Who is the manufacturer of SYSMEX MODEL XT-4000I?

Sysmex America, Inc. filed the 510(k) submission for SYSMEX MODEL XT-4000I (K091313).

What is the FDA product code for SYSMEX MODEL XT-4000I?

GKZ. It is classified under 21 CFR 864.5220 as a Class 2 device in the Hematology panel.

What is the regulatory pathway for SYSMEX MODEL XT-4000I?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SYSMEX MODEL XT-4000I?

Sysmex® XT-Series (K021241); Sysmex® XE-5000, Body Fluid Mode (K071967).

Who can help prepare an FDA 510(k) submission like SYSMEX MODEL XT-4000I?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SYSMEX MODEL XT-4000I

K091313 · Sysmex America, Inc. · GKZ · Mar 30, 2010 · Hematology

Device Facts

Record ID	K091313
Device Name	SYSMEX MODEL XT-4000I
Applicant	Sysmex America, Inc.
Product Code	GKZ · Hematology
Decision Date	Mar 30, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.5220
Device Class	Class 2

Intended 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.

Device Story

Automated hematology analyzer; processes whole blood and body fluid samples. Main unit aspirates, dilutes, mixes, and analyzes samples; sampler unit automates loading; IPU processes data/operator interface; pneumatic unit provides pressure/vacuum. Body Fluid (BF) mode uses 4DIFF scattergram and RBC distribution from specialized analysis sequence to calculate/display WBC-BF, RBC-BF, MN, PMN, and TC-BF counts. Used in clinical laboratories by trained personnel. Output displayed on IPU for clinical review; assists in hematological assessment and body fluid cell enumeration. Benefits include automated, standardized cell counting in body fluids, reducing manual microscopy requirements.

Clinical Evidence

Bench testing only. Studies evaluated accuracy, precision, linearity, and carryover for the Body Fluid mode. Results demonstrated performance equivalent to the XE-5000 Body Fluid mode.

Technological Characteristics

Automated hematology analyzer; dimensions 630x520x720mm; weight 59kg. Sensing: Hydrodynamic focusing (DC detection), flow cytometry (semiconductor laser), SLS-hemoglobin method. Reagents: CELLPACK, STROMATOLYSER-FB/4DL/4DS, SULFOLYSER, RET-SEARCH II. Connectivity: IPU for data processing and operator interface. Software: Automated analysis of scattergrams and distributions.

Indications for Use

Indicated for in vitro diagnostic screening of patients in clinical laboratories. Analyzes whole blood for hematological parameters and body fluids (CSF, serous, synovial) for cell counts (WBC-BF, RBC-BF, MN, PMN, TC-BF). Serous/synovial fluids require K2EDTA; CSF does not require anticoagulants.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

Sysmex® XT-Series (K021241)
Sysmex® XE-5000, Body Fluid Mode (K071967)

Related Devices

K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer · Sysmex America, Inc. · Jun 25, 2025
K160538 — Sysmex XN-L Automated Hematology Analyzer · Sysmex America, Inc. · Dec 22, 2016
K992875 — SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER · Sysmex Corp. · Nov 9, 1999

Submission Summary (Full Text)

{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 | |--------|---------| |--------|---------| Page 1 of 1

SYSMEX MODEL XT-4000I

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

SYSMEX MODEL XT-4000I

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!