The Sysmex® XE-2100 Series Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Body Fluid Application adds a quantitative, automated procedure for analyzing cerebrospinal fluid, scrous fluid and synovial fluid to the XE-2100 Series, providing enumeration of the WBCs and the RBCs.

Device Description

The XE-2100 Series is an automated hematology analyzer previously cleared by the FDA. The combination of side scatter, forward scatter, and fluorescent intensity of nucleated cells gives an image of each cell detected in the specimen.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Sysmex® XE-2100 Series Automated Hematology Analyzer, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Predicate: Manual Cell Counting)	Reported Device Performance
Quantitative determination of blood cells in cerebrospinal fluid, serous fluid, and synovial fluid.	Same as predicate method (quantitative determination of blood cells).
Method of cell counting using a microscope established as the predicate method.	Comparison to manual count showed good correlation.
The reproducibility and accuracy of the manual method will vary due to differences in technologist skill and experience; it is labor-intensive and time-consuming.	The reproducibility and accuracy of an automated method is more consistent, not subject to manual variation. Analyzes a large number of cells and uses multiple parameters (FSC, SSC, fluorescent labels) for identification, rather than morphological appearance alone.

Study Information

2. Sample size used for the test set and the data provenance:

Test set size: Not explicitly stated. The text mentions "Studies were performed to evaluate the equivalency of the automated method to the predicate method," implying a test set was used, but the number of samples is not provided.
Data provenance: Not explicitly stated. Likely retrospective, as it compares the new device to an established manual method. The country of origin is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not explicitly stated. The predicate method involves "manual cell counting in a counting chamber by a skilled, competent technologist." This implies a human expert performing the ground truth measurement, but the number and specific qualifications (beyond "skilled, competent technologist") are not detailed.

4. Adjudication method for the test set:

Adjudication method: Not explicitly stated. Given the comparison to a manual method performed by a "skilled, competent technologist," it's likely the manual count served as the direct reference, without a formal adjudication process between multiple experts for the test set ground truth. The study's "good correlation" implies a direct comparison.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC study: No. This device is an automated hematology analyzer, not an AI-assisted diagnostic tool for human readers in the traditional sense of image interpretation. The comparison is between an automated machine and a manual human counting method, not about improving human reader performance with AI. Therefore, an effect size of human improvement is not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone performance: Yes. The study directly evaluates the "automated method" (the device) against the "predicate method" (manual counting). The performance comparison ("Comparison to manual count showed good correlation") indicates a standalone evaluation of the device's accuracy without a human-in-the-loop.

7. The type of ground truth used:

Ground truth type: Expert consensus (implicitly, through a "skilled, competent technologist" performing manual counts) for cell enumeration. The predicate method is "manual cell counting in a counting chamber by a skilled, competent technologist," which serves as the reference standard.

8. The sample size for the training set:

Training set size: Not applicable or provided. Automated hematology analyzers typically use established algorithms and calibration methods rather than machine learning training sets in the modern sense. The device was "previously cleared by the FDA," suggesting its core technology was already developed. The "Body Fluid Application" is an added quantitative, automated procedure for specific fluid types, implying an extension of existing capabilities, not necessarily a new machine learning model requiring a distinct training set.

9. How the ground truth for the training set was established:

Ground truth for training set: Not applicable or provided. As inferred above, this device's development likely involved engineering and calibration against known standards rather than a machine learning training paradigm with annotated ground truth.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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: ______________________________________________________________________________

1. Submitted by:	Sysmex America, Inc.One Nelson C. White ParkwayMundelein, IL 60060Phone: (847) 996-4675; FAX: (847) 996-4655Contact person: Nina GamperlingDate prepared: January 13, 2004
2. Name of Device:	Trade or proprietary name: Sysmex® Automated HematologyAnalyzer, XE-2100 SeriesCommon name: Automated Hematology Analyzer.Classification name: Sysmex® XE-Series, AutomatedHematology, an Automated Differential Cell Counter (21 CFR864.5220) is a Class II medical device.
3. Predicate Method:	The Sysmex® XE-2100 Series Body Fluid Application claimssubstantial equivalence to the pre-amendment predicate methodfor the enumeration of WBCs and RBCs of manual cell countingin a counting chamber by a skilled, competent technologist.
4. Device Description:	The XE-2100 Series is an automated hematology analyzerpreviously cleared by the FDA. The combination of side scatter,forward scatter, and fluorescent intensity of nucleated cells givesan image of each cell detected in the specimen.
5. Intended Use:	The Sysmex® XE-2100 Series Hematology Analyzer is aquantitative, automated hematology analyzer and leukocytedifferential counter For In Vitro Diagnostic Use in clinicallaboratories. The Body Fluid Application adds a quantitative,automated procedure for analyzing cerebrospinal fluid, scrousfluid and synovial fluid to the XE-2100 Series, providingenumeration of the WBCs and the RBCs.
6. Substantialequivalence-similaritiesand differences	The following table compares the XE-2100 Series Body FluidApplication with the predicate method.

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

Comparison to Predicate Method		XE-2100 Series Body Fluid Application
	Manual Method	Automated Method
Intended Use	To provide a quantitativedetermination of blood cells incerebrospinal fluid, serous fluidand synovial fluid.	Same as predicate method
Methodology	Cell count is performed manuallyin a counting chamber by a skilledcompetent technologist.	Cell count is performed on an automatedhematology analyzer.
Specimen Type	Cerebrospinal fluid, Serous fluid,Synovial fluid	Same as predicate method
Performance	Method of cell counting using amicroscope established as thepredicate method.	Comparison to manual count showedgood correlation.
Pro/Con	The reproducibility and accuracyof the manual method will varydue to the differences intechnologist skill and experience.It is a labor intensive and time-consuming method.	The reproducibility and accuracy of anautomated method is more consistentsince this method is not subject to thevariation of the manual method. A largenumber of cells can be analyzed andseveral parameters (i.e. forward scatter[FSC], side scatter [SSC], and fluorescentlabels) rather than morphologicalappearance alone can be used to identifythe blood cells.

Comparison to Predicate Method

7. Clinical Performance Data:	Studies were performed to evaluate the equivalency ofthe automated method to the predicate method. Resultsindicated equivalent performance.
8. Conclusions:	The performance data demonstrated substantialequivalence.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 8 2004

Ms. Nina M. Gamperling Manager, Regulatory Affairs Sysmex America, Inc. One Nelson C. White Parkway Mundelein, IL 60060

Re: K040073

Trade/Device Name: Sysmex® XE-2100 Series, Automated Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: January 13, 2004 Received: January 16, 2004

Dear Ms. Gamperling:

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 for too battled in 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific information about the application of labeling requirements to your device, or you don't on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may ocann of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Joseph L. Aralett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

K040073 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Sysmex® XE-2100 Series, Automated Hematology Analyzer

Indications For Use:

The Sysmex® XE-2100 Series Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Body Fluid Application adds a quantitative, automated procedure for analyzing cerebrospinal fluid, serous fluid and synovial fluid to the XE-2100 Series, providing enumeration of the WBCs and the RBCs.

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Concurrence of CHRD, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

signature

Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Body Fluid Application on Sysmcx XE-2100 Series 510(k) FDA Submission

(k) K640073

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.”