SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES

K060656 · Sysmex America, Inc. · GKZ · May 10, 2006 · Hematology

Device Facts

• Record ID: K060656
• Device Name: SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES
• Applicant: Sysmex America, Inc.
• Product Code: GKZ · Hematology
• Decision Date: May 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The Sysmex® XS is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories.

Device Story

Sysmex XS is an automated hematology analyzer for clinical laboratory use. It processes peripheral blood samples collected in EDTA anticoagulant. The device utilizes sheath flow DC detection, flow cytometry with a semiconductor laser, and SLS-hemoglobin methodology to analyze blood components. It provides automated hematology test results to assist clinicians in diagnostic assessments. The system is operated by laboratory personnel. It serves as a diagnostic tool to provide accurate and precise hematological parameters, aiding in the evaluation of patient blood profiles.

Clinical Evidence

Clinical performance was established through comparative studies against the predicate Sysmex XE-2100 and XT-Series analyzers. Results demonstrated excellent correlation between the XS and the predicate devices for hematology parameters. No specific sensitivity, specificity, or AUC metrics were provided in the summary document.

Technological Characteristics

Automated hematology analyzer. Methods: Sheath Flow DC detection (RBC/PLT), semiconductor laser flow cytometry (WBC), SLS-hemoglobin (HGB). Connectivity: IPU interface. Software: Moderate Level of Concern. Modes: Sampler, Capillary, Manual.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to perform complete blood count (CBC) analysis on whole blood samples.

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-2100 (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: HOLOOLO 5 V

| 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: March 10, 2006 |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device: | Trade or proprietary name: Sysmex® XS, Automated<br>Hematology Analyzer.<br><br>Common name: XS<br><br>Classification name: Automated Differential Cell Counter,<br>Sysmex® XS-1000i and XS-800i (21 CFR 864.5220) |
| 3. Predicate Device: | The Sysmex® XS, Automated Hematology Analyzer, is<br>substantially equivalent to the Sysmex XE-2100 and Sysmex XT-<br>Series, Automated Hematology Analyzers. |
| 4. Device Description: | The XE-2000 and XT-Series are automated hematology analyzers<br>previously cleared by the FDA. |
| 5. Intended Use: | The Sysmex® XS is an automated hematology analyzer for <i>in vitro</i> diagnostic use in clinical laboratories. |
| 6. Substantial<br>equivalence-similarities<br>and differences | The following table compares the XS with the predicate method. |

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

| Comparison Table to Predicate Method | | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sysmex XE-2100<br>Predicate | Sysmex XS-Series<br>New Instrument |
| Intended Use | The SysmexTM XE-2100 is a multi-<br>parameter hematology analyzer<br>intended to classify formed elements<br>in anti-coagulated blood. The XE-<br>2100 can provide accurate and precise<br>test results for up to 32 analysis<br>parameters in whole blood. | The Sysmex® XS-Series is an<br>automated hematology analyzer for <i>in<br/>vitro</i> diagnostic use in clinical<br>laboratories. |
| Methodology | The XE-2100 performs hematology<br>analyses using the following methods:<br>RF/DC Detection Method, Sheath<br>Flow DC Detection Method, Flow<br>Cytometry Methods using a<br>Semiconductor Laser and SLS-<br>hemoglobin method. | The XS performs hematology<br>analyses using the following methods:<br>Sheath Flow DC Detection Method,<br>Flow Cytometry Methods using a<br>Semiconductor Laser and SLS-<br>hemoglobin method. |
| Type of<br>Anticoagulant | EDTA | EDTA |
| Specimen Type | Peripheral blood | Peripheral blood |
| Accuracy | Performance was established in the<br>previous 510(k) submission. | Comparison to the XE-2100 and XT-<br>Series analysers demonstrated<br>excellent correlation. |

#### Comparison Table to Predicate Method

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

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Nina M. Gamperling, MBA, MT (ASCP), RAC Manager, Regulatory Affairs Sysmex America, Inc. One Nelson C. White Parkway 1 1 0 2006 Mundelein, Illinois 60060

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: k060656

Trade/Device Name: Sysmex® XS, Automated Hematology Analyzer Regulation Number: 21 CFR & 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: March 10, 2006 Received: March 13, 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, PH.D 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

KOLOGGE 510(k) Number (if known):_

Device Name: Sysmex® XSTM, Automated Hematology Analyzer

Indications For Use:

The Sysmex® XS is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories.

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Concurrence of CHRD, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use _ fice of In Vitro Diagnostic Device valuation and Safe Sysmex America, Inc. 510(k) XS Submission