Predicate Devices

Sysmex® XT-Series,Sysmex® XE-5000,Body Fluid Mode

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard automated hematology analyzer and its operational components. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The focus is on standard hematological analysis techniques and comparison to predicate devices.

Therapeutic

No
The device is an in vitro diagnostic hematology analyzer used for screening and enumerating blood and body fluid parameters, not for treating or preventing disease.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that "The Sysmex® XT-4000i is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories."

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple hardware components (Main Unit, Sampler Unit, IPU, Pneumatic Unit) that are integral to the device's function as an automated hematology analyzer. While it includes an Information Processing Unit (IPU), this unit processes data from the hardware and provides the interface, indicating it's part of a larger hardware system, not a standalone software device.

IVD (In Vitro Diagnostic)

Yes, the Sysmex® XT-4000i is an IVD (In Vitro Diagnostic) device.

Here's why:

Explicit Statement in Intended Use: The very first sentence of the "Intended Use / Indications for Use" section clearly states: "The Sysmex® XT-4000i is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories." This is the most direct confirmation.
Analysis of Biological Samples: The device analyzes whole blood and body fluids (cerebrospinal fluids, serous fluids, synovial fluids). These are biological samples taken from the human body.
Quantitative Measurement of Parameters: The device provides quantitative measurements of various hematological parameters (WBC, RBC, HGB, etc.) and body fluid parameters (WBC-BF, RBC-BF, etc.). These measurements are used to provide information about a patient's health status.
Use in Clinical Laboratories: The intended use specifies that the device is for use in clinical laboratories, which are settings where diagnostic testing is performed.

All of these characteristics align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Sysmex® XT-4000i is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XT-4000i classifies and enumerates the following parameters for whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, 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 fluids (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Serous and Synovial fluids should be collected in K2EDTA to prevent clotting of fluid. The use of anticoagulants with CSF specimens is not required or recommended.

Product codes

GKZ

Device Description

The XT-4000 is the same as the XT-2000 which is part of the XT-Series and has a Body Fluid mode the same as the XE-5000. It is an automated hematology analyzer which consists of four principle units: (1) Main Unit which aspirates, dilutes, mixes, and analyzes whole blood and body fluid samples; (2) Sampler Unit which supplies 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 Body Fluid analysis mode of the XT-4000 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.

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

In 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

Studies were performed to evaluate the equivalency of the XT-4000 to the XE-5000 Body Fluid Mode. Results indicated equivalent performance.
Data consisting of Accuracy, Precision, Linearity and Carryover was collected to show performance to the manufacturer's specification for the Body Fluid mode. This analysis supports the claim that the XT-4000i Body Fluid mode is substantially equivalent to the XE-5000 Body Fluid mode.

Key Metrics

Not Found

Predicate Device(s)

Sysmex® XT-Series, Sysmex® XE-5000, Body Fluid Mode

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

0

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: K091313_______________________________________________________________________________________________________________________________________

| 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: April 30, 2009 |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device: | Trade or proprietary name: Sysmex® XT-4000
Common name: Automated Hematology Analyzer
Classification name: Automated Differential Cell Counter
21 CFR 864.5220 |
| 3. Predicate Device: | Sysmex® XT-Series
Sysmex® XE-5000, Body Fluid Mode |
| 4. Device Description: | The XT-4000 is the same as the XT-2000 which is part of the XT-
Series and has a Body Fluid mode the same as the XE-5000. It is an
automated hematology analyzer which consists of four principle units:
(1) Main Unit which aspirates, dilutes, mixes, and analyzes whole blood
and body fluid samples; (2) Sampler Unit which supplies 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 Body Fluid analysis mode of the XT-4000 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. |
| 5. Intended Use: | The Sysmex® XT-4000 is a quantitative multi-parameter automated
hematology analyzer intended for in vitro diagnostic use in screening
patient populations found in clinical laboratories. The XT-4000
classifies and enumerates the following parameters for whole blood:
WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#,
LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV,
RDW-SD, MPV, RET%/#, 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 fluids
(CSF), serous fluids (peritoneal, pleural) and synovial fluids. Serous
and Synovial fluids should be collected in K2EDTA to prevent clotting
of fluid. The use of anticoagulants with CSF specimens is not required
or recommended. |
| 6. Substantial equivalence-
similarities and differences | The following table compares the XT-4000 with the XT-Series and the
XE-5000 Body Fluid Mode. |
| 7. Clinical Performance
Data: | Studies were performed to evaluate the equivalency of the XT-4000 to
the XE-5000 Body Fluid Mode. Results indicated equivalent
performance. |
| 8. Conclusions: | The performance data demonstrated substantial equivalence. |

Sysmex XT-4000i Automated Hematology Analyzer

510(k) FDA Submission

1

| Features
(Submission #) | XT-4000 i | XT-Series
(K021241)
25-June-02 | XE-5000
(K071967)
20-Nov-07 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Clearance | | | |
| Intended Use | The Sysmex® XT-4000 i is
a quantitative multi-
parameter automated
hematology analyzer
intended for in vitro
diagnostic use in screening
patient populations found
in clinical laboratories.
The XT-4000 i classifies
and enumerates the
following parameters for
whole blood: WBC, RBC,
HGB, HCT, MCV, MCH,
MCHC, PLT, NEUT%/#,
LYMPH%/#, MONO%/#,
EO%/#, BASO%/#,
IG%/#, RDW-CV, RDW-
SD, MPV, RET%/#, 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 fluids (CSF),
serous fluids (peritoneal,
pleural) and synovial
fluids. Serous and
Synovial fluids should be
collected in K₂EDTA to
prevent clotting of fluid.
The use of anticoagulants
with CSF specimens is not
required or recommended. | The Sysmex® XT-2000 i is
intended for in vitro
diagnostic use in the
clinical laboratory as a
multi-parameter
hematology analyzer.

The XT-2000 i has a Body
Fluid Application which
adds a quantitative,
automated procedure for
analyzing body fluids
(cerebrospinal fluids
(CSF), serous fluids, and
synovial fluids with
EDTA, as needed) to the
XT-2000 i , providing
enumeration of the WBCs
and the RBCs. | The Sysmex® XE-5000 is
an automated hematology
analyzer for in vitro
diagnostic use in screening
patient populations found
in clinical laboratories.

The XE-5000 has a Body
Fluid mode for body
fluids. The Body Fluid
mode analyzes WBC-BF,
RBC-BF, MN%/#,
PMN%/# and TC-BF# in
body fluids (cerebrospinal
fluids (CSF), serous fluids,
and synovial fluids with
EDTA, as needed). |
| Sample Type | Whole blood/Body Fluids | Whole blood/Body Fluids | Whole blood/Body Fluids |
| Parameters | WBC, RBC, HGB, HCT,
MCV, MCH, MCHC,
PLT, NEUT%/#,
LYMPH%/#, MONO%/#,
EO%/#, BASO%/#,
RDW-CV, RDW-SD,
MPV, RET%/#, IRF,
IG%/#, RET-He# | WBC, RBC, HGB, HCT,
MCV, MCH, MCHC,
PLT, NEUT%/#,
LYMPH%/#, MONO%/#,
EO%/#, BASO%/#,
RDW-CV, RDW-SD,
MPV, RET%/#, IRF,
IG%/#, RET-He# | WBC, RBC, HGB, HCT,
MCV, MCH, MCHC,
PLT, NEUT%/#,
LYMPH%/#, MONO%/#,
EO%/#, BASO%/#,
NRBC%/#,RDW-CV,
RDW-SD, MPV, RET%/#,
IRF, IG%/#, HPC#, RET-
He#, IPF. |
| | Body Fluid Mode:
WBC-BF, RBC-BF,
MN%/#, PMN%/#, TC- | Body Fluid Application:
WBC-BF, RBC-BF | Body Fluid Mode:
WBC-BF, RBC-BF,
MN%/#, PMN%/#, TC- |
| | BF# | | BF# |
| Reagents | CELLPACKTM (Diluent)
STROMATOLYSER-
FBTM (Lyse)
STROMATOLYSER-
4DLTM (Lyse)
STROMATOLYSER-
4DSTM (Stain)
SULFOLYSER (Lyse)
RET-SEARCH II
(Diluent)
RET-SEARCH II (Stain) | CELLPACKTM (Diluent)
STROMATOLYSER-
FBTM (Lyse)
STROMATOLYSER-
4DLTM (Lyse)
STROMATOLYSER-
4DSTM (Stain)
SULFOLYSER (Lyse)
RET-SEARCH II
(Diluent)
RET-SEARCH II (Stain) | CELLPACKTM (Diluent)
CELLSHEATHTM
(Diluent)
STROMATOLYSER-
FBTM (Lyse)
STROMATOLYSER-
4DLTM (Lyse)
STROMATOLYSER-
4DSTM (Stain)
STROMATOLYSER-
NRTM (Diluent)
STROMATOLYSER-
NRTM (Stain)
STROMATOLYSER-
IMTM (Lyse)
SULFOLYSER (Lyse)
RET-SEARCH II
(Diluent)
RET-SEARCH II (Stain) |
| Principles | Performs hematology
analyses according to
the Hydro Dynamic
Focusing (DC Detection),
flow cytometry
method (using a
semiconductor laser), and
SLS-hemoglobin
method. | Performs hematology
analyses according to
the Hydro Dynamic
Focusing (DC Detection),
flow cytometry
method (using a
semiconductor laser), and
SLS-hemoglobin
method. | 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. |
| Dimensions
(HxWxD) (mm) | 630x520x720 | 630x520x720 | 711x706x535 |
| Weight (kg) | 59 | 59 | 81 |
| Quality Control/
Calibrator | e-Check (XE) – 3 Levels
Calibrator (X Cal) | e-Check - 3 Levels
Calibrator (X Cal) | e-Check (XE) - 3 Levels
XE Calibrator (X Cal) |
| Software/
Hardware
Differences | The XT-4000i performs
the same as the XT-2000i
and has a Body Fluid
mode the same as the XE-
5000. | The XT-2000i does not
have a Body Fluid mode .
The XT-2000i has a Body
Fluid Application. | The XE-5000 has a Body
Fluid mode . |
| Throughput | Approx 80-100/hr
Depending on mode used. | Approx 80
Depending on mode used. | Approximately 113-150
depending on mode used. |
| Equivalency Data | Data consisting of Accuracy,
Precision, Linearity and
Carryover was collected to
show performance to the
manufacturer's specification
for the Body Fluid mode.
This analysis supports the
claim that the XT-4000i Body
Fluid mode is substantially
equivalent to the XE-5000
Body Fluid mode. | Proven performance in FDA
submission | Proven performance in FDA
submission |

Table 1: Substantial Equivalence – Similarities and Differences to the XT-Series and I

Sysmex XT-4000i Automated Hematology Analyzer
510(k) FDA Submission

2

ﺮ

Sysmex XT-4000i Automated Hematology Analyzer
510(k) FDA Submission

:

.

3

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Sysmex America, Inc. c/o Ms. Sharita Brooks, BBA, MT Clinical Affairs Specialist One Nelson C. White Parkway Mundelein, IL 60060

MAR 3 0 2010

Re: K091313

Trade/Device Name: Sysmex XT-4000i Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: March 18, 2010 Received: March 19, 2010

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

4

Page 2 - Ms. Sharita Brooks

medical device-related adverse events) (21 CFR 803); and good manufacturing practice 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 your 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 Diagnostic Device Evaluation and Safety 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/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 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.

Mana M Chan

Maria M. Chan. Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

5

Indications for Use Form

510(k) Number (if known) K091313

Device Name: XT-4000i, Automated Hematology Analyzer

Indications for Use:

The Sysmex® XT-4000i is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XT-4000i classifies and enumerates the following parameters for whole blood: WBC, RBC, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, 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 fluids (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Serous and Synovial fluids should be collected in K2EDTA to prevent clotting of fluid. The use of anticoagulants with CSF specimens is not required or recommended.

Prescription Use (Part 21 CFR 801 Subpart D) 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)

Seuk R.K.

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)	K091313
--------	---------

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