The Sysmex XW-100™ is a quantitative automated hematology analyzer in vitro diagnostic point of care use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#, RDW-SD. RDW-CV. and MPV. It is not for use in diagnosing or monitoring oncology patients, children under the age of 2, or for chronically or critically ill patients.

XW QC CHECK is a stabilized whole blood matrix designed for statistical process control of the Sysmex XW-100 automated hematology analyzer. It is not intended for calibration of the analyzer. Assayed parameters include WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#, RDW-SD, RDW-CV, and MPV.

Device Description

The XW-100 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 17 hematology parameters, including the basic complete blood count (CBC), 3 part white blood cell (WBC) differential, and commonly used CBC indices. 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 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 or 59°F-77°F).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sysmex XW-100™ and XW QC CHECK devices, based on the information available:

The document is a 510(k) premarket notification letter from the FDA, along with summaries for the Sysmex XW-100 Automated Hematology Analyzer and XW QC CHECK control material. The main purpose of these summaries is to demonstrate substantial equivalence to predicate devices, not typically to define explicit acceptance criteria in the same way a detailed validation study report would. Therefore, some requested information might not be explicitly stated.

Acceptance Criteria and Study for Sysmex XW-100™ and XW QC CHECK

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a structured table. Instead, it makes a general statement about the performance.

Acceptance Criteria (Not explicitly stated as quantitative thresholds in this document)	Reported Device Performance
Sysmex XW-100™ (Automated Hematology Analyzer)
Equivalent performance to predicate device (Sysmex pocH-100i™) in a point-of-care (POC) setting.	"Results indicated equivalent performance."
XW QC CHECK (Control Material)
Met clinical performance acceptability criteria for open-vial stability, closed-vial stability, and precision.	"All testing showed that XW QC CHECK met clinical performance acceptability criteria and demonstrated stability for the shelf-life claimed."

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

Sysmex XW-100™ Analyzer: The document states that "Studies were performed to evaluate the equivalency of the Sysmex XW-100 in the point-of-care (POC) setting with the Sysmex pocH-100i automated hematology analyzer."
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
XW QC CHECK Control Material: The document states "Open-vial stability, closed-vial stability, and precision performance studies were conducted to establish performance of XW QC CHECK."
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not available in the provided text. For an automated hematology analyzer and control material, "ground truth" would typically be established by reference methods or predicate devices, rather than expert interpretation of raw data.

4. Adjudication Method for the Test Set

This information is not available in the provided text. Adjudication methods (like 2+1 or 3+1) are typically used for subjective assessments where multiple human readers are involved in creating a consensus ground truth. For an automated hematology analyzer, the "ground truth" would usually be established via a reference method or comparison to a predicate device, which wouldn't involve human adjudication in this manner.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

This information is not available and is not applicable to this type of device. An MRMC study involves multiple human readers evaluating cases, often with and without AI assistance, to measure the improvement in human performance. The Sysmex XW-100™ is an automated analyzer, not an AI-assisted interpretation tool for human readers.

6. If Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, implicitly. The Sysmex XW-100™ is an automated hematology analyzer. Its performance is its standalone performance without human input beyond sample loading and results interpretation. The studies described are inherently standalone evaluations of the device's ability to classify and enumerate blood parameters. The comparison is to a predicate device, not to human readers.

7. The Type of Ground Truth Used

For the Sysmex XW-100™ Analyzer: The ground truth for evaluating its performance was established by comparison to the Sysmex pocH-100i™ Automated Hematology Analyzer (predicate device). The goal was to demonstrate "equivalent performance" to this existing device. This implies that the predicate device's results served as the reference or "ground truth" against which the new device's measurements were compared.
For the XW QC CHECK Control Material: The ground truth for its performance (stability and precision) would be against defined acceptable ranges or established values, often determined by reference methods or internal validation standards for quality control materials for automated hematology analyzers. The document states it "met clinical performance acceptability criteria," implying established reference points.

8. The Sample Size for the Training Set

This information is not available in the provided text. Automated hematology analyzers like the Sysmex XW-100™ are typically based on well-established physical principles (e.g., electrical impedance, photometric measurement) rather than machine learning models that require explicit "training sets" in the contemporary sense of AI development. While there are internal calibrations and optimizations, they are not typically referred to as a "training set" in this context.

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

This information is not available and is not applicable in the AI/machine learning sense for this device. As noted above, the device operates on established physical principles. Any internal calibration or optimization would rely on reference measurements and established standards, rather than a "ground truth" for a training set as would be established for a machine learning algorithm.

Summary

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

October 12, 2015

Sysmex America, Inc. Peter Shearstone VP, RA/QA/Clinical and Medical Affairs 577 Aptakisic Road Lincolnshire, IL 60069

Re: K143577

Trade/Device Name: Sysmex XW-100™, XW QC CHECK Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ, JPK Dated: September 24, 2015 Received: September 28, 2015

Dear Mr. Shearstone:

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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Leonthena R. Carrington -S

Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143577

Device Name Sysmex XW-100 XW QC CHECK

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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Image /page/3/Picture/0 description: The image shows the Sysmex logo. The logo consists of a stylized graphic element in the upper left and the word "sysmex" in blue to the right of the graphic. The graphic element is composed of two overlapping shapes, one in blue and the other in green, creating a sense of movement or flow.

The 510(k) summary for the Sysmex XW-100 Automated Hematology Analyzer instrument is presented in Table 5.1, and the similarities and differences between the Sysmex XW-100 and predicate pocH-100i devices are provided in Table 5.2.

Table 5.1	Sysmex XW-100 Automated Hematology Analyzer 510(k) Summary
1. Submitted by	Sysmex America, Inc.577 Aptakisic RdLincolnshire, IL 60069Phone: 224.543.9514Fax: 224.543.4699Contact person: Peter ShearstoneDate prepared: December 16, 2014
2. Name of device	Trade or proprietary name: Sysmex XW-100™Common name: XW-100 Automated Hematology AnalyzerClassification name: Automated Differential Cell CounterRegulation number: 21 CFR 864.5220Classification: Class 2Product Code: GKZ
3. Predicate device	Sysmex pocH-100i™ Automated Hematology Analyzer
4. Device description	The XW-100 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 bloodspecimen and produces results for 17 hematology parameters,including the basic complete blood count (CBC), 3 part whiteblood cell (WBC) differential, and commonly used CBC indices.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 each cell size category. The analyzer then determines blood cell
Table 5.1	Sysmex XW-100 Automated Hematology Analyzer 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 AutomatedHematology Analyzer comprise XW QC CHECK, which containsstabilized red blood cell component(s), stabilized WBCcomponent(s), and stabilized platelet component(s) in apreserving medium. XW QC CHECK components are packagedin glass vials with screw caps containing 2 mL. The vials arepackaged in a welled vacuum-formed clamshell container.XW QC CHECK is stored at room temperature (15°C-25°C or59°F-77°F).
5. Substantial equivalence-similarities and differences	Table 5.2 compares the Sysmex XW-100 with theSysmex pocH-100i automated hematology
6. Clinical performance data	Studies were performed to evaluate the equivalency of theSysmex XW-100 in the point-of-care (POC) setting with theSysmex pocH-100i automated hematology analyzer. Resultsindicated equivalent performance.Open-vial stability, closed-vial stability, and precisionperformance studies were conducted to establish performance ofXW QC CHECK; all testing showed that XW QC CHECK metclinical performance acceptability criteria and demonstratedstability for the shelf-life claimed.
7. Conclusions	The performance data demonstrated substantial equivalence to thepredicate device.

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Image /page/4/Picture/0 description: The image contains the logo for Sysmex. The logo features a stylized wave-like graphic in shades of blue and green above the company name. The company name "sysmex" is written in lowercase, bold, blue letters.

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Image /page/5/Picture/2 description: The image shows the Sysmex logo. The logo consists of a stylized graphic element in the upper left and the word "sysmex" in blue, sans-serif font to the right of the graphic. The graphic element is composed of two shapes, one in blue and one in green, that appear to be intertwined or overlapping.

Sysmex XW QC CHECK

The 510(k) summary for the control material, XW QC CHECK, is presented in Table 5.3, and the similarities and differences between the XW-QC CHECK and predicate Para Check control material are provided in Table 5.4.

Table 5.3	XW QC CHECK
1. Submitted by	Sysmex America, Inc.577 Aptakisic RdLincolnshire, IL 60069Telephone: 224.543.9514Fax: 224.543.4699Contact person: Peter ShearstoneDate prepared: December 16, 2014
2. Name of device	Trade or proprietary name: XW QC CHECKCommon Name: XW Quality ControlsClassification Name: Hematology quality control mixture(864.8625)Product Code: JPK
3. Predicate device	Para® Check (K852992)
4. Device description	XW QC CHECK is an in vitro diagnostic product that containsthe following: stabilized red blood cell component(s), stabilizedwhite blood cell component(s), and stabilized plateletcomponent(s) in a preserving medium. The product is packagedin glass vials with screw caps containing 2 mL. The vials will bepackaged in a welled vacuum-formed clamshell container. Theproduct is stored at (15°C-25°C or 59°F-77°F) subsequent toshipment.
5. Substantial equivalence-similarities and differences	Table 5.4 compares XW QC CHECK with the Para® Check.
6. Clinical performance data	Open-vial stability, closed-vial stability, and precisionperformance studies were conducted to establish performance ofXW QC CHECK. All testing showed that XW QC CHECK metclinical performance acceptability criteria and demonstratedstability for the shelf-life claimed.
7. Conclusions	The performance data demonstrated substantial equivalence to thepredicate device

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.”