levels and full measuring ranges. Linear regression and bias analyses results shown for CSF, peritoneal, pleural, and synovial fluids.
Matrix Studies
- Whole Blood Anticoagulant Comparison (K2EDTA vs. K3EDTA): Conducted at 1 internal site using 46 paired K2 and K3EDTA venous whole blood samples. Tested in singlet within 2 hours. Conducted in accordance with CLSI EP09-A3. Results of regression and bias analyses met predefined correlation coefficient and/or bias limits, demonstrating equivalency.
- Venous Whole Blood vs. Capillary Whole Blood (K2EDTA): Conducted at one internal site using 70 paired venous whole blood samples (4mL tubes). Samples (without anticoagulant) transferred to micro-collection tubes and run in manual mode. Conducted in accordance with CLSI EP09-A3. Results of regression and bias analyses met predefined correlation coefficient and/or bias limits, demonstrating equivalency.
- Whole Blood K2EDTA Normal Tubes vs. Micro-collection Tube: Conducted at one internal site using 70 paired venous whole blood samples (4mL tubes). Samples (without anticoagulant) transferred to micro-collection tubes and run in manual mode. Conducted in accordance with CLSI EP09-A3. Results of regression and bias analyses met predefined correlation coefficient and/or bias limits, demonstrating equivalency.
Bridging Studies
- Whole Blood Mode to Pre-dilute Mode Comparison: Conducted at 1 internal site using 45 de-identified residual whole blood samples and system diluent (1:7 dilution). Whole blood samples run in singlet in whole blood mode. Diluted samples run in singlet in pre-dilution mode (results automatically multiplied by 7). Conducted in accordance with CLSI EP09-A3. Comparison data met predefined correlation coefficient and/or bias limits, demonstrating equivalency.
- Predilute Mode Normal Tube to Micro-collection Tube Comparison: Conducted at one internal site using 40 de-identified residual whole blood samples and system diluent (1:7 dilution). Diluted samples run in normal tube holder position, then transferred to micro-collection tubes and run in micro collection tube holder position. Conducted in accordance with CLSI EP09-A3. Comparison data met predefined correlation coefficient and/or bias limits, demonstrating equivalency.
- Low WBC Mode Normal Tube to Micro collection Tube Comparison: Conducted at one internal site using 43 residual de-identified venous whole blood samples with low WBC concentrations (
§ 864.5220 Automated differential cell counter.
(a)
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.(b)
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.”
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
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.
Page 2
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-
Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Page 4
Indications for Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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.
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"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."
Page 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: 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: doswelly@sysmex.com
Phone: (678) 274-8024
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
Page 6
- 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 consist 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.
Page 7
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 |
Page 8
| 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 K₂ or K₃EDTA | 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 |
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| 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.
Page 10
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.
Page 11
| 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 |
Page 12
| 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 |
Page 13
| 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 |
Page 14
| 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 |
Page 15
| 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 |
Page 16
| 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 17
| 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 |
Page 18
| 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 |
Page 19
| 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.
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| Parameter | Control Level | N | Mean | Within Run | Between Run | Between Day | Between Site | Total Precision | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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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| Parameter | Control Level | N | Mean | Within Run | Between Run | Between Day | Between Site | Total Precision | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
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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.
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| Parameter | Control Level | N | Mean | Within Run | Between Run | Between Day | Between Site | Total Precision | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | %SD | %CV | ||||
| WBC-BF (10³/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 (10⁶/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 (10³/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 (10³/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 (10³/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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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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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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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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| 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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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) to ranges established for a predicate device Sysmex XE-5000 (K071967). One hundred and thirty-two samples (58 males and 74 females) were tested and compared to pre-established reference intervals to determine if the ranges were applicable for use with Sysmex XR-10 Automated Hematology analyzers. The results of the proposed reference intervals overlapped the 95% confidence intervals (lower and upper limit) of the adult male and female and were determined to be acceptable.
Whole Blood - Verification of Pediatric Reference Intervals
Using Pediatric Reference Interval literature source (Wong, E., Brugnara, C., Straseski, J., Kellogg, M., & Adeli, K. 2021. Pediatric Reference Intervals. 8th ed., Hematology Tests (pp. 209-267), Academic Press.), reference interval verification study was performed for the pediatric population. A total of 196 pediatric samples including each subpopulation: 40 neonates (birth–28 days); 55 infants (>28 days–2 years); 60 children (>2 years–12 years); and 41 adolescents (>12 years–21 years) were used in the study. The results of the proposed reference intervals overlapped the 95% confidence intervals (lower and upper limit) of the pediatric datasets from XR-10 for all parameters.
Body Fluid – Verification of Reference Intervals
A verification study was conducted using a minimum of 20 normal CSF and 20 normal Synovial fluids to verify normal reference ranges cited from published literature (Kjeldsberg's Body Fluids, Third Edition (1993). Reference intervals for other body fluid types have not been established. According to Kjeldsberg (1193), reference intervals for RBC counts are not applicable in body fluid, and therefore, no reference interval for RBC has been established.
Conclusions:
The XR-Series (XR-10) Automated Hematology analyzer and its predicate device, XN-20 Automated Hematology analyzer (K112605), have similar indications for use, fundamental technology, and principles of operation.
Performance, verification, and validation testing were conducted to characterize the performance of the XR-Series (XR-10) analyzer using predetermined acceptance criteria. Results of this testing have demonstrated that the XR-Series (XR-10) analyzer is substantially equivalent to the XN-20 analyzer.
The differences in the XR-Series (XR-10) analyzer and the predicate device (XN-20 analyzer) do not raise any questions regarding safety and effectiveness.