Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions "adaptive cluster analysis" for particle characterization and identification, which is a statistical method, not necessarily AI/ML. There are no explicit mentions of AI, ML, deep learning, or training/test data sets, which are common indicators of AI/ML use in medical devices.

Therapeutic

No
This device is an in vitro diagnostic hematology analyzer used for screening and quantifying parameters in blood and body fluids, not for treating any medical condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use".

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple hardware components including Main Units, Auto Sampler Units, an IPU (Information Processing Unit), and a Pneumatic Unit, all of which are integral to the device's function of aspirating, diluting, mixing, and analyzing samples.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "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."

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 (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.

Product codes

GKZ, 81GIF, 81GGK, 81KJK, 81KSA, 81JPK

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.

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

Not Found

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Data consisting of Accuracy, Precision, Linearity and Carryover were collected to show performance to the manufacturer's specification for the Body Fluid mode. This analysis supports the claim that the XN-10 analyzer is substantially equivalent to the XE-5000.

Data consisting of Accuracy, Precision, Linearity and Carryover were collected to show performance to the manufacturer's specification for the Body Fluid mode. This analysis supports the claim that the XN-20 analyzer is substantially equivalent to the XE-5000.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K071967

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.”

Summary

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Page 1 of 1

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 Parkway
Mundelein, IL. 60060
Phone: (847) 996-4618; FAX: (847) 996-4655
Contact person: Sharita Brooks
Date prepared: August 31, 2011 |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device: | Trade or proprietary name: Sysmex® XN-Series (XN-10, XN-20)
Common name: Automated Hematology Analyzer
Classification name: Automated Differential Cell Counter 21 CFR 864.5220 is a
Class II device. Product Code: GKZ
Related Items:
Product Code: 81GIF
CELLPACKTM DCL (Diluent)
CELLPACKTM DFL (Diluent)
Product Code: 81GGK
LYSERCELL WNR (Lyse)
LYSERCELL WDF (Lyse)
LYSERCELL WPC (Lyse)
Product Code: 81KJK
FLUOROCELL WNR (Stain)
FLUOROCELL WDF (Stain)
FLUOROCELL RET (Stain)
FLUOROCELL PLT (Stain)
FLUOROCELL WPC (Stain)
Product Code: 81KSA
XN CAL (Calibrator)
XN CAL PF (Calibrator)
Product Code: 81JPK
XN-Check (Control)
XN-Check BF (Control)
Analyzer Components
SA-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 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. |
| 5. 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 (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. |
| 6. Substantial equivalence-
similarities and differences | The following table compares the XN-Series modules (XN-10, XN-20) Automated
Hematology analyzers with the XE-5000 Automated Hematology analyzer. |
| 7. Clinical Performance
Data: | 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. |

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

1

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

12

2

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 as
described below, cord blood | and enumerate the following
parameters 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 blood
Body Fluids | Whole Blood
Body Fluids | Whole Blood
Body Fluids |
| Principles | Performs hematology
analyses according to the
Hydro Dynamic Focusing
(DC Detection), flow
cytometry 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 hematology
analysis according to the
RF/DC detection method,
Hydro Dynamic Focusing
(DC Detection), flow
cytometry method (using a
semiconductor laser), and
SLS hemoglobin method. | SAME | SAME |
| Modes of
Operation | Sampler Analysis Mode
Manual Closed Analysis
Mode
Body Fluid Analysis
Mode | SAME | SAME |
| Measuring
Channels | RET/PLT | SAME | SAME |
| Equivalency
Data | Proven performance in FDA
submission | Data consisting of Accuracy,
Precision, Linearity and
Carryover were collected to
show performance to the
manufacturer's specification
for the Body Fluid mode.
This analysis supports the
claim that the XN-10
analyzer is substantially
equivalent to the XE-5000. | Data consisting of Accuracy,
Precision, Linearity and
Carryover were collected to
show performance to the
manufacturer's specification for
the Body Fluid mode. This
analysis supports the claim that
the XN-20 analyzer is
substantially equivalent to the
XE-5000. |
| | DIFFERENCES | | |
| | Predicate XE-5000
(K071967) | | XN-Series
(XN-10, XN-20) |
| Item | | XN-10 | XN-20 |
| Controls &
Calibrators | Whole Blood
e-Check (XE) - 3 Levels
Whole Blood Stability
Unopened 84 days | Whole Blood
*XN-Check - 3 Levels
Whole Blood Stability
Unopened 84 days | Whole Blood
*XN-Check - 3 Levels
Whole Blood Stability
Unopened 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 Fluid
XN Check BF -- 2 Levels
*Product name change
only. | Body Fluid
XN Check BF - 2 Levels
*Product name change only. |
| IPU | Single Module connect | Multi-Module connect | Multi-Module connect |
| Modes of Operation | Manual Open Cap Analysis
Mode
(Operator presents sample
to aspiration needle) | Manual Open Cap
Analysis Mode
(Sample placed in tube
holder position) | Manual Open Cap Analysis
Mode
(Sample placed in tube holder
position) |
| | Capillary Analysis Mode
Dilute sample 1:5 | Pre-dilute Analysis Mode
Dilute sample 1:7 | Pre-dilute Analysis Mode
Dilute 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 Main
Unit (Including
Sampler Unit) | Width: 706mm
Height: 711mm
Depth: 912mm | Width: 645mm
Height: 855mm
Depth: 755mm
(Single Unit) | Width: 645mm
Height: 855mm
Depth: 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 Blood
Approximately 113-150
depending on mode used. | Whole Blood
100 samples/hour
maximum
depending on mode used. | Whole Blood
100 samples/hour maximum
depending on mode used. |
| | Body Fluid
38 samples/hour | Body Fluid
40 samples/hour maximum | Body Fluid
40 samples/hour maximum |
| Measuring Channels
(see Section 11 for
detailed information
on these channels) | WBC/BASO
DIFF
NRBC
IMI
Not Available | WNR
WDF
WNR
Not Available
PLT-F | WNR
WDF
WNR
WPC
PLT-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 Aspiration
Volume | Sampler Mode – 200µL
Manual (Closed Cap) Mode -
200µL
Manual (Open Cap) Mode -
130µL
Capillary Mode - 130µL
Body Fluid Mode - 130µL | Sampler Mode – 88µL
Manual (Closed Cap)
Mode - 88µL
Manual (Open Cap) Mode -
88µL
Dilution Mode - 70µL
Body Fluid Mode - 88µL | Sampler Mode – 88µL
Manual (Closed Cap) Mode -
88µL
Manual (Open Cap) Mode -
88µL
Dilution Mode - 70µL
Body 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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. •

4

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

Automated Hematology Analyzers 510(k) Submission

5

:

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

:

6

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

7

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

8

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 (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-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