SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER

K051459 · Sysmex America, Inc. · GKZ · Sep 23, 2005 · Hematology

Device Facts

• Record ID: K051459
• Device Name: SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER
• Applicant: Sysmex America, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Sep 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The Sysmex XE-2100DC is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories and reference laboratories. The XE-2100DC analyzes the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV and NEUT %/#, LYMPH %/#, MONO %/#, EO %/#, and BASO %/#. The XE-2100DC will extend the stability of the MCV parameter in EDTA anticoagulated whole blood samples to 48 hours at 4°C and room temperatures (18-26°C).

Device Story

Sysmex XE-2100DC is an automated hematology analyzer for clinical/reference laboratories. It processes whole blood samples (EDTA anticoagulant) via manual or automatic sampler units. Input samples undergo analysis using Sheath Flow DC detection, semiconductor laser flow cytometry, and SLS-hemoglobin methods. The system includes a main unit, sampler, information processing unit (IPU), and pneumatic unit. The IPU processes data, manages patient information, and allows user-definable flagging. Output includes quantitative results for 21 parameters (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, and differential counts) displayed on an LCD screen and printed via connected printers. The device provides stable MCV parameter results for up to 48 hours post-collection at 4°C or room temperature. Healthcare providers use these results for hematological screening and clinical decision-making.

Clinical Evidence

Bench testing only. Studies evaluated the equivalency of the XE-2100DC to the predicate XE-2100. Results confirmed that the XE-2100DC successfully extends the stability of the MCV parameter in EDTA anticoagulated whole blood samples to 48 hours at 4°C and room temperature (18-26°C).

Technological Characteristics

Automated hematology analyzer. Methods: Sheath flow DC detection, semiconductor laser flow cytometry, SLS-hemoglobin. Hardware modifications: tubing, heating block. Software: Proprietary temperature algorithms. Specimen: EDTA anticoagulated peripheral blood.

Indications for Use

Indicated for in vitro diagnostic screening of patient populations in clinical and reference laboratories using EDTA anticoagulated 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 XE-2100, Automated Hematology Analyzer

Submission Summary (Full Text)

{0}------------------------------------------------

## 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: _K051459_

| <b>1. Submitted by:</b> | 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: September 2, 2005 |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>2. Name of Device:</b> | Trade or proprietary name: Sysmex® XE-2100DC, Automated Hematology Analyzer.<br><br>Common name: XE-2100DC<br><br>Classification name: Automated Differential Cell Counter,<br>Sysmex® XE-2100DC (21 CFR 864.5220) |
| <b>3. Predicate Device:</b> | The Sysmex® XE-2100DC, Automated Hematology Analyzer, is<br>substantially equivalent to the Sysmex XE-2100, Automated<br>Hematology Analyzer. |
| <b>4. Device Description:</b> | The XE-2100 is an automated hematology analyzer previously<br>cleared by the FDA. XE-2100DC will extend MCV stability to<br>48 hours. (Note: XE pro software is required to obtain results<br>described.) |
| <b>5. Intended Use:</b> | The Sysmex XE-2100DC is an automated hematology analyzer<br>for <i>in vitro</i> diagnostic use in screening patient populations found<br>in clinical laboratories and reference laboratories. The XE-<br>2100DC analyzes the following parameters: WBC, RBC, HGB,<br>HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV<br>and NEUT %/#, LYMPH %/#, MONO %/#, EO %/#, and BASO<br>%/#. The XE-2100DC will extend the stability of the MCV<br>parameter in EDTA anticoagulated whole blood samples to 48<br>hours at 4°C and room temperatures (18-26°C). |
| <b>6. Substantial<br/>equivalence-similarities<br/>and differences</b> | The following table compares the XE-2100DC with the predicate<br>method. |

{1}------------------------------------------------

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

.

| | | Sysmex XE-2100DC |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sysmex XE-2100 | | Modification of Predicate |
| | Predicate | |
| Intended Use | The Sysmex™ XE-2100 is a multi-parameter hematology analyzer intended to classify formed elements in anti-coagulated blood. The XE-2100 can provide accurate and precise test results for up to 32 analysis parameters in whole blood. | The Sysmex XE-2100DC is an automated hematology analyzer for <i>in vitro</i> diagnostic use in screening patient populations found in clinical laboratories and reference laboratories. The XE-2100DC analyzes the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV and NEUT %/#, LYMPH %/#, MONO %/#, EO %/#, and BASO %/#. The XE-2100DC will extend the stability of the MCV parameter in EDTA anticoagulated whole blood samples to 48 hours at 4°C and room temperature (18-26°C). |
| Methodology | The XE-2100 performs hematology analyses using the following methods: RF/DC Detection Method, Sheath Flow DC Detection Method, Flow Cytometry Methods using a Semiconductor Laser and SLS-hemoglobin method. | The XE-2100DC performs hematology analyses using the following methods: Sheath Flow DC Detection Method, Flow Cytometry Methods using a Semiconductor Laser and SLS-hemoglobin method. |
| Diluting<br>Reagent<br>Differences | CELLSHEATH | CELLSHEATH(C) |
| Software/<br>Hardware<br>Differences | --- | Hardware: Tubing changes; Heating block modification.<br>Software: Proprietary temperature algorithms |
| Type of<br>Anticoagulant | EDTA | EDTA |
| Specimen Type | Peripheral blood | Peripheral blood |
| Accuracy | Performance was established in the previous 510(k) submission. | Comparison to the XE-2100 demonstrated excellent correlation. |

#### Comparison Table to Predicate Method

| 7. Clinical Performance Data: | Studies were performed to evaluate the equivalency of XE-2100DC to the predicate method. Results indicated that the XE-2100DC will extend the stability of the MCV parameter in EDTA anticoagulated whole blood samples to 48 hours at 4°C and room temperature (18-26°C). |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 8. Conclusions: | The performance data demonstrated substantial equivalence. |

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

### SEP 2 3 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k051459

KU51439
Trade/Device Name: Sysmex® XE-2100DC™, Automated Hematology Analyzer Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: August 22, 2005 Received: August 26, 2005

Dear Ms. Gamperling:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 9 ro(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manent date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the enaoutines of the Federal Food, Drug, devices that have been reclassified in accordance was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appl and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, inelefone, market the devices, basics to the most registration, listing of
general controls provisions of the Act include requirements for annual registerading and general controls provisions of the free merals requirement of the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations DD may be subject to such additional connector initial (CFR), Parts 800 to 895. In addition, FDA
be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 899 Barri be found in This 21, Oods of I cases.
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 Please be advised mat IDA's issuated of a substition complies with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decemmanon that your are your assess. You must as a many as a ligit or any rederal statutes and regulations annuding, but not limited to: registration and listing (21 comply with an the Ace 3 requirements, morals 809); and good manufacturing practice CFK Part 807), labeling (21 CF N Fatts 607 and 603), egulation (21 CFR Part 820). This letters requirements as set form in the quality Systems (QS) in your Section 510(k) prematket will allow you to begin marketing your active quivalence of your device to a legally marketed notification. The I Dri inding of succion for your device and thus, permits your device to proceed to the market.

{3}------------------------------------------------

Page 2 --

If you desire specific information about the application of labeling requirements to your device, If you desire specific information and advertising of your device, please contact the Office of In of questions on the promostic Device Evaluation and Safety at [phone]. Also, please note the Vitro Diagnostic D'iMisbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may obain only general 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,

lobatz Beckerh

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

Enclosure

{4}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): __K051459

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

#### Indications For Use:

The Sysmex XE-2100DC is an automated hematology analyzer for in viro diagnostic use in screening patient populations found in clinical laboratories and reference laboratories. The XEscreening patient populations found in emmediations and CHARC, MCT, MCV, MCHC,
2100DC analyzes the following parameters: WBC, RBC, HCT, MCV, MCHC, MCHC, MCHC, MCHC, MCHC, MCH 2100DC allary25s the lonowing parameters: 1724, LYMPH %/#, MONO %/#, EO %/#, and
RDW-CV, RDW-SD, PLT, MPV and NEUT %/#, LYMPH %/#, MONO %/#, EDTA RDW-CV, KDW-SD, FLT, MF V and NEOT 76.hild NEV parameter in EDTA
BASO %/#. The XE-2100DC will extend the stability of the MCV parameter in EDTA BASO %4. The XE-2100DC will extend the stabling of and room temperatures (18-26℃).

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

Concurrence of CHRD, Office of Device Evaluation (ODE)

Prescription Use

X

Division Sign-Off

Over-The-Counter Use

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) K051459