SYSMEX POCH-100I

K032677 · Sysmex America, Inc. · GKL · Feb 11, 2004 · Hematology

Device Facts

• Record ID: K032677
• Device Name: SYSMEX POCH-100I
• Applicant: Sysmex America, Inc.
• Product Code: GKL · Hematology
• Decision Date: Feb 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Indications for Use

The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in a CLIA non-waived clinical laboratory (not for Point of Care use in a CLIA waived laboratory).

Device Story

Compact automated hematology analyzer for clinical laboratory use; processes whole blood or pre-diluted samples. Uses DC detection and hydrodynamic focusing (electric impedance) to count particles; employs non-cyanide method for hemoglobin measurement. Sample aspirated, diluted, and lysed in mixing chamber; lysed sample passes through single transducer for cell volume/number determination. Microprocessor calculates remaining parameters from measured values. Output provided to laboratory personnel for hematological assessment. Benefits include automated, quantitative blood cell analysis to support clinical decision-making regarding patient health status.

Clinical Evidence

Correlation studies performed comparing pocH-100i to predicate KX-21. Results demonstrated equivalent performance between the two analyzers.

Technological Characteristics

Compact automated hematology analyzer; DC detection and hydrodynamic focusing; non-cyanide hemoglobin measurement. Single transducer architecture. Reagents: pocH-pack D (diluent), pocH-pack L (lyse). Microprocessor-based calculation of hematology parameters.

Indications for Use

Indicated for in vitro diagnostic use in CLIA non-waived clinical laboratories for automated cell counting and hematological analysis. Not for point-of-care use in CLIA-waived laboratories.

Regulatory Classification

Identification

An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.

Predicate Devices

• Sysmex KX-21™ Automated Hematology Analyzer (K981761)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number: #K032677
B. Analyte(s): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM (#/%), NEUT (#/%), MXD (#/%), MPV, and RDW (SD/CV)
C. Type of Test: Quantitative
D. Applicant: Sysmex America, Inc.
E. Proprietary and Established Names: Sysmex pocH-100i Automated Hematology Analyzer

F. Regulatory Information:
1. Regulation section(s): 864.5200 – Automated Cell Counter (Particle Counter); 864.5220 – Automated Differential Cell Counter
2. Classification: II
3. Product Code(s): GKL; GKZ
4. Panel: Hematology (81)

G. Intended Use:
5. Intended use(s):
The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in a CLIA non-waived clinical laboratory (not for Point of Care use in a CLIA waived laboratory).
6. Indication(s) for use: Same
7. Special condition for use statement(s): N/A
8. Special instrument Requirements: N/A

H. Device Description:
The Sysmex pocH-100i Automated Hematology Analyzer is a compact instrument that provides analysis of (17) hematology parameters in whole blood mode, and the (8) bolded parameters as listed under B. Analytes, in pre-diluted mode.

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# I. Substantial Equivalence Information:

1. Predicate device name: Sysmex KX-21™ Automated Hematology Analyzer
2. Predicate K number(s): #K981761
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| For use in the clinical laboratory | Sysmex pocH-100i Automated Hematology Analyzer | Sysmex KX-21™ Automated Hematology Analyzer |
| Detection technology | DC detection | Same |
| Hematology parameters | (17) parameters | Same |
| Reagents | Diluent, lyse solution, 3-level quality control | Same |
| Analysis modes | Whole blood and pre-dilute | Same |
| Type of unit | Compact | Same |
| Differences | | |
| Item | Device | Predicate |
| Diluent and lyse reagent names | pocH-pack D; pocH-pack L | Cellpack; Stromatolyser - WH |
| Transducer(s) | Single | Dual |

# J. Standard/Guidance Document Referenced (if applicable):

1. NCCLS C28-A2:
How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline, 1995
2. Guidelines for the evaluation of blood cell
Analyzers including those used for differential leucocyte and reticulocyte counting and cell marker applications; ICSH 16:173, 1994
3. FDA Guidance
Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells, 2000.

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# K. Test Principle

The Sysmex pocH-100i Analyzer has a single transducer and utilizes DC detection, along with hydrodynamic focusing, for electric impedance particle counting. It employs a noncyanide hemoglobin method that uses diluent and lysing solutions. The sample is aspirated, measured and delivered into a mixing chamber where it is diluted. The lysing reagent is then added to dissolve red cells and release the hemoglobin. The lysed sample is transferred to the transducer, where the volume and number of blood cells are determined by the DC detection method. The remaining parameters are then calculated, based upon the measured values, by a microprocessor.

# L. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Within-run precision studies were performed on duplicates of normal blood samples (N= 10). The %CV's ranged 0.2 – 12.5%.

Between-day precision was done on (3) levels of quality control (QC) over a 24-day period. The %CV's ranged 0.4 – 17.4%.

All results met company specifications.

b. Linearity/assay reportable range:

Serial dilutions of patient blood were tested, with expected values plotted against obtained results. Both low and high values were calculated for the (5) measured parameters: WBC, RBC, HGB, HCT, and PLT.

The R2 values ranged 0.9935 – 0.9998, which met company specifications.

c. Traceability (controls, calibrators, or method):

Testing was based upon methods traceable to the ICSH cyanmethemoglobin method; NCCLS H15-A2: Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood, 2nd Edition, Approved Standard (1994); and H7-A2: Procedure for Determining Packed Cell Volume by the Microhematocrit Method, 2nd Edition, Approved Standard (1993).

d. Detection limit: N/A

e. Analytical specificity: N/A

f. Assay cut-off: N/A

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2. Comparison studies:
a. Method comparison with predicate device:
All (17) parameters were analyzed on the Sysmex pocH-100i and the Sysmex KX-21™ Automated Hematology Analyzers, using whole blood and pre-diluted samples (N=193). Linear regression equations were all within acceptable analytical limits, with “R” values ranging 0.90 – 1.00 for whole blood (except for a value, R=0.75, due to the small number of cells/types counted for one of the calculated parameters). R2 values for pre-diluted samples ranged 0.9368 – 0.9980.
b. Matrix comparison: N/A

3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A
c. Other clinical supportive data (when a and b are not applicable):
Performance data for carryover, linearity and method comparison were generated using clinical blood samples from patients with a variety of medical conditions.

4. Clinical cut-off: N/A

5. Expected values/Reference range:
Reference ranges were established for each parameter, using as a guide, NCCLS C28-A2: How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline, 1995. The company used normal donors (N=129). Females (N=67), ranged 20-79 years of age; and males (N=62), ranged 18-83 years of age. The mean age was 47 years.

M. Conclusion
All data from performance studies met the established acceptance criteria for this type of device. The Sysmex pocH-100i Automated Hematology Analyzer is substantially equivalent to the Sysmex KX-21™ Automated Hematology Analyzer, a legally marketed device.