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

Indications for 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)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
K051459

B. Purpose for Submission:
Extension of Mean Cell Volume (MCV) parameter stability to 48 hours

C. Manufacturer and Instrument Name:
Sysmex America, Inc., Sysmex XE-2100DC Automated Hematology Analyzer

D. Type of Test or Tests Performed:
Quantitative, Mean Cell Volume (MCV)

E. System Descriptions:

1. Devise Description:
The Sysmex XE-2100DC is an automated hematology analyzer which can analyze 21 parameters in whole blood. These parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMP %/#, MONO %/#, EO%/#, and BASO %/#.

The XE-2100DC system consists of four principle units and three printers, which are: (1) Main unit, which analyzes and controls samples, (2) Sampler Unit, which supplies samples to the Main Unit automatically, (3) Information Processing Unit (IPU), which processes data which gets from the Main Unit, (4) Pneumatic Unit, which supplies pressure and vacuum used by the Main Unit, (5) Color Graphic Printer, which prints a hadcopy of analysis results for screen of histograms, scattergrams, etc, (6) Data Printer, which prints analysis data in the examination ticket format, and (7) Page Printer, which prints lists of analysis information or results. Operator interface with the IPU is accomplished with the use of a 22-key panel keyboard. The analyzer processes approximately 113 to 150 samples per hour, depending on the mode used.

2. Principles of Operation:
The XE-2100DC performs hematology analyses using the following methods: Sheath Flow DC Detection Method, Flow Cytometry Methods using a Semiconductor Laser and Sodium Lauryl Sulfate (SLS) hemoglobin Method.

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WBCs, are analyzed by the optical detector block based on the flow cytometry method using a semiconductor laser. RBCs and platelet count are analyzed by the RBC detector using the Hydro Dynamic Focusing (DC Detection) method. Hemoglobin(HBG) is analyzed by the HGB detector based on the SLS-hemoglobin detection method. Analysis data is displayed on the panel keypad LCD screen and IPU.

3. Modes of Operation:
Manual, Capillary, Sampler (Automatic), Manual Closed

4. Specimen Identification:
Specimen information is managed by four menu lists and specimen identification input is manual (by operator) or by barcode reader.

5. Specimen Sampling and Handling:
Whole blood tubes (corresponding to the amount of EDTA anticoagulant) are manually mixed by inversion before sampling.

6. Calibration:
The manufacturer's instructions are to be followed for materials and frequency of calibration. Following installation calibration, it is requested to verify instrument calibration every six months or on an "as needed" basis, and maintain good QC practices, to ensure the accuracy of the system.

7. Quality Control:
The manufacturer's instructions are to be followed for materials and frequency of quality control analysis.

8. Software:
The role of the software on the XE-2100DC analyzer is to operate the instrument in order to analyze whole blood samples and to provide a way to store and review data. One of the software programs allows the user to set user-definable flags according to their laboratory protocol. The XE IPU PIM (Patient Information Manager) software analyzes the data and works in conjunction with the Windows 2000 operating system, which serves as an administrative function.

FDA has reviewed applicant's Hazard Analysis and Software Development processes for this line of product types:

Yes ☐ X or No ☐

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F. Regulatory Information:

1. Regulation section:
21 CFR 864.5220, Automated Differential Cell Counter

2. Classification:
Class II

3. Product code:
GKZ, Counter, Differential Cell

4. Panel:
Hematology (81)

G. Intended Use:

1. Indication(s) for 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-2100 analyzes the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMP %/#, 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).

2. Special Conditions for Use Statement(s):
Not applicable.

H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:
Sysmex XE-2100, K992875

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2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Sysmex XE-2100DC | Sysmex XE-2100 |
| 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-2100 analyzes the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMP %/#, 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). | 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. |
| Methodology | Analyses using the following methods: Sheath Flow DC Detection Method, Flow Cytometry Methods using a Semiconductor Laser and SLS-hemoglobin method. | 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. |
| Type of Anticoagulant | EDTA | EDTA |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Diluting Reagent | CELLSHEATH (C) | CELLSHEATH |

I. Special Control/Guidance Document Referenced (if applicable):

Class II Special Control Guidance Document: Premarket Notification for Automated Differential Cell Counters for Immature or Abnormal Blood Cells Final Guidance for Industry and FDA, December 4, 2001

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 11, 2005

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy:

Accuracy was established by comparing RBC parameters, most specifically the MCV, on the XE-2100DC and the predicate analyzer. 138 samples with

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various abnormal conditions were used. The results are as follows:

MCV

| Correlation (r) | r2 | Regression |
| --- | --- | --- |
| 0.98 | 0.9565 | y=0.8849x + 6.0577 |

# b. Precision/Reproducibility:

A minimum of 5 blood samples were assayed 20 consecutive times. The results are as follows:

MCV With-in Run Precision using blood samples

| N=20 | Mean | SD | CV% |
| --- | --- | --- | --- |
| Sample #15 | 88.17 | 0.19 | 0.21 |
| Sample #14 | 85.40 | 0.18 | 0.22 |
| Sample # 13 | 75.88 | 0.19 | 0.26 |
| Sample # 12 | 78.88 | 0.19 | 0.24 |
| Sample #1 | 90.81 | 0.17 | 0.18 |
| Manuf. Specs. | | | ≤1.5% |

# c. Linearity:

Linearity was evaluated using a series of dilutions of residual patient material. Replicates of three were measured at each level. RBC linearity was generated using greater than 5 levels. The results are as follows:

RBC Linearity results

| Correlation (r) | r2 | Regression | Range (x106/μL) |
| --- | --- | --- | --- |
| 1.00 | 0.9986 | Y=0.0771x-0.0813 | 0.02-7.68 |

# d. Carryover:

Carryover was evaluated by assaying a sample with high RBC, HGB, HCT and PLT concentration three consecutive times followed immediately by testing a low sample three consecutive times. The test result showed zero carryover.

# e. Interfering Substances:

Not applicable.

# 2. Other Supportive Instrument Performance Data Not Covered Above:

# Stability:

28 samples (normal and abnormal) were used to determine stability to 48 hours. Each sample collected was split into 2 aliquots, one held at room temperature $(18^{\circ} - 26^{\circ}\mathrm{C})$ and the other held at low temperature $(4^{\circ}\mathrm{C})$ . Each sample was analyzed on the XE-2100DC and the designated Reference instrument at baseline (immediately or within 4 hours after blood collection), 24, 48 and 72 hours post collection. MCV results were expressed as percent deviation from the baseline measurement.

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The XE-2100DC analyzer result for MCV at 48 hours for both 4°C and room temperature samples exhibited ≤8% deviation.

## K. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

## L. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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