SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER

K992875 · Sysmex Corp. · GKZ · Nov 9, 1999 · Hematology

Device Facts

• Record ID: K992875
• Device Name: SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
• Applicant: Sysmex Corp.
• Product Code: GKZ · Hematology
• Decision Date: Nov 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The Sysmex™ XE-2100 is a multi-parameter hematology analyzer intended to classify the following formed elements in EDTA anti-coagulated blood: WBC (White Blood Cells or leukocyte count), Neut% (Neutrophil percent), Neut# (Neutrophil absolute count), Lymph% (Lymphocyte percent), Lymph# (Lymphocyte absolute count), Mono% (Monocyte percent), Mono# (Monocyte absolute count), Eo% (Eosinophil percent), Eo# (Eosinophil absolute count), Baso% (Basophil percent), Baso# (Basophil absolute count), NRBC% (Nucleated red blood cell percent), NRBC# (Nucleated red blood cell absolute count), RBC (Red Blood Cell or erythrocyte count), HGB (Hemoglobin concentration), HCT (Hematocrit), MCV (Mean Corpuscular Volume), MCH (Mean Cell Hemoglobin), MCHC (Mean Cell Hemoglobin Concentration), RDW-CV (Red Cell Distribution Width-Coefficient of Variation), RDW-SD (Red Cell Distribution Width-Standard Deviation), RET% (Reticulocyte percent), RET# (Reticulocyte absolute count), IRF (Immature Reticulocyte Fraction), HFR* (High Fluorescent Ratio), MFR* (Medium Fluorescent Ratio), LFR* (Low Fluorescent Ratio), PLT (Platelet count), MPV (Mean Platelet Volume), PDW* (Platelet Distribution Width), P-LCR* (Platelet- Large Cell Ratio), PCT* (Plateletcrit). *Not reportable in the USA

Device Story

Automated hematology analyzer for clinical laboratory use; processes whole blood samples to provide multi-parameter cell counts and differentials. System comprises four units: Main Unit (aspiration, dilution, mixing, analysis), Sampler Unit (automated sample supply), IPU (data processing/operator interface), and Pneumatic Unit (pressure/vacuum). Analyzes RBC/PLT via sheath-flow DC detection; WBC via flow cytometry using semiconductor laser detection. Output provided to clinicians for hematological assessment; aids in diagnosis and monitoring of pathological conditions. Benefits include high-throughput automated analysis compared to manual methods.

Clinical Evidence

Bench testing included carryover, precision, linearity, and sample stability studies. Clinical correlation studies compared XE-2100 results to manual differentials (per NCCLS H20A) and flow cytometry using specimens from healthy individuals and patients with various pathological conditions. Results demonstrated performance equivalent to predicate devices.

Technological Characteristics

Automated hematology analyzer; dimensions 711x706x912 mm; weight 93 kg. Sensing: Sheath-flow DC detection (RBC/PLT) and semiconductor laser flow cytometry (WBC). Connectivity: Barcode reader enabled. QC system: L-J 10 files/300 points. Throughput: 112-150 tests/hr.

Indications for Use

Indicated for the classification of formed elements in EDTA anti-coagulated blood for patients requiring hematological analysis.

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

• SE/RAM-1 (K964375)
• SF-3000 (K950508)

Submission Summary (Full Text)

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K992875

NOV - 9 1999

.

#### 510(k) Summary of Safety and Effectiveness Information SYSMEX™ Automated Hematology Analyzer XE-2100 August 25, 1999

Sysmex Corporation of America Gilmer Road, 6699 RFD Long Grove, IL 60047-9596

Contact Person: Nina Gamperling at 847-726-3675 or by facsimile at 847-726-3559

Trade or Proprietary Name: Sysmex™ XE-2100

Automated Hematology Analyzer Common or Usual Name:

Automated Differential Cell Counter 21 CFR 864.5220 Classification Name:

Intended Use: The Sysmex™ XE-2100 is a multi-parameter hematology analyzer intended to classify the following formed elements in anti-coagulated blood:

| WBC | White Blood Cells count | RBC | Red Blood Cell or erythrocyte count |
|--------|--------------------------------------------|--------|----------------------------------------------------------|
| Neut% | Neutrophil percent | HGB | Hemoglobin concentration |
| Neut# | Neutrophil absolute count | HCT | Hematocrit |
| Lymph% | Lymphocyte percent | MCV | Mean Corpuscular Volume |
| Lymph# | Lymphocyte absolute count | MCH | Mean Cell Hemoglobin |
| Mono% | Monocyte percent | MCHC | Mean Cell Hemoglobin Concentration |
| Mono# | Monocyte absolute count | RDW-CV | Red Cell Distribution Width-<br>Coefficient of Variation |
| Eo% | Eosinophil percent | RDW-SD | Red Cell Distribution Width-<br>Standard Deviation |
| Eo# | Eosinophil absolute count | RET% | Reticulocyte percent |
| Baso% | Basophil percent | RET# | Reticulocyte absolute count |
| Baso# | Basophil absolute count | IRF | Immature Reticulocyte Fraction |
| NRBC% | Nucleated red blood cell<br>percent | HFR* | High Fluorescence Ratio |
| NRBC# | Nucleated red blood cell<br>absolute count | MFR* | Medium Fluorescence Ratio |
| PLT | Platelet count | LFR* | Low Fluorescence Ratio |
| MPV | Mean Platelet Volume | | |
| PDW* | Platelet Distribution Width | | |
| P-LCR* | Platelet-Large Cell Ratio | | |
| PCT* | Plateletcrit | | |

*Not Reportable in USA

Device Description: The XE-2100 is an automated hematology analyzer which consists of four principal units: (1) Main Unit which aspirates, dilutes, mixes, and analyzes whole blood samples; (2) Sampler Unit which supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system; (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit. Additional information on the XE-2100 is presented in Table 1.

510(k) Premarket Notification Sysmex™ Automated Hematology Analzyer XE-2100

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Similarities and Differences to Predicate Devices: The Sysmex™ XE-2100 is substantially equivalent in intended use and technological characteristics to previous Sysmex™ instrumentation, the manual differential, and flow cytometry. A summary of the comparative features is presented in Table 1.

Supportive Data: Carryover, precision, linearity, and sample stability data show performance to manufacturer specifications. As demonstrated by correlation studies, the performance claims of the proposed device are similar to the predicate devices, the SE/RAM-1 and SF-3000. During these studies, specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for particular parameters. In addition, the WBC differential of the XE-2100 was correlated to results from manual differentials performed according to NCCLS H20A and to flow cytometry. The data from these studies supports our claim that the XE-2100 is substantially equivalent to predicate methods.

Conclusion: The Sysmex™ XE-2100 is substantially equivalent to the predicate methods, the SE/RAM-1 and SF-3000.

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| Features<br>(Submission #) | XE-2100 | SE/RAM-1<br>(K964375) | SF-3000<br>(K950508) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Clearance | --- | 13-Mar-97 | 3-Nov-95 |
| Intended Use | Automated blood cell<br>analyzer | Automated blood cell<br>counter | Automated blood cell<br>analyzer |
| Sample Type | Whole blood | Whole blood | Whole blood |
| Sample Volume | 200µL- Cap piercer<br>130µL -Manual<br>40µL-Capillary dilution | 250µL- Cap piercer<br>100µL -Manual<br>40µL-Capillary dilution | 270µL- Cap piercer<br>170µL -Manual<br>40µL-Capillary dilution |
| Performance | Same | Proven performance in<br>FDA submission | Proven performance in<br>FDA submission |
| Parameters | WBC, Neut%/#,<br>Lymph%/ #, Mono%/#,<br>Eos%/#, Baso%/#,<br>NRBC%/#, RBC, HGB,<br>HCT, MCV, MCH,<br>MCHC, RDW-CV,<br>RDW-SD, RET%/#,<br>IRF, HFR*, MFR*,<br>LFR*, PLT, MPV,<br>PDW*, P-LCR*, PCT*<br>*Not reportable in USA | WBC, Neut%/#,<br>Lymph%/ #, Mono%/#,<br>Eos%/#, Baso%/#,<br>RBC, HGB, HCT, MCV,<br>MCH, MCHC, RDW-<br>CV, RDW-SD, RET%/#,<br>IRF, PLT, MPV. | WBC, Neut%/#,<br>Lymph%/#, Mono%/#,<br>Eos%/#, Baso%/#,<br>RBC, HGB, HCT, MCV,<br>MCH, MCHC, RDW-<br>CV, RDW-SD, PLT,<br>PDW, MPV, P-LCR. |
| Reagents | Cellpack, Cellsheath<br>Stromatolyser-FB,<br>Stromatolyser-4DL,<br>Stromatolyser-4DS,<br>Stromatolyser, NR,<br>Stromatolyser-IM,<br>Sulfolyser,<br>Ret-Search II | Cellpack, Cellsheath,<br>Cellpack-3D,<br>StromatolyserWL(II),<br>Stromatolyser-3D,<br>StromatolyserEO(II),<br>Stromalyser-BA,<br>Stromatolyser-IM,<br>Sulfolyser, Ret-Search,<br>Ret-Sheath | Cellpack, Sulfolyzer,<br>Stromatolyser FD(I),<br>Stromatolyser FD(II),<br>Stromatolyser-FB |
| Principles | RBC, PLT: Sheath-flow<br>DC detection method,<br>WBC: Flow Cytometry<br>method using<br>semiconductor laser<br>detection method | RBC, PLT: Sheath-flow<br>DC detection method,<br>WBC: DC Detection<br>Method, RF/DC<br>Detection Method | RBC, PLT: DC<br>detection method,<br>WBC: Flow using<br>semiconductor laser |
| Dimensions<br>(HxWxD) (mm) | 711x706x912 | 720x636x820 | 600x580x450 |
| Weight (kg) | 93 | 80 | 60 |
| QC System | L-J: 10 Files with 300<br>points per file | L-J: 27 Files with 180<br>points per file | L-J: 12 Files with 180<br>points per file |
| Bar Code | Yes | Yes | Yes |
| No. of Test / Hr | Approx. 112-150 | Approximately 120 | Approximately 80 |

Table 1: Comparative Features to SE/RAM-1 and SF-3000

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

# NOV - 9 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nina Gamperling Supervisor, Clinical and Regualtory Affairs Sysmex Corporation of America Gilmer Road, 6699 RFD Long Grove, Illinois 60047-9596

Re: K992875

Trade Name: Sysmex™ Automated Hematology Analyzer XE-2100 Regulatory Class: II Product Code: GKZ Dated: August 25, 1999 Received: August 26, 1999

### Dear Ms. Gamperling:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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510(k) Number (if known): _ K 99 3825

Device Name: Sysmex ™ Automated Hematology Analyzer XE-2100

#### Indications For Use:

The Sysmex™ XE-2100 is a multi-parameter hematology analyzer intended to classify the following formed elements in EDTA anti-coagulated blood.

| WBC | White Blood Cells or leukocyte count |
|--------|------------------------------------------------------|
| Neut% | Neutrophil percent |
| Neut# | Neutrophil absolute count |
| Lymph% | Lymphocyte percent |
| Lymph# | Lymphocyte absolute count |
| Mono% | Monocyte percent |
| Mono# | Monocyte absolute count |
| Eo% | Eosinophil percent |
| Eo# | Eosinophil absolute count |
| Baso% | Basophil percent |
| Baso# | Basophil absolute count |
| NRBC% | Nucleated red blood cell percent |
| NRBC# | Nucleated red blood cell absolute count |
| RBC | Red Blood Cell or erythrocyte count |
| HGB | Hemoglobin concentration |
| HCT | Hematocrit |
| MCV | Mean Corpuscular Volume |
| MCH | Mean Cell Hemoglobin |
| MCHC | Mean Cell Hemoglobin Concentration |
| RDW-CV | Red Cell Distribution Width-Coefficient of Variation |
| RDW-SD | Red Cell Distribution Width-Standard Deviation |
| RET% | Reticulocyte percent |
| RET# | Reticulocyte absolute count |
| IRF | Immature Reticulocyte Fraction |
| HFR* | High Fluorescent Ratio |
| MFR* | Medium Fluorescent Ratio |
| LFR* | Low Fluorescent Ratio |
| PLT | Platelet count |
| MPV | Mean Platelet Volume |
| PDW* | Platelet Distribution Width |
| P-LCR* | Platelet- Large Cell Ratio |
| PCT* | Plateletcrit |
| | *Not reportable in the USA |

Peter G. Maden

Laboratory Dev

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Concurrenet of CHRD, Office of Device Evaluation (ODE) ﮯ Presription Use __ Over-The-Counter Use OR (Optional Format 1-2-96) (Per 21 CFR 801.109)

510(k) Premarket Notification Sysmex™ Automated Hematology Analzyer XE-2100

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