BC-3200 AUTO HEMATOLOGY ANALYZER

K063407 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · GKZ · Jun 11, 2007 · Hematology

Device Facts

• Record ID: K063407
• Device Name: BC-3200 AUTO HEMATOLOGY ANALYZER
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: GKZ · Hematology
• Decision Date: Jun 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

The BC-3200 auto hematology analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter to be used in clinical laboratories for In Vitro Diagnostic purpose. The intended use of BC-3200 Auto Hematology Analyzer is to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies.

Device Story

The BC-3200 Auto Hematology Analyzer is an automated, quantitative hematology analyzer and leukocyte differential counter for clinical laboratory use. It processes human whole blood samples using two primary measurement methods: the Coulter method for WBC, RBC, and PLT counts, and a colorimetric method for HGB concentration. The system utilizes an automatic sampling, diluting, and mixing device. It outputs 16 hematological parameters and three histograms. The device flags results that fall outside of user-defined normal ranges, alerting clinicians to the need for further diagnostic investigation. It is operated by trained medical professionals. The system includes the analyzer, specific reagents, controls, and calibrators. By automating the counting and flagging process, the device assists in the efficient screening of patient blood samples, helping to identify those requiring manual review or additional testing.

Clinical Evidence

Clinical validation included a study of 200 samples comparing BC-3200 results to manual differential counts to assess flagging performance (82.5% agreement, 10.6% FPR, 45% FNR). Reproducibility was assessed via replicate testing (n=11) across low, normal, and high concentrations, showing CVs generally <5%. Linearity was verified using diluted samples across the analytical range. Inter-laboratory precision was evaluated using two sites. A normal range study was conducted on 121 donors to establish reference intervals. Correlation studies against the predicate device (n=103) showed high correlation coefficients (e.g., WBC r=0.9994, RBC r=0.9971).

Technological Characteristics

Automated hematology analyzer; impedance sensing for cell counting/sizing; colorimetric sensing for HGB. Dimensions/form factor: benchtop. Connectivity: barcode/manual keyboard entry. Software: moderate level of concern. Calibration: manual and auto-calibration programs. QC: L-J and X-B analysis programs. Sterilization: N/A (in vitro diagnostic instrument).

Indications for Use

Indicated for use in clinical laboratories by trained medical professionals to perform quantitative automated hematology analysis and leukocyte differential counting on human blood samples to identify normal patients and flag results requiring further investigation.

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

• COULTER® ACT diff 2™ Analyzer (K0990352)

Submission Summary (Full Text)

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

A. 510(k) Number:
K063407

B. Purpose for Submission:
This is an original-traditional 510(k) for a 16 parameter automated hematology analyzer and leukocyte differential cell counter with reagents, calibrator, and controls.

C. Manufacturer and Instrument Name:
Shenzhen Mindray Bio-Medical Electronics Co. LTD, BC-3200 Auto Hematology Analyzer

D. Type of Test or Tests Performed:
WBC, Lymph #, Mid#, Gran#, Lymph%, Mid%, Gran%, RBC, HGB, MCV, MCH, MCHC, RDW, HCT, MPV, and WBC Histogram, RBC Histogram, and PLT Histogram

E. System Descriptions:

1. Device Description:
The BC-3200 Auto Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic use in clinical laboratories. It is only to be used by trained medical professionals to identify the normal patient, with all normal system-generated parameters, and toflag or identify patient results that require additional studies. The analyzer provides analysis results of 16 parameter of human blood and three histograms.

2. Principles of Operation:
WBCs are counted and sized by the impedance method. This method is based on the measurement of changes in electrical resistance produced by a particle, which in this case is a blood cell suspended in a conductive diluent as it passes through an aperture of known dimensions. HGB is determined by the colorimetric method. RBCs and PLTs are counted by the impedance method also. In addition, for RBCs and Plts, volumetric metering is used. An accurate cell count cannot be obtained unless the precise volume of diluted sample that passes through the aperture during the count cycle is known. The analyzer uses a volumetric metering unit to

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control the count cycle and to ensure that a precise volume of sample is analyzed for the measurement.

3. **Modes of Operation:**

Closed Vial Whole Blood Mode, Whole Blood Mode for venous blood, and Predilute Mode for capillary blood.

4. **Specimen Identification:**

Barcode or manual keyboard entry.

5. **Specimen Sampling and Handling:**

Samples are manually loaded into a sample compartment one at a time. The BC-3200 utilizes an automatic sampling and mixing device for sample processing. The Mindray calibrator is called SC-CAL PLUS.

6. **Calibration:**

The device has two calibration programs: manual calibration and auto calibration using commercial calibrators. The Mindray calibrator is called SC-CAL PLUS.

7. **Quality Control:**

The device has two QC programs: L-J Analysis and X-B Analysis. The Mindray three level control is called BC-3D.

8. **Software:**

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

Yes ☐ X ☐ or No ☐ Mindray has provided software documentation at a moderate level of concern that conforms to the FDA software guidance document.

F. **Regulatory Information:**

1. **Regulation section:**

21 CFR 864.5220, Automated differential cell counter

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2. Classification:

Class II

3 Product code:

GKZ

4. Panel:

Hematology (81)

## G. Intended Use:

1. Indication(s) for Use:

The BC-3200 Auto Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter to be used in clinical laboratories for In Vitro Diagnostic Use. The intended use of the BC-3200 Auto Hematology analyzer is to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies.

2. Special Conditions for Use Statement(s):

N/A

## H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:

COULTER® ACT diff 2™ Analyzer, K0990352

2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The BC-3200 auto hematology analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for In Vitro Diagnostic Use in clinical laboratories. | Same |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Sample Types | Whole Blood Mode and Prediluted Mode | Same |
| Sample Processing | Utilizes an automatic sampling, diluting, and mixing device for sample processing. | Same |
| Calibration | Provides 2 calibration programs: manual calibration and auto calibration using commercial calibrators. | Same |
| Aperture Alert | Minimize the possibility of reporting erroneous results caused by a partial or transient aperture clog or by other aperture disturbance. | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Operating Modes | Closed Vial Whole Blood Mode | Closed Vial Whole Blood Mode and Open Vial Whole Blood Mode |
| Throughput | 1 minute/analysis | 60 seconds or les |
| Quality Control | Provides 2 QC programs: L-J Analysis and X-B Analysis | Provides 1 QC program: L-J Analysis |
| Recommended Controls | BC-3D: Low, Normal, & High | 4C PLUS: Abnormal Low, Normal, Abnormal High |
| Sample Volume Aspirated | 13μL whole blood 20μL prediluted blood | 18μL whole blood 20μl prediluted blood |
| Parameters | WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, Lymph%, Lymph#, Mid%, Mid#, Gran%, Gran#, RDW, MPV | WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, Ly%, Ly#, MO%, MO#, GR%, GR#, RDW, MPV |

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

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. December 4, 2001

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy:

Correlation is determined by comparing the results (both CBC and DIFF) obtained by the BC-3200 to those by the Coulter AC-T diff $2^{\mathrm{TM}}$ and by comparing the DIFF results obtained by the BC-3200 to those by manual differential.

Table 1: Correlation to Coulter $\mathbf{A}^{\mathrm{C}}$-T diff $2^{\mathrm{TM}}$

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Table 2: Correlation to Manual Differential

| Parameter | Samples (n) | Mean | | Difference ratio (D%) | Slope (a) | Intercept (b) | Correlation coefficient (r) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | BC-3200 | A^{e}T diff 2 | | | | |
| WBC | 103 | 10.4 | 10.3 | 2.4 | 1.0097 | -0.0282 | 0.9994 |
| Lymph# | 98 | 1.9 | 2.1 | 11.8 | 0.9918 | -0.1864 | 0.9890 |
| Mid# | 98 | 0.7 | 0.5 | 40.5 | 2.1022 | -0.3798 | 0.9187 |
| Gran# | 98 | 6.1 | 6.0 | 3.7 | 0.9886 | 0.146 | 0.9978 |
| Lymph% | 98 | 25.8 | 29.3 | 11.5 | 0.7935 | 2.5772 | 0.9751 |
| Mid% | 98 | 9.0 | 6.7 | 43.0 | 0.7569 | 3.8798 | 0.4644 |
| Gran% | 98 | 65.2 | 64.0 | 3.4 | 0.9046 | 7.347 | 0.9707 |
| RBC | 103 | 4.31 | 4.27 | 1.7 | 0.9916 | 0.0702 | 0.9971 |
| HGB | 103 | 12.6 | 12.5 | 1.2 | 0.9951 | 0.0853 | 0.9982 |
| HCT | 103 | 37.6 | 37.2 | 2.2 | 1.0041 | 0.2953 | 0.9950 |
| MCV | 103 | 87.8 | 87.5 | 1.2 | 0.9549 | 4.3174 | 0.9824 |
| MCH | 103 | 29.2 | 29.5 | 1.6 | 0.9426 | 1.4345 | 0.9791 |
| MCHC | 103 | 33.3 | 33.7 | 1.8 | 0.7759 | 7.1720 | 0.6784 |
| RDW | 103 | 13.1 | 13.5 | 4.7 | 0.4393 | 7.1667 | 0.9569 |
| PLT | 103 | 226 | 230 | 8.0 | 0.8882 | 21.837 | 0.9961 |
| MPV | 102 | 8.5 | 8.9 | 4.7 | 0.7037 | 2.2287 | 0.9334 |
| Parameter | Samples (n) | Mean | | Slope | Intercept | Correlation Coefficient r |
| --- | --- | --- | --- | --- | --- | --- |
| | | BC-3200 | Manual differential | | | |
| Lymph% | 196 | 26.8 | 30.4 | 0.7575 | 3.7958 | 0.95 |
| Mid% | 196 | 9.2 | 9.0 | 0.3739 | 5.822 | 0.57 |
| Gran% | 196 | 64.0 | 60.6 | 0.8456 | 12.721 | 0.94 |

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# b. Precision/Reproducibility:

Reproducibility is stated in terms of both Standard Deviation (SD) and Coefficient of Variation (CV%). Reproducibility was determined by replicate testing $(n = 11)$ with samples of low, normal and high concentrations, three samples for each concentration. For each sample, results of the 2nd to 11th runs were adopted to calculate the SD and CV%.

Table 3: Imprecision, Low Concentration Samples

| 1 | WBC ×103/ μL | RBC ×106/μL | HGB (g/dL) | MCV (fl) | PLT ×103/μL |
| --- | --- | --- | --- | --- | --- |
| mean | 4.1 | 2.88 | 9.2 | 64.6 | 162 |
| SD | 0.07 | 0.04 | 0.1 | 0.40 | 5.06 |
| CV(%) | 1.63 | 1.45 | 0.8 | 0.62 | 3.12 |
| 2 | WBC ×103/ μL | RBC ×106/μL | HGB (g/dL) | MCV (fl) | PLT ×103/μL |
| mean | 3.2 | 3.02 | 9.3 | 72.9 | 155 |
| SD | 0.03 | 0.03 | 0.1 | 0.21 | 7.02 |
| CV(%) | 0.99 | 1.06 | 1.0 | 0.28 | 4.53 |
| 3 | WBC ×103/ μL | RBC ×106/μL | HGB (g/dL) | MCV (fl) | PLT ×103/μL |
| mean | 3.1 | 1.91 | 5.6 | 61.0 | 61 |
| SD | 0.06 | 0.03 | 0.1 | 0.24 | 5.11 |
| CV(%) | 1.84 | 1.76 | 1.1 | 0.39 | 8.39 |

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Table 4: Imprecision, Normal Concentration Samples

| 1 | WBC ×103/μL | RBC ×106/μL | HGB (g/dL) | MCV (fl) | PLT ×103/μL |
| --- | --- | --- | --- | --- | --- |
| mean | 10.1 | 4.60 | 13.1 | 83.3 | 244 |
| SD | 0.12 | 0.03 | 0.09 | 0.38 | 8.05 |
| CV(%) | 1.18 | 0.73 | 0.7 | 0.45 | 3.30 |
| 2 | WBC ×103/μL | RBC ×106/μL | HGB (g/dL) | MCV (fl) | PLT ×103/μL |
| mean | 9.8 | 5.34 | 15.2 | 83.1 | 249 |
| SD | 0.10 | 0.04 | 0.12 | 0.27 | 4.86 |
| CV(%) | 0.99 | 0.78 | 0.8 | 0.33 | 1.95 |
| 3 | WBC ×103/μL | RBC ×106/μL | HGB (g/dL) | MCV (fl) | PLT ×103/μL |
| mean | 11.3 | 5.27 | 15.0 | 85.9 | 231 |
| SD | 0.13 | 0.04 | 0.06 | 0.21 | 8.53 |
| CV(%) | 1.11 | 0.73 | 0.4 | 0.25 | 3.70 |

Table 5: Imprecision, Normal Concentration Samples

| 1 | WBC ×103/μL | RBC ×106/μL | HGB (g/dL) | MCV (fl) | PLT ×103/μL |
| --- | --- | --- | --- | --- | --- |
| mean | 10.1 | 4.60 | 13.1 | 83.3 | 244 |
| SD | 0.12 | 0.03 | 0.09 | 0.38 | 8.05 |
| CV(%) | 1.18 | 0.73 | 0.7 | 0.45 | 3.30 |
| 2 | WBC ×103/μL | RBC ×106/μL | HGB (g/dL) | MCV (fl) | PLT ×103/μL |
| mean | 9.8 | 5.34 | 15.2 | 83.1 | 249 |
| SD | 0.10 | 0.04 | 0.12 | 0.27 | 4.86 |
| CV(%) | 0.99 | 0.78 | 0.8 | 0.33 | 1.95 |
| 3 | WBC ×103/μL | RBC ×106/μL | HGB (g/dL) | MCV (fl) | PLT ×103/μL |
| mean | 11.3 | 5.27 | 15.0 | 85.9 | 231 |
| SD | 0.13 | 0.04 | 0.06 | 0.21 | 8.53 |
| CV(%) | 1.11 | 0.73 | 0.4 | 0.25 | 3.70 |

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# Inter-laboratory Precision:

Two laboratories, each having one BC-3200 installed, were selected for the test. Three samples of various concentrations (respectively low, normal and high) were prepared, each with sufficient volume to run twice on both of the BC-3200s. Each BC-3200 was operated by one operator, who conducted the test from beginning to the end. Each sample was divided into two aliquots, and the two aliquots were analyzed respectively by the two selected laboratories within the same day of preparation. Each aliquot was run twice on the BC-3200 and both runs were conducted within a short interval. No outlier was found during the test. Based on the data acquired, repeatability variance $(\mathrm{S}^{t2})$ , between laboratory variance $(\mathrm{S}^{j2})$ , and reproducibility variance $(\mathrm{S}_{\mathrm{R}}^2)$ of the following parameters, WBC, RBC, PLT, HGB, Lymph%, Mid% and Gran%, were calculated for ea concentration.

Table 6: Within-run Precision and Total Precision

| | | Low | Normal | High |
| --- | --- | --- | --- | --- |
| WBC×103/ μL | | | | |
| Mean | | 2.13 | 8.10 | 20.68 |
| Repeatability variance | S2r | 0.0025 | 0.0098 | 0.0613 |
| Between Laboratory variance | SL2 | 0.0000 | 0.0151 | 0.0000 |
| Reproducibility variance | SR2 | 0.0025 | 0.0249 | 0.0613 |
| | SR | 0.0500 | 0.1578 | 0.2476 |
| | CV% | 2.35% | 1.95% | 1.20% |
| Gran(%) | | | | |
| Mean | | 32.53 | 60.98 | 81.30 |
| Repeatability variance | S2r | 1.1050 | 0.0221 | 0.0637 |
| Between Laboratory variance | SL2 | 1.7588 | 0.7703 | 0.0932 |
| Reproducibility variance | SR2 | 2.8638 | 0.7924 | 0.1569 |
| | SR | 1.6923 | 0.8902 | 0.3961 |
| | CV% | 5.20% | 1.46% | 0.49% |
| Lymph (%) | | | | |
| Mean | | 12.65 | 28.83 | 51.30 |
| Repeatability variance | S2r | 0.2073 | 0.0613 | 3.0439 |
| Between Laboratory variance | SL2 | 0.0000 | 1.3307 | 6.4781 |

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| Reproducibility variance | SR2 | 0.2073 | 1.3920 | 9.5220 |
| --- | --- | --- | --- | --- |
| | SR | 0.4553 | 1.1798 | 3.0858 |
| | CV% | 3.60% | 4.09% | 6.02% |
| Mid (%) | | | | |
| Mean | | 6.05 | 10.20 | 16.18 |
| Repeatability variance | Sr2 | 0.0490 | 0.0098 | 0.6655 |
| Between Laboratory variance | SL2 | 0.0205 | 0.0751 | 1.3786 |
| Reproducibility variance | SR2 | 0.0695 | 0.0849 | 2.0441 |
| | SR | 0.2636 | 0.2914 | 1.4297 |
| | CV% | 4.36% | 2.86% | 8.84% |
| RBC (×106/μL) | | | | |
| Mean | | 2.48 | 4.89 | 5.80 |
| Repeatability variance | Sr2 | 0.0004 | 0.0065 | 0.0085 |
| Between Laboratory variance | SL2 | 0.0007 | 0.0013 | 0.0000 |
| Reproducibility variance | SR2 | 0.0011 | 0.0078 | 0.0085 |
| | SR | 0.0332 | 0.0883 | 0.0922 |
| | CV% | 1.34% | 1.81% | 1.59% |
| HGB (g/L) | | | | |
| Mean | | 6.35 | 14.08 | 19.13 |
| Repeatability variance | Sr2 | 0.0000 | 0.0025 | 0.0123 |
| Between Laboratory variance | SL2 | 0.0050 | 0.0601 | 0.0952 |
| Reproducibility variance | SR2 | 0.0050 | 0.0626 | 0.1075 |
| | SR | 0.0707 | 0.2502 | 0.3279 |
| | CV% | 1.11% | 1.78% | 1.71% |
| MCV (fl) | | | | |
| Mean | | 77.28 | 86.73 | 96.33 |
| Repeatability variance | Sr2 | 0.1103 | 0.0123 | 0.0907 |
| Between Laboratory variance | SL2 | 2.2562 | 1.5252 | 2.7160 |
| Reproducibility variance | SR2 | 2.3665 | 1.5375 | 2.8067 |
| | SR | 1.5383 | 1.2400 | 1.6753 |
| | CV% | 1.99% | 1.43% | 1.74% |

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Table 6 Appendix

| WBC | Form A | | | Form B | | | Form C | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Laboratory | Low | Normal | High | Low | Normal | High | Low | Normal | High |
| 1 | 2.2 | 8.1 | 20.5 | 2.15 | 8.2 | 20.75 | 0.07 | 0.14 | 0.35 |
| | 2.1 | 8.3 | 21 | | | | | | |
| 2 | 2.1 | 8 | 20.6 | 2.1 | 8 | 20.6 | 0 | 0 | 0 |
| | 2.1 | 8 | 20.6 | | | | | | |
| Gran(%) | Form A | | | Form B | | | Form C | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Laboratory | Low | Normal | High | Low | Normal | High | Low | Normal | High |
| 1 | 32.5 | 60.2 | 81.1 | 31.45 | 60.35 | 81.05 | 1.48 | 0.21 | 0.07 |
| | 30.4 | 60.5 | 81 | | | | | | |
| 2 | 33.5 | 61.6 | 81.8 | 33.6 | 61.6 | 81.55 | 0.14 | 0 | 0.35 |
| | 33.7 | 61.6 | 81.3 | | | | | | |
| Lymph (%) | Form A | | | Form B | | | Form C | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Laboratory | Low | Normal | High | Low | Normal | High | Low | Normal | High |
| 1 | 12.8 | 29.9 | 51.7 | 12.75 | 29.65 | 53.3 | 0.07 | 0.35 | 2.26 |
| | 12.7 | 29.4 | 54.9 | | | | | | |
| 2 | 12.1 | 28 | 50 | 12.55 | 28 | 49.3 | 0.64 | 0 | 0.99 |
| | 13 | 28 | 48.6 | | | | | | |
| Mid (%) | Form A | | | Form B | | | Form C | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Laboratory | Low | Normal | High | Low | Normal | High | Low | Normal | High |
| 1 | 6.1 | 9.9 | 15.8 | 6.2 | 10 | 15.25 | 0.14 | 0.14 | 0.78 |
| | 6.3 | 10.1 | 14.7 | | | | | | |
| 2 | 6.1 | 10.4 | 16.5 | 5.9 | 10.4 | 17.1 | 0.28 | 0 | 0.85 |
| | 5.7 | 10.4 | 17.7 | | | | | | |

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| RBC | Form A | | | Form B | | | Form C | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Laboratory | Low | Normal | High | Low | Normal | High | Low | Normal | High |
| 1 | 2.44 | 4.78 | 5.84 | 2.455 | 4.845 | 5.765 | 0.02 | 0.09 | 0.11 |
| | 2.47 | 4.91 | 5.69 | | | | | | |
| 2 | 2.51 | 4.99 | 5.89 | 2.495 | 4.94 | 5.84 | 0.02 | 0.07 | 0.07 |
| | 2.48 | 4.89 | 5.79 | | | | | | |
| HGB | Form A | | | Form B | | | Form C | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Laboratory | Low | Normal | High | Low | Normal | High | Low | Normal | High |
| 1 | 6.3 | 13.9 | 18.8 | 6.3 | 13.9 | 18.9 | 0 | 0 | 0.14 |
| | 6.3 | 13.9 | 19 | | | | | | |
| 2 | 6.4 | 14.3 | 19.4 | 6.4 | 14.25 | 19.35 | 0 | 0.07 | 0.07 |
| | 6.4 | 14.2 | 19.3 | | | | | | |
| MCV | Form A | Form B | Form C | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Laboratory | Low | Normal | High | Low | Normal | High | Low | Normal | High |
| 1 | 76.5 | 85.9 | 95.2 | 76.2 | 85.85 | 95.15 | 0.42 | 0.07 | 0.07 |
| | 75.9 | 85.8 | 95.1 | | | | | | |
| 2 | 78.5 | 87.5 | 97.8 | 78.35 | 87.6 | 97.5 | 0.21 | 0.14 | 0.42 |
| | 78.2 | 87.7 | 97.2 | | | | | | |
| PLT | Form A | | | Form B | | | Form C | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Laboratory | Low | Normal | High | Low | Normal | High | Low | Normal | High |
| 1 | 88 | 265 | 466 | 91.5 | 264.5 | 462.5 | 4.95 | 0.71 | 4.95 |
| | 95 | 264 | 459 | | | | | | |
| 2 | 97 | 248 | 474 | 98 | 252 | 474.5 | 1.41 | 5.66 | 0.71 |
| | 99 | 256 | 475 | | | | | | |

# c. Linearity:

Linearity was determined by running diluted samples. RBC,HGB are diluted by blood plasma of the sample, while WBC and PLT are diluted by specified diluent. Concentrations from 0 to $100\%$ were tested, each concentration twice. The average of the two runs is taken as the result, together with the concentration, to calculate per the linear regression equation.

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Table 7: WBC Linearity

| Dilution% | Test 1 | Test 2 | Mean | Ideal | Error | Proportional Error |
| --- | --- | --- | --- | --- | --- | --- |
| 100 | 117.1 | 115.9 | 116.50 | 120.01 | 3.51 | 2.9 |
| 80 | 99.8 | 100.1 | 99.95 | 96.01 | -3.94 | -4.1 |
| 60 | 73.4 | 72.1 | 72.75 | 72.00 | -0.75 | -1.0 |
| 40 | 47.8 | 48.6 | 48.20 | 48.00 | -0.20 | -0.4 |
| 20 | 23.1 | 23.1 | 23.10 | 23.99 | 0.89 | 3.7 |
| 10 | 12.1 | 12.0 | 12.05 | 11.99 | -0.06 | -0.5 |
| 5 | 6.0 | 6.2 | 6.10 | 6.00 | -0.10 | -1.7 |
| 2.5 | 3.0 | 2.9 | 2.95 | 2.99 | 0.04 | 1.3 |
| 1.25 | 1.3 | 1.3 | 1.30 | 1.49 | 0.19 | 12.8 |
| 0.625 | 0.5 | 0.5 | 0.50 | 0.74 | 0.24 | 32.4 |
| 0.3125 | 0.2 | 0.1 | 0.15 | 0.36 | 0.21 | 58.3 |
| 0 | 0 | 0 | 0.00 | -0.01 | -0.01 | / |
| Slope | 1.2002 | | | | | |
| Intercept | -0.0129 | | | | | |

Table 8: RBC Linearity

| Dilution% | Test 1 | Test 2 | Mean | Ideal | Error | Proportional Error |
| --- | --- | --- | --- | --- | --- | --- |
| 100 | 8.46 | 8.43 | 8.445 | 8.519 | 0.074 | 0.9 |
| 80 | 6.91 | 6.86 | 6.885 | 6.819 | -0.066 | -1.0 |
| 60 | 5.12 | 5.17 | 5.145 | 5.119 | -0.026 | -0.5 |
| 40 | 3.42 | 3.46 | 3.440 | 3.419 | -0.021 | -0.6 |
| 20 | 1.71 | 1.69 | 1.700 | 1.719 | 0.019 | 1.1 |
| 10 | 0.89 | 0.87 | 0.880 | 0.869 | -0.011 | -1.3 |
| 5 | 0.46 | 0.46 | 0.460 | 0.444 | -0.016 | -3.6 |
| 2.5 | 0.21 | 0.22 | 0.215 | 0.232 | 0.017 | 7.3 |
| 1.25 | 0.10 | 0.13 | 0.115 | 0.125 | 0.010 | 8.0 |
| 0 | 0.00 | 0.00 | 0.000 | 0.019 | 0.019 | / |
| Slope | 0.0850 | | | | | |
| Intercept | 0.0191 | | | | | |

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Table 9: HGB Linearity

| Dilution% | Test 1 | Test 2 | Mean | Ideal | Error | Proportional Error |
| --- | --- | --- | --- | --- | --- | --- |
| 100 | 25.6 | 25.6 | 25.60 | 25.40 | -0.20 | -0.8 |
| 80 | 20.5 | 20.1 | 20.30 | 20.33 | 0.03 | 0.1 |
| 60 | 15.1 | 14.9 | 15.00 | 15.26 | 0.26 | 1.7 |
| 40 | 10.1 | 10.1 | 10.10 | 10.19 | 0.09 | 0.9 |
| 20 | 5.2 | 5.0 | 5.10 | 5.11 | 0.01 | 0.2 |
| 10 | 2.7 | 2.6 | 2.65 | 2.58 | -0.07 | -2.7 |
| 5 | 1.4 | 1.4 | 1.40 | 1.31 | -0.09 | -6.9 |
| 2.5 | 0.7 | 0.7 | 0.70 | 0.68 | -0.02 | -2.9 |
| 1.25 | 0.4 | 0.4 | 0.40 | 0.36 | -0.04 | -11.1 |
| 0 | 0.0 | 0.0 | 0.00 | 0.04 | 0.04 | / |
| Slope | 0.2536 | | | | | |
| Intercept | 0.0425 | | | | | |

Table 10: PLT Linearity

| Dilution% | Test 1 | Test 2 | Mean | Ideal | Error | Proportional Error |
| --- | --- | --- | --- | --- | --- | --- |
| 100 | 1014 | 1008 | 1011.0 | 1040.3 | 29.3 | 2.8 |
| 80 | 850 | 858 | 854.0 | 832.5 | -21.5 | -2.6 |
| 60 | 631 | 650 | 640.5 | 624.8 | -15.7 | -2.5 |
| 40 | 425 | 419 | 422.0 | 417.0 | -5.0 | -1.2 |
| 20 | 221 | 208 | 214.5 | 209.3 | -5.2 | -2.5 |
| 10 | 109 | 101 | 105.0 | 105.4 | 0.4 | 0.4 |
| 5 | 53 | 53 | 53.0 | 53.5 | 0.5 | 0.9 |
| 2.5 | 23 | 17 | 20.0 | 27.5 | 7.5 | 27.3 |
| 1.25 | 8 | 5 | 6.5 | 14.5 | 8.0 | 55.2 |
| 0 | 0 | 0 | 0.0 | 1.6 | 1.6 | / |
| Slope | 10.3871 | | | | | |
| Intercept | 1.5618 | | | | | |

# d. Carryover:

Carryover was determined by first running the high concentration sample for three consecutive times (i1, i2, i3) and then the low concentration sample three consecutive times (j1, j2, j3), and finally calculating per the following equation: Carryover $(\%) = [(j1 - j3) / (i3 - j3)] \times 100\%$ . The test was then repeated using the high level control.

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Table 11: Carryover, High Concentration Sample

| Parameter | High Concentration Sample (Whole Blood) | | | Low Concentration Sample (Whole Blood) | | | Carryover % |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | i1 | i2 | i3 | j1 | j2 | j3 | |
| WBC(×103/μL) | 19.7 | 20.4 | 20.0 | 1.9 | 1.9 | 1.9 | 0% |
| RBC(×106/μL) | 6.34 | 6.24 | 6.2 | 1.87 | 1.96 | 1.85 | 0.46% |
| HGB(g/dL) | 25.4 | 25.0 | 24.8 | 3.3 | 3.2 | 3.2 | 0.46% |
| PLT(×103/μL) | 404 | 390 | 396 | 31 | 34 | 33 | 0% |

Table 12: Carryover, High Level Control

| Parameter | High Concentration Sample (High Level Control) | | | Low Concentration Sample (Specified Diluent) | | | Carryover % |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | i1 | i2 | i3 | j1 | j2 | j3 | |
| WBC(×103/μL) | 21.7 | 21.3 | 21.7 | 0.0 | 0.0 | 0.0 | 0% |
| RBC(×106/μL) | 5.88 | 5.79 | 5.79 | 0.00 | 0.00 | 0.00 | 0% |
| HGB(g/dL) | 18.8 | 18.7 | 18.9 | 0.0 | 0.0 | 0.0 | 0% |
| PLT(×103/μL) | 453 | 438 | 429 | 0 | 0 | 0 | 0% |

e. Interfering Substances:

N/A

2. Other Supportive Instrument Performance Data Not Covered Above:

Ability to Flag Abnormal Histograms:

BC-3200's ability to flag abnormal WBC histograms was determined by comparing 200 sample results obtained by the BC-3200 to those obtained by manual differential.

Table 13: Ability to Flag Abnormal WBC Histograms

| Manual differential | BC-3200 | |
| --- | --- | --- |
| | Positive (39) | Negative (161) |
| Positive (40) | TP □22□ | FN □18□ |
| Negative (160) | FP □17□ | TN □143□ |
| Agreement% | False Positive Ratio (%) | False Negative Ratio (%) |
| 82.5 | 10.6 | 45 |

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# Reference Ranges

A Normal Ranges Study was conducted to assess the Reference Ranges for the BC-3200 analyzer. Whole-blood samples were collected from 121 donors.

Table 14: Reference Ranges

| Parameter | Units | Sex | Mean | 90% Confidence Low Limit | 90% Confidence High Limit |
| --- | --- | --- | --- | --- | --- |
| WBC | ×103cells /μL | M/F | 6.86 | 3.47 | 10.25 |
| RBC | ×106cells /μL | M/F | 4.56 | 3.54 | 5.58 |
| Hgb | g/ dL | M/F | 13.40 | 10.27 | 16.52 |
| Hct | ratio | M/F | 40.12 | 30.98 | 49.26 |
| MCV | fL | M/F | 88.18 | 80.82 | 95.55 |
| MCH | pg | M/F | 29.36 | 26.57 | 32.15 |
| MCHC | g/ dL | M/F | 33.33 | 32.09 | 34.56 |
| Plt | ×103cells/μL | M/F | 209.92 | 119.62 | 300.22 |
| RDW | % | M/F | 12.81 | 11.53 | 14.10 |
| MPV | fL | M/F | 8.47 | 7.07 | 9.87 |
| LY | % | M/F | 27.33 | 18.11 | 36.55 |
| MO | % | M/F | 9.45 | 5.23 | 13.67 |
| GR | % | M/F | 63.26 | 51.62 | 74.89 |

# 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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