SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)

K040073 · Sysmex America, Inc. · GKZ · Mar 18, 2004 · Hematology

Device Facts

• Record ID: K040073
• Device Name: SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
• Applicant: Sysmex America, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Mar 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The Sysmex® XE-2100 Series Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Body Fluid Application adds a quantitative, automated procedure for analyzing cerebrospinal fluid, scrous fluid and synovial fluid to the XE-2100 Series, providing enumeration of the WBCs and the RBCs.

Device Story

The Sysmex XE-2100 Series is an automated hematology analyzer used in clinical laboratories by trained personnel. It processes body fluid specimens (cerebrospinal, serous, synovial) to provide quantitative counts of white blood cells (WBCs) and red blood cells (RBCs). The device utilizes flow cytometry principles, measuring side scatter, forward scatter, and fluorescent intensity of nucleated cells to identify and enumerate cell populations. This automated method replaces manual counting in a counting chamber, offering improved reproducibility and accuracy by reducing variability associated with technologist skill and manual labor. Healthcare providers use the resulting cell counts to assist in clinical decision-making regarding patient health status.

Clinical Evidence

Equivalency was demonstrated through comparative studies between the automated method and the manual counting predicate method. Results indicated equivalent performance, with the automated method providing more consistent and reproducible results than manual counting.

Technological Characteristics

Automated hematology analyzer utilizing flow cytometry. Sensing principle: forward scatter, side scatter, and fluorescent intensity of nucleated cells. System is designed for clinical laboratory use. Software-based automated analysis replaces manual microscopy.

Indications for Use

Indicated for use in clinical laboratories for the quantitative, automated enumeration of WBCs and RBCs in cerebrospinal, serous, and synovial fluids, and as a leukocyte differential counter.

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

• Standard method WBC/RBC counting using a hemacytometer and microscope
• Sysmex XE-2100 Series Automated Hematology Analyzer (K992875)

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 accordance with 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: January 13, 2004 |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device: | Trade or proprietary name: Sysmex® Automated Hematology<br>Analyzer, XE-2100 Series<br><br>Common name: Automated Hematology Analyzer.<br><br>Classification name: Sysmex® XE-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® XE-2100 Series Body Fluid Application claims<br>substantial equivalence to the pre-amendment predicate method<br>for the enumeration of WBCs and RBCs of manual cell counting<br>in a counting chamber by a skilled, competent technologist. |
| 4. Device Description: | The XE-2100 Series is an automated hematology analyzer<br>previously cleared by the FDA. The combination of side scatter,<br>forward scatter, and fluorescent intensity of nucleated cells gives<br>an image of each cell detected in the specimen. |
| 5. Intended Use: | The Sysmex® XE-2100 Series Hematology Analyzer is a<br>quantitative, automated hematology analyzer and leukocyte<br>differential counter For In Vitro Diagnostic Use in clinical<br>laboratories. The Body Fluid Application adds a quantitative,<br>automated procedure for analyzing cerebrospinal fluid, scrous<br>fluid and synovial fluid to the XE-2100 Series, providing<br>enumeration of the WBCs and the RBCs. |
| 6. Substantial<br>equivalence-similarities<br>and differences | The following table compares the XE-2100 Series Body Fluid<br>Application with the predicate method. |

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

| Comparison to Predicate Method | | XE-2100 Series Body Fluid Application |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Manual Method | Automated Method |
| Intended Use | To provide a quantitative<br>determination of blood cells in<br>cerebrospinal fluid, serous fluid<br>and synovial fluid. | Same as predicate method |
| Methodology | Cell count is performed manually<br>in a counting chamber by a skilled<br>competent technologist. | Cell count is performed on an automated<br>hematology analyzer. |
| Specimen Type | Cerebrospinal fluid, Serous fluid,<br>Synovial fluid | Same as predicate method |
| Performance | Method of cell counting using a<br>microscope established as the<br>predicate method. | Comparison to manual count showed<br>good correlation. |
| Pro/Con | The reproducibility and accuracy<br>of the manual method will vary<br>due to the differences in<br>technologist skill and experience.<br>It is a labor intensive and time-<br>consuming method. | The reproducibility and accuracy of an<br>automated method is more consistent<br>since this method is not subject to the<br>variation of the manual method. A large<br>number of cells can be analyzed and<br>several parameters (i.e. forward scatter<br>[FSC], side scatter [SSC], and fluorescent<br>labels) rather than morphological<br>appearance alone can be used to identify<br>the blood cells. |

### Comparison to Predicate Method

| 7. Clinical Performance Data: | Studies were performed to evaluate the equivalency of<br>the automated method to the predicate method. Results<br>indicated equivalent performance. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| 8. Conclusions: | The performance data demonstrated substantial<br>equivalence. |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 8 2004

Ms. Nina M. Gamperling Manager, Regulatory Affairs Sysmex America, Inc. One Nelson C. White Parkway Mundelein, IL 60060

Re: k040073

Trade/Device Name: Sysmex® XE-2100 Series, Automated Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: January 13, 2004 Received: January 16, 2004

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 for too battled in 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).

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If you desire specific information about the application of labeling requirements to your device, or you don't 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 Tou may ocann 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/dsma/dsmamain.html.

Sincerely yours,

Joseph L. Aralett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

K040073 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Sysmex® XE-2100 Series, Automated Hematology Analyzer

#### Indications For Use:

The Sysmex® XE-2100 Series Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Body Fluid Application adds a quantitative, automated procedure for analyzing cerebrospinal fluid, serous fluid and synovial fluid to the XE-2100 Series, providing enumeration of the WBCs and the RBCs.

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

Concurrence of CHRD, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

*signature*

**Division Sign-Off**

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Office of In Vitro Diagnostic Device Evaluation and Safety

Body Fluid Application on Sysmcx XE-2100 Series 510(k) FDA Submission

(k) K640073