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 (PLT-I, PLT-F), 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 with CSF specimens is neither required nor recommended.

Device Description

The Sysmex® XN-Series modules (XN-10, XN-20) are multi-parameter hematology analyzers intended to perform tests on whole blood samples collected in K₂ or K₃EDTA and body fluids (pleural, peritoneal and synovial) collected in K₂ anticoagulant. It can also perform tests on CSF which should not be collected in any anticoagulant. The instrument consists of four principal units: (1) Two Main Units (XN-10, XN-20) which aspirate, dilute, mix, and analyze blood and body fluid samples; (2) Two Auto Sampler Units (SA-10, SA-20) 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. The XN-Series analyzers perform analysis using the following methods: RF/DC Detection Method, Sheath Flow DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. The XN-Series analyzers automatically classify cells from whole blood and body fluids and carry out all processes automatically from aspiration of the sample to outputting the results.

The body fluid analysis mode of the XN-Series analyzers uses the 4DIFF scattergram & the RBC distribution obtained from a specialized analysis sequence to calculate & display the WBC (WBC-BF) counts, mononuclear cell (MN) / polymorphonuclear cell (PMN) counts & 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.

AI/ML Overview

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

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on establishing substantial equivalence to a predicate device (Sysmex XE-5000) rather than explicitly stating acceptance criteria values for each parameter. Instead, it states that "Studies were performed to evaluate the equivalency of the XN-Series Automated Hematology analyzers (Modules XN-10, XN-20) to the XE-5000 Automated Hematology analyzer. Results indicated equivalent performance."

However, it does describe the types of tests performed to demonstrate performance:

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Equivalency	Equivalent performance to the Sysmex XE-5000.
Accuracy	Data collected to show performance to manufacturer's specifications for Body Fluid mode.
Precision	Data collected to show performance to manufacturer's specifications for Body Fluid mode.
Linearity	Data collected to show performance to manufacturer's specifications for Body Fluid mode.
Carryover	Data collected to show performance to manufacturer's specifications for Body Fluid mode.

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

The document does not explicitly state the sample size used for the test set. It mentions "Studies were performed," but no specific numbers of samples are provided.

Regarding data provenance, the document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the given text. The document refers to "manufacturer's specifications" for performance but does not detail how ground truth for the clinical performance data was established or if it involved human expert review for individual cases.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted or described in the provided text. The study focused on demonstrating "equivalency" to a predicate device rather than comparing human reader performance with and without AI assistance from the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was conducted. The document states: "Data consisting of Accuracy, Precision, Linearity and Carryover were collected to show performance to the manufacturer's specification for the Body Fluid mode." This implies a technical validation of the instrument's (algorithm's) ability to measure parameters directly, independent of human interpretation of the results beyond standard quality control.

7. The Type of Ground Truth Used

The type of ground truth used is implicit in the nature of hematology analyzers:

For parameters like WBC, RBC, HGB, etc., the ground truth would typically be established by reference methods or calibrated controls that are considered highly accurate.
For the body fluid mode, the "manufacturer's specifications" would define the expected accurate values against which the device's measurements (Accuracy, Precision, Linearity, Carryover) are compared. These specifications are likely derived from internal validation studies using reference methods.

8. The Sample Size for the Training Set

The document does not provide information regarding a training set. As this is an automated hematology analyzer performing quantitative measurements based on established physical and chemical principles (RF/DC Detection, Sheath Flow DC Detection, Flow Cytometry), traditional machine learning "training sets" are not typically a primary focus for regulatory submissions of this type. The device's "training" would involve the design and calibration of its internal algorithms and measuring channels.

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

Since a traditional "training set" for a machine learning model is not explicitly mentioned as relevant in this context, the method for establishing its ground truth is not applicable/provided. The device's operational principles are based on known physics and established clinical measurement techniques.

Summary

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5. 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: K112605

1. Submitted by:	Sysmex America, Inc.One Nelson C. White ParkwayMundelein, IL. 60060Phone: (847) 996-4618; FAX: (847) 996-4655Contact person: Sharita BrooksDate prepared: August 31, 2011
2. Name of Device:	Trade or proprietary name: Sysmex® XN-Series (XN-10, XN-20)Common name: Automated Hematology AnalyzerClassification name: Automated Differential Cell Counter 21 CFR 864.5220 is aClass II device. Product Code: GKZRelated Items:Product Code: 81GIFCELLPACKTM DCL (Diluent)CELLPACKTM DFL (Diluent)Product Code: 81GGKLYSERCELL WNR (Lyse)LYSERCELL WDF (Lyse)LYSERCELL WPC (Lyse)Product Code: 81KJKFLUOROCELL WNR (Stain)FLUOROCELL WDF (Stain)FLUOROCELL RET (Stain)FLUOROCELL PLT (Stain)FLUOROCELL WPC (Stain)Product Code: 81KSAXN CAL (Calibrator)XN CAL PF (Calibrator)Product Code: 81JPKXN-Check (Control)XN-Check BF (Control)Analyzer ComponentsSA-10 (Auto Sampler for single module)SA-20 (Auto Sampler for two modules)IPU (Information Processing Unit)
3. Predicate Device:	Sysmex® XE-5000Automated Hematology Analyzer
4. Device Description:	The Sysmex® XN-Series modules (XN-10, XN-20) are multi-parameter hematologyanalyzers intended to perform tests on whole blood samples collected in K₂ orK₃EDTA and body fluids (pleural, peritoneal and synovial) collected in K₂anticoagulant. It can also perform tests on CSF which should not be collected in anyanticoagulant. The instrument consists of four principal units: (1) Two Main Units(XN-10, XN-20) which aspirate, dilute, mix, and analyze blood and body fluidsamples; (2) Two Auto Sampler Units (SA-10, SA-20) which supply samples to theMain Unit automatically; (3) IPU (Information Processing Unit) which processesdata from the Main Unit and provides the operator interface with the system; (4)Pneumatic Unit which supplies pressure and vacuum from the Main Unit. The XN-Series analyzers perform analysis using the following methods: RF/DC DetectionMethod, Sheath Flow DC Detection Method, and Flow Cytometry Methods using aSemiconductor Laser. Particle characterization and identification is based ondetection of forward scatter, fluorescence and adaptive cluster analysis. The XN-Series analyzers automatically classify cells from whole blood and body fluids andcarry out all processes automatically from aspiration of the sample to outputting theresults.The body fluid analysis mode of the XN-Series analyzers uses the 4DIFFscattergram & the RBC distribution obtained from a specialized analysis sequence tocalculate & display the WBC (WBC-BF) counts, mononuclear cell (MN) /polymorphonuclear cell (PMN) counts & 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.
5. Intended Use:	The XN-Series modules (XN-10, XN-20) are quantitative multi-parameterautomated hematology analyzers intended for in vitro diagnostic use in screeningpatient populations found in clinical laboratories.
	The XN-Series modules classify and enumerate the following parameters in wholeblood: 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, IRF, RET-He and has a Body Fluidmode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF,MN%/#, PMN%/#, and TC-BF parameters in cerebrospinal fluid (CSF), serousfluids (peritoneal, pleural) and synovial fluids. Whole blood should be collected inK₂ or K₃EDTA anticoagulant and, Serous and Synovial fluids in K₂EDTAanticoagulant to prevent clotting of fluid. The use of anticoagulants with CSFspecimens is neither required nor recommended.
6. Substantial equivalence-similarities and differences	The following table compares the XN-Series modules (XN-10, XN-20) AutomatedHematology analyzers with the XE-5000 Automated Hematology analyzer.
7. Clinical PerformanceData:	Studies were performed to evaluate the equivalency of the XN-Series AutomatedHematology analyzers (Modules XN-10, XN-20) to the XE-5000 AutomatedHematology analyzer. Results indicated equivalent performance.

Sysmex XN-Series modules (XN-10, XN-20) Automated Hematology Analyzers 510(k) Submission OCT 1 9 2012

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Sysmex XN-Series modules (XN-10, XN-20)
Automated Hematology Analyzers 510(k) Submission

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Table 1: Substantial Equivalence – Similarities and Differences to the XN-Series Automated Hematology analyzers (Modules XN-10, XN-20) and XE-5000 Automated Hematology analyzer.

Features(Submission #)	Predicate XE-5000(K071967)	XN-Series(XN-10, XN-20)
FDA Clearance	20-Nov-07
Intended Use	XE-5000	XN-10	XN-20
	Sysmex® XE-5000 is an	The Sysmex® XN-10	The Sysmex® XN-20 module is
	automated hematology	module is a quantitative	a quantitative multi-parameter
	analyzer for in vitro	multi-parameter automated	automated hematology analyzer
	diagnostic use in screening	hematology analyzer	intended for in vitro diagnostic
	patient populations found in	intended for in vitro	use in screening patient
	clinical laboratories. The	diagnostic use in screening	populations found in clinical
	XE-5000 classifies and	patient populations found in	laboratories. The XN-Series
	enumerates the same	clinical laboratories. The	modules classify and enumerate
	parameters as the XE-2100	XN-Series modules classify	the following parameters in
	using whole blood asdescribed below, cord blood	and enumerate the followingparameters in whole blood:	whole blood: WBC, RBC,HGB, HCT, MCV, MCH,
	for HPC and has a body fluid	WBC, RBC, HGB, HCT,	MCHC, PLT (PLT-I, PLT-F),
	mode for body fluids. The	MCV, MCH, MCHC, PLT	NEUT%/#, LYMPH%/#,
	Body Fluid mode analyzes	(PLT-I, PLT-F), NEUT%/#,	MONO%/#, EO%/#,
	WBC-BF, RBC-BF,	LYMPH%/#, MONO%/#,	BASO%/#, IG%/#, RDW-CV,
	MN%/#, PMN%/# and TC-	EO%/#, BASO%/#, IG%/#,	RDW-SD, MPV, NRBC#/%,
	BF in body fluids	RDW-CV, RDW-SD, MPV,	RET%/#, IPF, IRF, RET-He
	(cerebrospinal fluids (CSF),	NRBC#/%, RET%/#, IPF,	and has a Body Fluid mode for
	serous fluids, and synovial	IRF, RET-He and has a Body	body fluids. The Body Fluid
	fluids with EDTA, as	Fluid mode for body fluids.	mode enumerates the WBC-BF.
	needed).	The Body Fluid mode	RBC-BF, MN%/#, PMN%/#,
	WBC, RBC, HGB, HCT,	enumerates the WBC-BF,	and TC-BF parameters in
	MCV, MCH, MCHC, PLT,	RBC-BF, MN%/#, PMN%/#,	cerebrospinal fluid (CSF),
	NEUT% / #, LYMPH% / #,	and TC-BF parameters in	serous fluids (peritoneal,
	MONO% / #, EO% / #,BASO% / #, NRBC% / #,	cerebrospinal fluid (CSF),	pleural) and synovial fluids.Whole blood should be
	RDW-SD, RDW-CV, MPV,	serous fluids (peritoneal,pleural) and synovial fluids.	collected in K2 or K3EDTA
	RET% / #, IRF, IG% / #,	Whole blood should be	anticoagulant and, Serous and
	RET-He, IPF, HPC	collected in K2 or K3EDTA	Synovial fluids in K2EDTA
	WBC-BF, RBC-BF,	anticoagulant and, Serous	anticoagulant to prevent clotting
	MN% / #, PMN%/ #,	and Synovial fluids in	of fluid. The use of
	TC-BF#.	K2EDTA anticoagulant to	anticoagulants with CSF
		prevent clotting of fluid. The	specimens is neither required
		use of anticoagulants with	nor recommended.
		CSF specimens is neither
		required nor recommended.
		SIMILARITIES
Sample Type	Whole bloodBody Fluids	Whole BloodBody Fluids	Whole BloodBody Fluids
Principles	Performs hematologyanalyses according to theHydro Dynamic Focusing(DC Detection), flowcytometry method (using a	SAME	SAME
	SLS-hemoglobin method.
Parameters	Whole Blood Mode:WBC, RBC, HGB, HCT,MCV, MCH, MCHC, PLT,NEUT%/#, LYMPH%/#,MONO%/#, EO%/#,BASO%/#, NRBC%/#,RDW-CV, RDW-SD, MPV,RET%/#, IRF, IG%/#, RET-He#, IPF.Body Fluid Mode:WBC-BF, RBC-BF,MN%/#, PMN%/#, TC-BF#	Whole Blood Mode:WBC, RBC, HGB, HCT,MCV, MCH, MCHC, PLT(PLT-I, PLT-F), NEUT%/#,LYMPH%/#, MONO%/#,EO%/#, BASO%/#,NRBC%/#, RDW-CV,RDW-SD, MPV, RET%/#,IRF, IG%/#, RET-He#, IPF.Body Fluid Mode:WBC-BF, RBC-BF,MN%/#, PMN%/#, TC-BF#	Whole Blood Mode:WBC, RBC, HGB, HCT, MCV,MCH, MCHC, PLT (PLT-I,PLT-F), NEUT%/#,LYMPH%/#, MONO%/#,EO%/#, BASO%/#, NRBC%/#,RDW-CV, RDW-SD, MPV,RET%/#, IRF, IG%/#, RET-He#, IPF.Body Fluid Mode:WBC-BF, RBC-BF, MN%/#,PMN%/#, TC-BF#
Reagents	SULFOLYSER (Lyse)	SAME	SAME
Principles	Performs hematologyanalysis according to theRF/DC detection method,Hydro Dynamic Focusing(DC Detection), flowcytometry method (using asemiconductor laser), andSLS hemoglobin method.	SAME	SAME
Modes ofOperation	Sampler Analysis ModeManual Closed AnalysisModeBody Fluid AnalysisMode	SAME	SAME
MeasuringChannels	RET/PLT	SAME	SAME
EquivalencyData	Proven performance in FDAsubmission	Data consisting of Accuracy,Precision, Linearity andCarryover were collected toshow performance to themanufacturer's specificationfor the Body Fluid mode.This analysis supports theclaim that the XN-10analyzer is substantiallyequivalent to the XE-5000.	Data consisting of Accuracy,Precision, Linearity andCarryover were collected toshow performance to themanufacturer's specification forthe Body Fluid mode. Thisanalysis supports the claim thatthe XN-20 analyzer issubstantially equivalent to theXE-5000.
	DIFFERENCES
	Predicate XE-5000(K071967)		XN-Series(XN-10, XN-20)
Item		XN-10	XN-20
Controls &Calibrators	Whole Bloode-Check (XE) - 3 LevelsWhole Blood StabilityUnopened 84 days	Whole Blood*XN-Check - 3 LevelsWhole Blood StabilityUnopened 84 days	Whole Blood*XN-Check - 3 LevelsWhole Blood StabilityUnopened 84 days
	XE Calibrator	*XN-10 Calibrator	*XN-20 Calibrator
	(X CAL)	(XN CAL)	(XN CAL)
	Not Available	Platelet F Calibrator(XN CAL PF)	Platelet F Calibrator(XN CAL PF)
	Not Available	Body FluidXN Check BF -- 2 Levels*Product name changeonly.	Body FluidXN Check BF - 2 Levels*Product name change only.
IPU	Single Module connect	Multi-Module connect	Multi-Module connect
Modes of Operation	Manual Open Cap AnalysisMode(Operator presents sampleto aspiration needle)	Manual Open CapAnalysis Mode(Sample placed in tubeholder position)	Manual Open Cap AnalysisMode(Sample placed in tube holderposition)
	Capillary Analysis ModeDilute sample 1:5	Pre-dilute Analysis ModeDilute sample 1:7	Pre-dilute Analysis ModeDilute sample 1:7
	Not Available	Low WBC Mode (LWBC)	Low WBC Mode(LWBC)
Sample Type	Umbilical Cord Blood	Not Available	Not Available
Parameters	HPC	Not Available	Not Available
Sample Aspiration/Fluidic Pathway	Two pathways	Single pathway	Single pathway
Dimensions of MainUnit (IncludingSampler Unit)	Width: 706mmHeight: 711mmDepth: 912mm	Width: 645mmHeight: 855mmDepth: 755mm(Single Unit)	Width: 645mmHeight: 855mmDepth: 755mm(Single Unit)
Weight (kg)Including Sampler	93(Single Unit)	78(Single Unit)	78(Single Unit)
Software/Hardware	No Rules-based rerun /reflex	Rules-based rerun / reflex	Rules-based rerun / reflex
Throughput	Whole BloodApproximately 113-150depending on mode used.	Whole Blood100 samples/hourmaximumdepending on mode used.	Whole Blood100 samples/hour maximumdepending on mode used.
	Body Fluid38 samples/hour	Body Fluid40 samples/hour maximum	Body Fluid40 samples/hour maximum
Measuring Channels(see Section 11 fordetailed informationon these channels)	WBC/BASODIFFNRBCIMINot Available	WNRWDFWNRNot AvailablePLT-F	WNRWDFWNRWPCPLT-F
Reagents	CELLPACKTM (Diluent)CELLSHEATHTM (Diluent)STROMATOLYSER-FBTM	CELLPACKTM DCL(Diluent)CELLPACKTM DFL	CELLPACKTM DCL (Diluent)CELLPACKTM DFL (Diluent)LYSERCELL WNR (Lyse)
	(Lyse)	(Diluent)	LYSERCELL WDF (Lyse)
	STROMATOLYSER-4DLTM (Lyse)	LYSERCELL WNR(Lyse)	FLUOROCELL WNR (Stain)
	STROMATOLYSER-4DSTM (Stain)	LYSERCELL WDF(Lyse)	FLUOROCELL WDF (Stain)
	STROMATOLYSER-NRTM(Diluent)	FLUOROCELL WNR(Stain)	FLUOROCELL RET (Stain)
	STROMATOLYSER-NRTM(Stain)	FLUOROCELL WDF(Stain)	FLUOROCELL PLT (Stain)
	RET-SEARCH II (Diluent)	FLUOROCELL RET(Stain)	LYSERCELL WPC (Lyse)
	RET-SEARCH II (Stain)	FLUOROCELL PLT(Stain)	FLUOROCELL WPC (Stain)
	STROMATOLYSER-IMTM (Lyse)
Sample AspirationVolume	Sampler Mode – 200µLManual (Closed Cap) Mode -200µLManual (Open Cap) Mode -130µLCapillary Mode - 130µLBody Fluid Mode - 130µL	Sampler Mode – 88µLManual (Closed Cap)Mode - 88µLManual (Open Cap) Mode -88µLDilution Mode - 70µLBody Fluid Mode - 88µL	Sampler Mode – 88µLManual (Closed Cap) Mode -88µLManual (Open Cap) Mode -88µLDilution Mode - 70µLBody Fluid Mode - 88µL

Sysmex XN-Series modules (XN-10, XN-20) Automated Hematology Analyzers 510(k) Submission

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Sysmex XN-Series modules (XN-10, XN-20)
Automated Hematology Analyzers 510(k) Submission

. •

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Sysmex XN-Series modules (XN-10, XN-20)

Automated Hematology Analyzers 510(k) Submission

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Sysmex XN-Series modules (XN-10, XN-20) Automated Hematology Analyzers 510(k) Submission

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image contains a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of flowing lines, giving it a dynamic and modern appearance. The seal is black and white.

10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 19 2012

Sysmex America, Inc. c/o Ms. Sharita Brooks Clinical Affairs Specialist II 577 Aptakisic Road Lincolnshire, IL 60069

Re: K112605

Trade/Device Name: Sysmex® XN-Series (XN-10, XN-20) Automated Hematology Analyzers Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: October 15, 2012 Received: October 16, 2012

Dear Ms. Brooks:

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.

If your device is classified (see above) into class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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Page 2 - Ms. Sharita Brooks

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in you Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Maria m chan

Maria M. Chan, Ph.D Director Division Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known)

Device Name: XN-Series (XN-10, XN-20) Automated Hematology Analyzers

Indications for Use:

The XN-Series modules classify and enumerate the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-F), NEUT%H, LYMPH%H, MONO%#, EO%#, BAS0%/#, 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, RNC-BF, MN%H, 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 with CSF specimens is neither required nor recommended.

Prescription Use X (Part 21 CFR 801 Subpart D)

Automated Hematology Analyzers 510(k) Submission

AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD

Division Sign-Off

Sysmex XN-Series modules (XN-10, XN-20)

Office of In Vitro Diagnostic
Device Evaluation and Safety

ﺔ ﺍﻟﻤ

510(k) K112605

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.”