MS 9/5 HEMATOLOGY ANALYZER
Device Facts
| Record ID | K050436 |
|---|---|
| Device Name | MS 9/5 HEMATOLOGY ANALYZER |
| Applicant | Melet Schloesing Laboratories USA |
| Product Code | GKZ · Hematology |
| Decision Date | Jul 27, 2005 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 864.5220 |
| Device Class | Class 2 |
Indications for Use
The MS 9/5 is a quantitative, automated hematology analyzer that provides a leukocyte differential count for in-vitro diagnostic use in clinical laboratories.
Device Story
The MS 9/5 Hematology Analyzer is an automated system designed for clinical laboratory use. It processes blood samples to perform quantitative leukocyte differential counts. The device automates the counting process, providing results to healthcare professionals to assist in hematological assessment and clinical decision-making. By providing rapid, automated differential counts, the device aids in the diagnosis and monitoring of various hematological conditions.
Clinical Evidence
No clinical data provided in the document; substantial equivalence determination based on regulatory classification and intended use.
Technological Characteristics
Automated hematology analyzer; quantitative leukocyte differential counting; in-vitro diagnostic device; Class II; Product Code GKZ.
Indications for Use
Indicated for use in clinical laboratories as a quantitative, automated hematology analyzer to provide leukocyte differential counts from 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.”
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE
A. 510(k) Number:
K050436
B. Purpose for Submission:
New Device
C. Manufacturer and Instrument Name:
MS 9/5 Hematology Analyzer, Melet Schloesing Laboratories USA
D. Type of Test or Tests Performed:
Quantitative, White Blood Cells (WBC), Red Blood Cells (RBC), Platelets, Hemoglobin, White Blood Cell Differential, Hematocrit
E. System Descriptions:
1. Device Description:
The MS 9/5 is a quantitative, automated hematology analyzer that provides a leukocyte differential count for in-vitro diagnostic use in clinical laboratories. The analyzer utilizes the Coulter principle to enumerate white blood cells, red blood cells and platelets. The system consists of a single stand-alone analyzer unit and five reagents which are utilized during its measurement and cleaning cycle. The system also includes on-board software to record and report patients values as well as the ability to monitor the performance of standardized quality control materials.
2. Principles of Operation:
The MS 9/5 hematology analyzer utilizes the Coulter principle to enumerate white blood cells, red blood cells and platelets based on their impedance of an electrical field as the cell is aspirated through a calibrated orifice. Hemoglobin is determined by the ICSH recommendation standard Drabkin's method of measurement of reduced hemoglobin in a potometric chamber at 540nm. White blood cells types are differentiated by volume based on the lobulation of their nucleus into three different subpopulations: Lymphocytes, Monocytes and Granulocytes. The basophils and eosinophils are further differentiated based on their granulation.
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3. Modes of Operation:
The blood sampling system is a manual placement of single tube followed by automatic sampling and analysis for both open and closed tubes.
4. Specimen Identification:
The specimen identification number is generated automatically.
5. Specimen Sampling and Handling:
The MS 9/5 system requires whole blood anticoagulated with $\mathrm{K}_2\mathrm{EDTA}$ in plastic or glass tubes. Blood collection should be free of trauma. Blood tubes should be mixed by hand gently with the anticoagulant immediately after drawing the sample and mixed gently by hand or mechanical mixer immediately prior to analysis. Blood should be assayed within four hours if stored at room temperature and 24 hours if stored between 0 and $4^{\circ}\mathrm{C}$.
6. Calibration:
The MS 9/5 analyzer is calibrated at setup. Changing reagent does not require recalibration unless indicated by unacceptable quality control results according to the laboratory's procedures. Calibration verification must be performed in accordance with the laboratory's regulatory requirements. Calibration material is supplied by an independent vendor.
7. Quality Control:
A minimum of two levels of quality control material should be run a minimum of every day of testing and with each change of reagent lot. Quality control materials are obtained from an independent vendor.
8. Software:
The software for the MS 9/5 allows the user to: (1) Analyze a sample or a control, to display and print the results, (2) Recall an analysis from the memory and print it, (3) Modify the parameters of the banks (i.e. reference values), (4) Modify the system parameters (i.e. time, date, etc.), (5) Make the device perform maintenance actions (i.e. priming of reagent). The software can interface with an external keyboard, mouse, printer and computer.
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FDA has reviewed applicant's Hazard Analysis and Software Development processes for this line of product types:
Yes ☐ X or No ☐
## F. Regulatory Information:
1. Regulation section:
21 CFR 864.5220
2. Classification:
Class II
3. Product code:
GKZ
4. Panel:
(81) Hematology
## G. Intended Use:
1. Indication(s) for Use:
The MS 9/5 is a quantitative, automated hematology analyzer that provides a leukocyte differential count for in-vitro diagnostic use in clinical laboratories.
2. Special Conditions for Use Statement(s):
Not applicable.
## H. Substantial Equivalence Information:
1. Predicate Device Name(s) and 510(k) numbers:
Bayer Advia 120 Hematology System, K971998
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# 2. Comparison with Predicate Device:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | MS 9/5 | Bayer Advia 120 |
| WBC measurement principle | Red cells are hemolyzed by reagent and WBCs analyzed by laser light scatter signals. | Same |
| RBC measurement principle | Analyzed by a single optical cytometer after dilutions. | Same |
| Platelet measurement principle | Platelets counted with RBCs from a common detector with 2 different gain settings. | Same |
| Platelet measurement principle | Platelets counted with RBCs from a common detector with 2 different gain settings. | Same |
| RBC/ Platelet Size | Simultaneous measurement of laser light scatter | Same |
| Hemoglobin measurement | ICSH cyanmethemoglobin method | Same |
| Eosinophil and Basophil measurement | Cytochemical | Same |
| Red Cell indices (MCH, MCHC) | Mathematically calculated from RBC count, hemoglobin and MCV determination | Same |
| Determination of Hematocrit | Mathematically calculated from RBC count and MCV | Same |
| RDW and PDW | Calculated by cell-by-cell measurement of cell volume and hemoglobin concentration | Same |
| Patient abnormal flags | Set based on user requirements | Same |
| Quality Control Analysis and Data Storage | On-board software module | Same |
| Sample Type | Whole blood collected in EDTA | Same |
| Precision (except platelets) | All parameters less than 3% | Same |
| Probe Cleaning | Automated, Self-Cleaning | |
| Software Upgrade | Available on CD | Same |
| Power Supply | Completely contained within instrument | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | MS 9/5 | Bayer Advia 120 |
| Differentiation of Granulocytes, Monocytes and Lymphocytes | Nucleus to Plasma Density/Volume | Reaction to cytochemical staining and analysis |
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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Blood sampling system | Manual placement of single tube followed by automatic sampling and analysis for both open and closed tube. | Automatic sampling of closed tubs from multiple tube racks or single tube port. Manual open tube mode option available. |
| Sample Volume | 60 μL | 157μL |
| Throughput | 45 per hour | 120 per hour |
| Measurement of Reticulocytes and CHr | The MS 9/5 does not perform measurement of reticulocytes of CHr. | Performs reticulocytes measurements |
| Method of Calibration | Requires moderate amount of manual input | Requires minimal manual input |
| Calibrator and Quality Control Material | Available from Independent Distributor | Available from Bayer |
| Analytical Ranges (Linearity) | Limits of Linearity are less than the Advia 120 due to limitation of sample tested | Linearity ranges exceed those of the MS 9/5 |
| Platelet Precision | 5.3% | 2.93% |
| Sample Stability | 6 hours at room temperature and 24 hours at 4 °C | Depends on parameter. Stable from 8 to 72 hours at room temperature, and 8 to 72 hours refrigerated |
| Operator Manual | Printed Version | On-Line |
| Waste Disposal | Manual | Closed System through pneumatic option |
| Fluidics and mechanical system | Uses computer controlled, motor-driven peristaltic pumps and syringes for the fluidics and mechanical systems | Computer controlled pneumatically driven system for fluidics and mechanical systems |
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
J. Performance Characteristics:
1. Analytical Performance:
a. Accuracy:
120 whole blood samples were assayed in duplicate on the MS 9/5 and the predicate device using three reagent lots for each component on each instrument. The results are as follows:
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| Analyte | Slope | Intercept | r | r² |
| --- | --- | --- | --- | --- |
| WBC (10³/uL) | 1.017 | +0.28 | 0.99 | 0.98 |
| RBC (10⁶/uL) | 0.997 | +0.17 | 0.97 | 0.94 |
| Hemoglobin (g/dL) | 0.995 | -0.65 | 0.99 | 0.98 |
| Hematocrit (%) | 1.046 | -0.89 | 0.95 | 0.90 |
| Platelet (10³uL) | 0.995 | -0.32 | 0.95 | 0.90 |
White Blood Cell Differential Correlation: Manual differentials (300 cells) were performed and the cells were classified as positive or negative based on the criteria defined in the Reference Leukocyte Differential Count (Proportional) and Evaluation Methods, Approved Standard, NCCLS, H20-A. The false positive and false negative ratios of the MS 9/5 are shown below. Additionally, a t-test to detect systematic error and a f-test to detect random error were applied to compare the MS 9/5 data with the predicate device.
| Cell Type | Manual Differential | | Automated Differential | |
| --- | --- | --- | --- | --- |
| | False Positive Ratio (%) | False Negative Ratio (%) | t test at p=0.05 | f test at p=0.05 |
| Granulocytes | 2.1 | 1.4 | No systematic error | No random error |
| Lymphocytes | 2.2 | 2.3 | No systematic error | No random error |
| Monocytes | 1.9 | 1.2 | No systematic error | No random error |
| Basophils | 1.0 | 1.0 | No systematic error | No random error |
| Eosinophils | 2.8 | 2.9 | No systematic error | No random error |
| Morphology Classification | 1.5 | 1.9 | No systematic error | No random error |
## b. Precision/Reproducibility:
A single lot number of whole blood control material was pooled and divided into four portions, each sufficient for 5 day testing. Each portion was assayed in duplicate twice a day for 5 days, for a total of 20 test days. The results are as follows:
| | | Within-Run | | Between-Day | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Analyte | Mean | SD | CV | SD | CV | SD | CV |
| WBC (10³/uL) | 9.86 | 0.155 | 1.6 | 0.122 | 1.2 | 0.197 | 2.0 |
| RBC (10⁶/uL) | 4.26 | 0.083 | 1.9 | 0.044 | 1.0 | 0.094 | 2.2 |
| MCV (fL) | 83.81 | 0.83 | 1.0 | 0.64 | 0.8 | 1.50 | 1.8 |
| Hemoglobin (g/dL) | 12.9 | 0.19 | 1.5 | 0.12 | 0.9 | 0.24 | 1.9 |
| Platelets (%) | 229 | 9.8 | 4.3 | 5.1 | 2.2 | 12.1 | 5.3 |
| MPV (fL) | 8.4 | 0.15 | 1.8 | 0.07 | 0.9 | 0.22 | 2.7 |
| RDW (%) | 13.7 | 0.13 | 0.9 | 0.10 | 0.7 | 0.23 | 1.7 |
## c. Linearity:
Linearity was determined by assaying normal and abnormal specimens (in triplicate) for the parameters below. For each determination, duplicate assays were preformed for each of five dilutions within the stated range.
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| Linear Range | Low Limit Tested | High Limit Tested | Slope | r2 |
| --- | --- | --- | --- | --- |
| WBC (x103μL) | 1.6 | 54.0 | 1.01 | 0.98 |
| RBC (x106μL) | 0.82 | 7.91 | 0.97 | 0.98 |
| Hemoglobin (g/dL) | 2.3 | 24.5 | 0.99 | 0.99 |
| Platelets (x103μL) | 21 | 769 | 1.02 | 0.95 |
| Hematocrit (%) Used to determine MCV | 10 | 75 | 1.04 | 0.98 |
# d. Carryover:
A sample with a high concentration of the analyte was assayed three consecutive times, followed by the analysis of a low sample three consecutive times. The results are as follows:
| Parameter | High Sample Concentration | Low Sample Concentration | % Carryover |
| --- | --- | --- | --- |
| WBC | 49.1 | 2.1 | 0.9 |
| RBC | 7.35 | 1.32 | 1.2 |
| Hemoglobin | 18.9 | 5.9 | 1.3 |
| Platelets | 685 | 28 | 1.9 |
# e. Interfering Substances:
Samples with extreme lipemia, chylomicrons, or extremely high bilirubin concentrations might produce falsely elevated hemoglobin values. In-house studies show that accurate hemoglobin values are produced in samples with bilirubin values up to $20\mathrm{mg / dL}$ .
# 2. Other Supportive Instrument Performance Data Not Covered Above:
An in-house comparison study was performed on 100 samples, assayed within two hours of collection, using at least three reagent lots. The results are as follows:
| Analyte | Slope | Intercept | r | r2 |
| --- | --- | --- | --- | --- |
| WBC (103/uL) | 0.97 | +0.23 | 0.99 | 0.98 |
| RBC (106/uL) | 1.02 | -0.06 | 0.97 | 0.94 |
| Hemoglobin (g/dL) | 1.02 | -0.21 | 0.99 | 0.98 |
| Hematocrit (%) | 1.05 | -1.3 | 0.95 | 0.90 |
| Platelet (103uL) | 1.05 | -2.3 | 0.96 | 0.92 |
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Clinical Sensitivity and Specificity were assessed against the predicate device. See results below:
| Parameter | Sensitivity (%) | False Negative (%) | Specificity (%) | False Positive (%) |
| --- | --- | --- | --- | --- |
| WBC | 95.8 | 4.2 | 95.6 | 4.4 |
| RBC | 96.3 | 3.7 | 95.7 | 4.3 |
| Hemoglobin | 96.4 | 3.6 | 95.8 | 4.2 |
| MCV | 95.1 | 4.9 | 95.4 | 4.6 |
| Platelets | 95.8 | 4.2 | 95.4 | 4.6 |
| White Cell Differential | Refer to 1.(a) White Blood Cell Differential Correlation | | | |
| Cell Morphology | Refer to 1.(a) White Blood Cell Differential Correlation | | | |
# 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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