SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES

K061150 · Sysmex America, Inc. · GKZ · Jul 6, 2006 · Hematology

Device Facts

• Record ID: K061150
• Device Name: SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES
• Applicant: Sysmex America, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Jul 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The Sysmex® XT-Series Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories. The XT- Series Body Fluid Application adds a quantitative, automated procedure for analyzing body fluids such as cerebrospinal fluid, serous fluid and synovial fluid to the XT- Series, providing enumeration of the WBCs and the RBCs.

Device Story

The XT-Series Body Fluid Application is an automated software/reagent update for the Sysmex XT-Series Hematology Analyzer; it enables quantitative analysis of body fluids (CSF, serous, synovial). The device uses fluorescent flow cytometry (lateral scatter/fluorescence) for WBC counts and Direct Current (DC) detection for RBC counts. It is operated by laboratory personnel in clinical settings. The system processes samples to provide automated cell counts, which are displayed to the clinician. These outputs assist in the clinical assessment of body fluid samples, replacing or supplementing manual counting methods. The application provides standardized, reproducible cell enumeration, reducing the subjectivity and labor associated with manual microscopy.

Clinical Evidence

Clinical performance was established by comparing the XT-Series Body Fluid Application to the predicate XE-2100 Series Body Fluid Application. Studies demonstrated excellent correlation between the two methods, confirming equivalent performance for the enumeration of WBCs and RBCs in body fluids.

Technological Characteristics

Automated hematology analyzer utilizing flow cytometry principles. Sensing involves side scatter, forward scatter, and fluorescent intensity of nucleated cells. Reagents include Cellpack, Sulfolyser, Stromatolyser-FB, Stromatolyser-4DL, Stromatolyser-4DS, and Ret-Search II. The system is designed for clinical laboratory use.

Indications for Use

Indicated for use in clinical laboratories for quantitative, automated analysis of body fluids (cerebrospinal, serous, and synovial) to provide enumeration of white blood cells (WBCs) and red blood cells (RBCs).

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 XE-Series Body Fluid Application (K061150)

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in The sammer of the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:

| 1. Submitted by: | Sysmex America, Inc.<br>One Nelson C. White Parkway<br>Mundelein, IL 60060<br>Phone: [phone]; FAX: [phone]<br>Contact person: Nina Gamperling<br>Date prepared: April 24, 2006 |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device: | Trade or proprietary name: Sysmex® Automated Hematology<br>Analyzer, XT- Series<br><br>Common name: Automated Hematology Analyzer.<br><br>Classification name: Sysmex® XT-Series, Automated<br>Hematology, an Automated Differential Cell Counter (21 CFR<br>864.5220) is a Class II medical device. |
| 3. Predicate Method: | The Sysmex® XT- Series Body Fluid Application claims<br>substantial equivalence to the Sysmex XE-Series Body Fluid<br>Application |
| 4. Device Description: | The XT-Series is an automated hematology analyzer previously<br>cleared by the FDA. The combination of side scatter, forward<br>scatter, and fluorescent intensity of nucleated cells gives an image<br>of each cell detected in the specimen. |
| 5. Intended Use: | The Sysmex® XT-Series Hematology Analyzer is a quantitative,<br>automated hematology analyzer and leukocyte differential<br>counter for <i>in vitro</i> diagnostic use in clinical laboratories. The<br>XT- Series Body Fluid Application adds a quantitative,<br>automated procedure for analyzing body fluids such as<br>cerebrospinal fluid, serous fluid and synovial fluid to the XT-<br>Series, providing enumeration of the WBCs and the RBCs. |
| 6. Substantial<br>equivalence-similarities<br>and differences | The following table compares the XT- Series Body Fluid<br>Application with the predicate method, XE-Series Body Fluid<br>Application. |

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

| | Predicate Method | New Instrument Method |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| | XE-2100 Series Body Fluid<br>Application | XT- Series Body Fluid Application |
| Intended Use | To provide a quantitative<br>determination of blood cells in<br>body fluids such as cerebrospinal<br>fluid, serous fluid and synovial<br>fluid. | Same as predicate method |
| Methodology | Cell count is performed on an<br>automated hematology analyzer. | Same as predicate method |
| Reagents | Cellpack, Sulfolyser,<br>Stromatolyser-FB,<br>Stromatolyser-4DL,<br>Stromatolyser-4DS,<br>Stromatolyser, NR,<br>Stromatolyser-IM,<br>Cellsheath<br>Ret-Search II | Cellpack, Sulfolyser,<br>Stromatolyser-FB,<br>Stromatolyser-4DL,<br>Stromatolyser-4DS,<br>Ret-Search II |
| Specimen Type | Body Fluids such as<br>Cerebrospinal fluid, Serous fluid,<br>Synovial fluid | Same as predicate method |
| Accuracy | Performance was established in<br>the previous 510(k) submission. | Comparison to the XE-2100 Series Body<br>Fluid Application demonstrated excellent<br>correlation |

## Comparison to Predicate Method

7. Clinical Performance Data: Studies were performed to evaluate the equivalency of the automated method to the predicate method. Results indicated equivalent performance.

8. Conclusions: ______________________________________________________________________________________________________________________________________________________________________________

The performance data demonstrated substantial equivalence.

:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the branches of government. The caduceus is surrounded by a circle of text that reads "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES, USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Nina M. Gamperling, MBA, MT (ASCP), RAC Manager, Regulatory Affairs Sysmex Corporation of America One Nelson C. White Parkway Mundelein, Illinois 60060

JUL - 6 2006

Re: k061150 Trade/Device Name: Sysmex® XT-Series, Automated Hematology Analyzer. Body Fluid Application Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: April 24, 2006 Received: April 25, 2006

Dear Ms. Gamperling:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Robert Beckerh

Robert L. Becker, Jr., MD, Pr Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

K061150 510(k) Number (if known):

Device Name: Sysmex® XT- Series, Automated Hematology Analyzer

Indications For Use:

The Sysmex® XT-Series Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories. The XT- Series Body Fluid Application adds a quantitative, automated procedure for analyzing body fluids such as cerebrospinal fluid, serous fluid and synovial fluid to the XT - Series, providing enumeration of the WCC and the RBCs.

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Concurrence of CIIRD, Office of Device Evaluation (ODE)

| Prescription Use | ✓ |
|------------------|----------------------|
| | OR |
| | Over-The-Counter Use |
| | Division Sign-Off |

Office of In Vitro Diagnostic Device Evaluation and Safety

| Body Fluid Application on Sysmex XT Series | |
|--------------------------------------------|---------|
| 510(k) FDA Submission | K061150 |

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