The XW-100 Automated Hematology Analyzer (XW-100) is a quantitative automated hematology analyzer intended for in vitro diagnostic use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, and NEUT#. It is not for use in diagnosing or monitoring patients with primary or secondary chronic hematologic diseases/ disorders, oncology patients, critically ill patients, or children under the age of 2.

Device Description

The XW-100 Automated Hematology Analyzer is an electrical resistance type blood cell counter. This technology may be variously referred to as direct current (DC) or impedance. The analyzer uses a human whole blood specimen and produces results for 12 hematology parameters, including the basic complete blood count (CBC), 3 part white blood cell (WBC) differential, and MCV. The analyzer uses DC with hydrodynamic focusing for all parameters except hemoglobin, which is measured photometrically. The patient sample is aspirated, measured, diluted with diluent (and Lyse for WBC measurement), then fed into a transducer chamber by means of a hydrodynamic focusing nozzle. The transducer chamber has a minute hole, or aperture. Electrodes are mounted on both sides of the aperture chamber, through which flows the DC. Blood cells suspended in the diluted sample are injected through the aperture by the hydrodynamic focusing nozzle. The hydrodynamic focusing nozzle is positioned in front of the aperture and in line with the aperture's center. This method improves cell counting accuracy because all blood cells are separated from each other and can only pass through the aperture in 1 direction, 1 at a time. When a cell passes through the aperture, it causes a change in the DC resistance that is directly proportional to its size. These resistance changes are captured as electric pulses. The various blood cell counts are calculated by counting the pulses that occur in each cell size category. The analyzer then determines blood cell volume and identifies rare and pathological cells by creating and analyzing histograms of the various cell populations using their respective pulse heights. Hemoglobin is measured photometrically using a noncyanide methodology, which reduces the presence of hazardous materials in the analyzer waste stream. The quality controls that are used with the XW-100 CLIA Waived Automated Hematology Analyzer comprise XW QC CHECK, which contains stabilized red blood cell component(s), stabilized WBC component(s), and stabilized platelet component(s) in a preserving medium. XW QC CHECK components are packaged in glass vials with screw caps containing 2 mL. The vials are packaged in a welled vacuum- formed clamshell container. XW QC CHECK is stored at room temperature (15°C-25°C).

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to clinical performance data in K143577 and clinical field data and flex studies in CW170004. Without access to these referenced documents, a specific table of acceptance criteria and reported device performance cannot be generated. However, the summary states that "The performance data demonstrated substantial equivalence to the predicate device." This implies that the device met the performance requirements that allowed it to be deemed substantially equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

The available document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the clinical performance data (K143577) or the clinical field data and flex studies (CW170004).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the given document.

4. Adjudication Method for the Test Set:

This information is not provided in the given document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or described in the provided text. The device described, the XW-100 Automated Hematology Analyzer, is an automated diagnostic device, not one typically involving human readers for interpretation in the same way as, for example, an imaging diagnostic AI.

6. Standalone (Algorithm Only) Performance Study:

The information presented describes the automated hematology analyzer as a standalone device. Its performance data (referenced in K143577 and CW170004) would pertain to its direct measurements and classifications without direct human-in-the-loop intervention during the analysis process, as it is an "Automated Hematology Analyzer."

7. Type of Ground Truth Used:

While not explicitly stated for the referenced studies, for automated hematology analyzers, the common ground truth for evaluating performance would generally involve:

Reference Methods: Comparison to established, highly accurate reference methods (e.g., manual microscopy and differential counts performed by highly experienced laboratory technologists) for cell enumeration and classification.
Clinical Outcomes/Pathology: For certain parameters, correlation with patient pathology reports or clinical outcomes might also be used as a broader validation.

8. Sample Size for the Training Set:

The document does not provide information regarding a specific training set size. Automated hematology analyzers like the XW-100 are typically developed and calibrated using extensive internal datasets, but the details of these are not included here.

9. How Ground Truth for the Training Set Was Established:

This information is not provided in the given document. For such devices, the ground truth for training data would typically be established through well-defined laboratory protocols, including manual differential counts by expert morphologists and correlation with other established diagnostic techniques.

Summary

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November 6, 2017

Sysmex America, Inc. Michelle Abraham Manager. Regulatory Affairs 577 Aptakisic Road Lincolnshire, Illinois 60069

Re: K172604

Trade/Device Name: XW-100 Automated Hematology Analyzer for CLIA Waived Use Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: August 28, 2017 Received: August 30, 2017

Dear Michelle Abraham:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Leonthena R. Carrington -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K172604

Device Name

XW-100 Automated Hematology Analyzer

Indications for Use (Describe)

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)

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The 510(k) summary for the Sysmex XW-100 CLIA Waived Automated Hematology Analyzer instrument is presented in Table 1.0, and the similarities and differences between the Sysmex XW-100 Automated Hematology Analyzer for CLIA Waived use and predicate XW-100 Point of Care devices are provided in Table 2.0.

Table 1.0 Sysmex XW-100 Automated Hematology Analyzer 510(k) Summary
1. Submitted by	Sysmex America, Inc.577 Aptakisic RdLincolnshire, IL 60069Phone: 224.543.9639Fax: 224.543.4699Contact person: Michelle AbrahamDate prepared: August 28, 2017
2. Name of device	Trade or proprietary name: Sysmex XW-100Common name: XW-100 Automated Hematology AnalyzerClassification name: Automated Differential Cell CounterRegulation number: 21 CFR 864.5220Classification: Class 2Product Code: GKZ
3. Predicate device	Sysmex XW-100 Automated Hematology Analyzer for Point ofCare Use
4. Device description	The XW-100 Automated Hematology Analyzer is an electricalresistance type blood cell counter. This technology may bevariously referred to as direct current (DC) or impedance. Theanalyzer uses a human whole blood specimen and producesresults for 12 hematology parameters, including the basiccomplete blood count (CBC), 3 part white blood cell (WBC)differential, and MCV.The analyzer uses DC with hydrodynamic focusing for allparameters except hemoglobin, which is measuredphotometrically. The patient sample is aspirated, measured,diluted with diluent (and Lyse for WBC measurement), then fedinto a transducer chamber by means of a hydrodynamic focusingnozzle. The transducer chamber has a minute hole, or aperture.Electrodes are mounted on both sides of the aperture chamber,through which flows the DC. Blood cells suspended in thediluted sample are injected through the aperture by thehydrodynamic focusing nozzle. The hydrodynamic focusingnozzle is positioned in front of the aperture and in line with theaperture's center. This method improves cell counting accuracybecause all blood cells are separated from each other and can onlypass through the aperture in 1 direction, 1 at a time. When a cellpasses through the aperture, it causes a change in the DCresistance that is directly proportional to its size. These resistancechanges are captured as electric pulses. The various blood cellcounts are calculated by counting the pulses that occur in eachcell size category. The analyzer then determines blood cell
Table 1.0 Sysmex XW-100 Automated Hematology Analyzer Use 510(k) Summary
	volume and identifies rare and pathological cells by creating andanalyzing histograms of the various cell populations using theirrespective pulse heights. Hemoglobin is measuredphotometrically using a noncyanide methodology, which reducesthe presence of hazardous materials in the analyzer waste stream.The quality controls that are used with the XW-100 CLIAWaived Automated Hematology Analyzer comprise XW QCCHECK, which contains stabilized red blood cell component(s),stabilized WBC component(s), and stabilized plateletcomponent(s) in a preserving medium. XW QC CHECKcomponents are packaged in glass vials with screw capscontaining 2 mL. The vials are packaged in a welled vacuum-formed clamshell container.XW QC CHECK is stored at room temperature (15°C-25°C).
5. Substantial equivalence-similarities and differences	Table 2.0 compares the Sysmex XW-100 AutomatedHematology Analyzer for CLIA Waived Use with theSysmex XW-100 Automated Hematology Analyzerfor Point of Care Use.
6. Clinical performance data	Please reference K143577 for clinical performance data andCW170004 for clinical field data and flex studies.
7. Conclusions	The performance data demonstrated substantial equivalence to thepredicate device.

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Table 2.0 Similarities and Differences Table
Item	Device	Predicate(K143577)
Intended Use	The XW-100 Automated HematologyAnalyzer (XW-100) is a quantitativeautomated hematology analyzerintended for in vitro diagnostic use toclassify and enumerate the followingparameters for venous whole bloodanticoagulated with K2/K3 EDTA:WBC, RBC, HGB, HCT, MCV, PLT,LYM%, Other WBC%, NEUT%,LYM#, Other WBC#, and NEUT#. Itis not for use in diagnosing ormonitoring patients with primary orsecondary chronic hematologicdiseases/disorders, oncology patients,critically ill patients, or children underthe age of 2.	The Sysmex XW-100TM is aquantitative automatedhematology analyzer intended forin vitro diagnostic point-of- careuse to classify and enumerate thefollowing parameters for venouswhole blood anticoagulated withK2/K3 EDTA: WBC, RBC,HGB, HCT, MCV, MCH,MCHC, PLT, LYM%, OtherWBC%, NEUT%, LYM#, OtherWBC#, NEUT#, RDW-SD,RDW-CV, andMPV. It is not for use indiagnosing or monitoringoncology patients, children underthe age of 2, or for chronically orcritically ill patients.
Test Principle	Impedance technology (direct currentdetection) with hydrodynamic focusingfor all parameters except hemoglobin,which is measured photometrically.	Same
Measuring Channel	Single hydrodynamic focusedimpedance chamber	Same
Sample Type	Anticoagulated (K2EDTA or K3EDTA)venous whole blood	Same
Sample aspirationvolume	15 μL	Same
Analysis Reagents	XW Pack L (lyse)XW Pack D (diluent)	Same
System Throughput	20 cycles per hour	Same
Test SystemDimensions	Width: 7 inchesHeight: 14 inchesDepth: 18 inches	Same
Mode of Operation	Whole blood mode	Same
Calibration andQuality Control	XW QC CHECK (K143577)SCSTM-1000 calibrator (K943268)	Same

Regulation Number and Section

§ 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.”