SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I

K021241 · Sysmex Corporation of America · GKZ · Jun 25, 2002 · Hematology

Device Facts

• Record ID: K021241
• Device Name: SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I
• Applicant: Sysmex Corporation of America
• Product Code: GKZ · Hematology
• Decision Date: Jun 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The Sysmex® XT-Series is intended for in vitro diagnostic use in the clinical laboratory as a multi-parameter hematology analyzer.

Device Story

The Sysmex XT-Series is an automated hematology analyzer used in clinical laboratories to analyze whole blood samples. The system comprises four units: a main unit for aspiration, dilution, mixing, and analysis; a sampler unit for automated sample supply; an Information Processing Unit (IPU) for data processing and operator interface; and a pneumatic unit for pressure and vacuum. The device utilizes flow cytometry with a semiconductor laser for WBC analysis, DC detection for RBC and PLT, and the SLS-Hgb method for hemoglobin measurement. The system provides automated hematological parameters including WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RET, and PLT indices. Operators (laboratory technicians) use the IPU to review results, which support clinical decision-making regarding patient hematological status.

Clinical Evidence

Equivalency studies were performed comparing the XT-Series to the XE-2100 predicate. Results indicated equivalent performance across all measured hematological parameters.

Technological Characteristics

Automated hematology analyzer; utilizes DC detection method for RBC/PLT, flow cytometry with semiconductor laser for WBC, and SLS-Hgb method for hemoglobin. System includes main unit, sampler, IPU, and pneumatic unit. Connectivity via IPU for data processing. Dimensions: 630x520x720 mm.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories as a multi-parameter hematology analyzer for 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 (K992875)

Reference Devices

• SF-3000 (K950508)

Submission Summary (Full Text)

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SYSMEX CORPORATION OF AMERICA 6699 Wildlife Way Long Grove IL 60047-9596 [phone] [phone] Facsimile

JUN 2 5 2002

## 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: KO312-41

| 1. Submitted by: | Sysmex Corporation of America<br>6699 Wildlife Way | | | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| | Long Grove, IL 60047-9596 | | | | |
| | Phone: [phone]; FAX: [phone] | | | | |
| | Contact person: Nina Gamperling | | | | |
| | Date prepared: April 18, 2002 | | | | |
| | | | | | |
| 2. Name of Device: | Trade or proprietary name: Sysmex® XT-Series | | | | |
| | Common name: Automated Hematology Analyzer | | | | |
| | Classification name: Automated Differential Cell Counter<br>21 CFR 864.5220 | | | | |
| 3. Predicate Device: | Sysmex® XE-2100 | | | | |
| 4. Device Description: | The XT-Series is an automated hematology analyzer which<br>consists of four principle units: (1) Main Unit which aspirates,<br>dilutes, mixes, and analyzes whole blood samples; (2) Sampler<br>Unit which supplies samples to the Main Unit automatically: (3)<br>IPU (Information Processing Unit) which processes data from the<br>Main Unit and provides the operator interface with the system:<br>(4) Pneumatic Unit which supplies pressure and vacuum from the<br>Main Unit. Additional information on the XT is presented in the<br>following table. | | | | |
| 5. Intended Use: | The Sysmex® XT-Series is intended for in vitro diagnostic use in<br>the clinical laboratory as a multi-parameter hematology analyzer. | | | | |
| 6. Substantial | The following table compares the XT-Series with the XE- | | | | |
| equivalence-similarities | 2100. | | | | |
| and differences | | | | | |
| 7. Clinical Performance | Studies were performed to evaluate the equivalency of the | | | | |
| Data: | XT-Series to the XE-2100. Results indicated equivalent | | | | |
| | performance. | | | | |
| 8. Conclusions: | The performance data demonstrated substantial equivalence. | | | | |
| | Page 9 | | | | |

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SYSMEX CORPORATION

of america 6699 Wildlife Way Long Grove IL 60047-9596 [phone] [phone] Facsımıle

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) Comparison Table to Predicate Device

| Features | XT-Series | XE-2100 | SF-3000 | |
|------------------|-------------------------------------|-------------------------------------|-------------------------|--|
| (Submission #) | | (K992875) | (K950508) | |
| FDA Clearance | | 3-Nov-99 | 3-Nov-95 | |
| Intended Use | Automated blood cell | Automated blood cell | Automated blood cell | |
| | analyzer | analyzer | analyzer | |
| Sample Type | Whole blood | Whole blood | Whole blood | |
| Sample Volume | 150uL- Cap piercer | 200 L- Cap piercer | 270uL- Cap piercer | |
| | 85 µL -Manual | 130uL -Manual | 170uL -Manual | |
| | 40 L-Capillary dilution | 40uL-Capillary dilution | 40uL-Capillary dilution | |
| Performance | Same | Proven performance in | Proven performance in | |
| | | FDA submission | FDA submission | |
| Parameters | WBC, Neut%/#, | WBC, Neut%/#, | WBC, Neut%/#. | |
| | Lymph%/ #, Mono%/#, | Lymph%/ #, Mono%/#, | Lymph%/#, Mono%/#, | |
| | Eos%/#, Baso%/#, | Eos%/#, Baso%/#, | Eos%/#, Baso%/#, | |
| | RBC, HGB, HCT, | NRBC%/#, RBC, HGB, | RBC, HGB, HCT, | |
| | MCV, MCH, MCHC, | HCT, MCV, MCH, | MCV, MCH, MCHC, | |
| | RDW-CV, RDW-SD, | MCHC, RDW-CV, | RDW-CV, RDW-SD, | |
| | RET%/#, IRF, HFR*, | RDW-SD, RET%/#, | PLT, PDW, MPV, P- | |
| | MFR*, LFR*, PLT, | IRF, HFR*, MFR*, | LCR. | |
| | MPV, PDW*, P-LCR*, | LFR*, PLT, MPV, | | |
| | PCT* | PDW*, P-LCR*, PCT* | | |
| | *Not reportable in USA | *Not reportable in USA | | |
| Reagents | Cellpack. | Cellpack, Cellsheath | Cellpack, Sulfolyzer, | |
| | Stromatolyser-FB, | Stromatolyser-FB, | StromatolyserFD(I), | |
| | Stromatolyser-4DL, | Stromatolyser-4DL, | StromatolyserFD(II). | |
| | Stromatolyser-4DS, | Stromatolyser-4DS, | Stromatolyser-FB | |
| | Sulfolyser, | Stromatolyser, NR, | | |
| | Ret-Search II | Stromatolyser-IM, | | |
| | | Sulfolyser, | | |
| | | Ret-Search II | | |
| Principles | RBC, PLT: DC | RBC, PLT: Sheath-flow | RBC, PLT: DC | |
| | detection method, | DC detection method, | detection method. | |
| | WBC: Flow Cytometry<br>method using | WBC: Flow Cytometry | WBC: Flow using | |
| | semiconductor laser | method using<br>semiconductor laser | semiconductor laser | |
| | detection method | detection method | | |
| | HGB: SLS-Hgb method | HGB: SLS-Hgb method | HGB: SLS-Hgb method | |
| Dimensions | 630x520x720 | 711x706x912 | 600x580x450 | |
| (HxWxD) (mm) | | | | |
| Weight (kg) | ਟ ਰੇ | ਹੇਤੇ | 60 | |
| QC System | L-J: 20 Files with 300 | L-J: 10 Files with 300 | L-J: 12 Files with 180 | |
| | points per file | points per file | points per file | |
| Bar Code | Yes | Yes | Yes | |
| No. of Test / Hr | Approx 80 | Approx 113-150 | Approximately 80 | |

- Page 10

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DEPARTMENT OF HEALTH & HUMAN SERVICES

# 'JUN 2 5 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nina M. Gamperling, MBA, MT (ASCP), RAC Manager, Regulatory Affairs Sysmex Corporation of America 6699 Wildlife Way Long Grove, Illinois 60047-9596

Re: k021241

> Trade/Device Name: Sysmex® XT-Series Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: June 17, 2002 Received: June 18, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".

Sincerely yours,

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: XT-Series, Automated Hematology Analyzer

Indications For Use:

The Sysmex® XT-Series is intended for in vitro diagnostic use in the clinical laboratory as a multi-parameter hematology analyzer.

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Concurrence of CHRD, Office of Device Evaluation (ODE)

| Prescription Use | <div>✓</div> | OR | Over-The-Counter Use | |
|------------------|--------------|----|----------------------|--|
|------------------|--------------|----|----------------------|--|


| (Division Sign-Off) |
|-------------------------------------------------|
| Division of Clinical Laboratory Devices K121241 |

510(k) Number ----------------------------------------------------------------------------------------------------------------------------------------------------------------

XT-Series, Automated Hematology Analyzer 510(k) FDA Submission