(214 days)
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.
The BC-3200 Auto Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential 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 to flag or identify patient results that require additional studies. The analyzer provides analysis results of 16 parameters (listed below) of human blood and three histograms.
| Parameter | Abbreviation |
|---|---|
| White Blood Cell or leukocyte | WBC |
| Lymphocyte | Lymph# |
| Mid-sized cell | Mid# |
| Granulocyte | Gran# |
| Lymphocyte percentage | Lymph% |
| Mid-sized cell percentage | Mid% |
| Granulocyte percentage | Gran% |
| Red Blood Cell or erythrocyte | RBC |
| Hemoglobin Concentration | HGB |
| Mean Corpuscular (erythrocyte) Volume | MCV |
| Mean Cell (erythrocyte) Hemoglobin | MCH |
| Mean Cell (erythrocyte) Hemoglobin Concentration | MCHC |
| Red Blood Cell (erythrocyte) Distribution Width | RDW |
| Hematocrit | HCT |
| Platelet | PLT |
| Mean Platelet Volume | MPV |
| White Blood Cell Histogram | WBC Histogram |
|---|---|
| Red Blood Cell Histogram | RBC Histogram |
| Platelet Histogram | PLT Histogram |
The BC-3200 Auto Hematology Analyzer system consists of the analyzer, reagents (M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E E-Z CLEANSER and M-30P PROBE CLEANSER), controls (BC-3D Hematology Control), calibrator (SC-CAL PLUS Hematology Calibrator) and accessories.
The two independent measurement methods used in this analyzer are: the Coulter method for determining the WBC, RBC, and PLT data and the colorimetric method for determining the HGB.
Acceptance Criteria and Device Performance Study for BC-3200 Auto Hematology Analyzer
This document summarizes the acceptance criteria and study findings for the BC-3200 Auto Hematology Analyzer, as described in the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria detailed in the document are primarily derived from comparisons to a legally marketed predicate device (COULTER® A.T diff 2TM Analyzer) and general performance expectations for hematology analyzers. The reported device performance is presented in various tables throughout the summary.
Performance Parameters and Criteria (Derived from Predicate Device Comparison & Industry Standards):
| Performance Characteristic | Acceptance Criteria (from Predicate/Industry Std) | BC-3200 Reported Performance | Section in Document |
|---|---|---|---|
| Reproducibility | |||
| WBC (%CV) | ≤3.0% (for 6.0-15.0 x 10^3 /μL) | 0.93 - 1.85% | Table 1, 2, 3 |
| RBC (%CV) | ≤3.0% (for 3.00-6.00 x 10^6 /μL) | 0.60 - 1.76% | Table 1, 2, 3 |
| HGB (%CV) | ≤2.0% (for 12.0-18.0 g/dL) | 0.4 - 1.1% | Table 1, 2, 3 |
| MCV (%CV) | ≤3.0% (for 80.0-100.0 fL) | 0.25 - 0.62% | Table 1, 2, 3 |
| PLT (%CV) | ≤7.0% (for 200-500 x 10^3 /μL) | 1.58 - 8.39% | Table 1, 2, 3 |
| Inter-Laboratory Precision | Not explicitly stated as a numerical criterion compared to predicate. Implied to be acceptable if variability is low. | CV% ranges shown for WBC (1.20-2.35%), Gran (0.49-5.20%), Lymph (3.60-6.02%), Mid (2.86-8.84%), RBC (1.34-1.81%), HGB (1.11-1.78%), MCV (1.43-1.99%), PLT (1.89-5.56%). | Table 4 |
| Linearity | |||
| WBC | ±0.3 or ±5% (0-99.9 x 10^3 /μL) | All reported error percentages are within ±5% where absolute error is not applicable, or less than 3.94 for samples in the middle range. | Table 5 |
| RBC | ±0.05 or ±5% (0-7.0 x 10^6 /μL) | All errors are within ±5%. | Table 6 |
| HGB | ±0.2 or ±3% (0-25.0 g/dL) | All errors are within ±3%. | Table 7 |
| PLT | ±10 or ±10% (0-999 x 10^3 /μL) | All errors are within ±10%. | Table 8 |
| Carryover | |||
| WBC | ≤2.0% | 0% | Table 9, 10 |
| RBC | ≤2.0% | 0.46% (whole blood), 0% (control) | Table 9, 10 |
| HGB | ≤2.0% | 0.46% (whole blood), 0% (control) | Table 9, 10 |
| PLT | ≤2.0% | 0% | Table 9, 10 |
| Correlation to Predicate Device | Correlation coefficient (r) close to 1, slope close to 1, intercept close to 0, mean difference acceptable. Specific criteria are not explicitly stated but implied by comparison. | WBC: r=0.9994, Slope=1.0097; RBC: r=0.9971, Slope=0.9916; HGB: r=0.9982, Slope=0.9951; PLT: r=0.9961, Slope=0.8882. Other parameters also show strong correlations (mostly >0.97). | Table 11 |
| Correlation to Manual Differential | Correlation coefficient (r) close to 1. Specific criteria not explicitly stated. | Lymph%: r=0.95; Mid%: r=0.57; Gran%: r=0.94 | Table 12 |
| Ability to Flag Abnormal WBC Histograms | Not explicitly stated, but high agreement and low false negative rates are desirable. The predicate device's flagging ability would be the implicit benchmark. | Agreement (%): 82.5; False Positive Ratio (%): 10.6; False Negative Ratio (%): 45 | Table 13 |
2. Sample Sizes and Data Provenance
- Test Set Sample Sizes:
- Reproducibility (Imprecision): 11 replicate tests for each of nine samples (three low, three normal, three high concentrations).
- Inter-Laboratory Precision: Three samples (low, normal, high concentrations), each run twice on two BC-3200 devices in two different laboratories.
- Linearity: Diluted samples tested at multiple concentrations (from 0% to 100%), each concentration run twice. The exact number of initial samples before dilution is not specified.
- Carryover: High concentration sample run three times (i1, i2, i3), then low concentration sample run three times (j1, j2, j3). Repeated for high-level control.
- Correlation to Predicate Device: Ranges from 98 to 103 samples depending on the parameter (e.g., 103 for WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW; 98 for Lymph#, Mid#, Gran#, Lymph%, Mid%, Gran%; 102 for MPV).
- Correlation to Manual Differential: 196 samples.
- Abnormal WBC Histograms Flagging: 200 samples.
- Reference Ranges: 121 donors.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the submitter's location (Shenzhen, P. R. China) and the context of a 510(k) submission, it is likely that parts of the studies were conducted in China and/or possibly in collaboration with clinical sites. The studies appear to be prospective for performance characterization (e.g., reproducibility, linearity) and likely involved prospective collection of samples for correlation and flagging studies.
3. Number of Experts and Qualifications for Ground Truth
- Correlation to Manual Differential: The document implies that manual differential counts were performed by experts to establish ground truth for the 196 samples. The number of experts and their specific qualifications (e.g., years of experience as a clinical pathologist or medical technologist performing manual differentials) are not specified.
- Ability to Flag Abnormal WBC Histograms: Similarly, manual differential was used as the ground truth for flagging abnormal WBC histograms for 200 samples. The number of experts and their qualifications are not specified.
4. Adjudication Method
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for establishing ground truth in any of the studies (e.g., manual differential counts). It is implied that a single expert or standard laboratory practice was used for manual differentials.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or performed. The studies focus on comparing the device's performance to a predicate device and manual methods, not on how human readers' performance improves with or without AI assistance. The device in question (BC-3200 Auto Hematology Analyzer) is an automated hematology analyzer, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study
Yes, standalone performance studies were extensively conducted. The entire "Performance characteristics" section (starting from [2]) describes the algorithm-only performance of the BC-3200 Auto Hematology Analyzer. This includes:
- Reproducibility: Testing the consistency of the device's measurements.
- Inter-Laboratory Precision: Assessing variability across different devices/laboratories.
- Linearity: Evaluating the device's accuracy across different concentration ranges.
- Carryover: Measuring the residual effect from a previous high-concentration sample.
- Correlation: Comparing the device's results to a predicate device and manual methods.
- Ability to flag abnormal WBC histograms: Assessing the device's automated flagging capability.
- Reference Ranges: Establishing normal ranges for the device.
All these studies demonstrate the standalone performance of the BC-3200 without human-in-the-loop performance modifications.
7. Type of Ground Truth Used
The types of ground truth used include:
- Reference values from highly controlled measurements/calibrators: For reproducibility and linearity studies, where the true value is often defined by precise dilutions or calibrated controls.
- Predicate device measurements: For correlation studies against the COULTER® A.T diff 2TM Analyzer (Table 11).
- Expert Consensus / Expert Manual Differential: For correlation of differential counts (Lymph%, Mid%, Gran%) and for evaluating the ability to flag abnormal WBC histograms (Table 12 and 13). This is typically established by trained laboratory personnel performing microscopic examination and enumeration.
- Donor Samples: For establishing reference ranges (Table 14).
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" or "test set" in the context of machine learning model development. This is an automated hematology analyzer, not an AI/ML-based diagnostic system that would typically undergo distinct training and testing phases with labeled datasets in the machine learning sense. The described studies are performance validation studies which effectively act as a test set for the device's overall design and algorithm, but there isn't a separate, large, labeled dataset used specifically for "training" an AI model in the conventional sense.
9. How the Ground Truth for the Training Set was Established
As mentioned above, the device is an automated hematology analyzer utilizing the Coulter method and colorimetric method, not an AI/ML system that requires a training set in the typical sense. Therefore, the concept of establishing ground truth for a training set does not directly apply to the information provided in this 510(k) summary. The ground truth for the performance validation studies was established through the methods described in point 7.
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
063407 The assigned 510(k) number is:
Submitter:
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Tel: +86 755 2658 2888
Fax: +86 755 2658 2680
● Contact Person:
Li Dongling Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
- Date Prepared:
Oct. 20, 2006
Name of the device:
- Trade/Proprietary Name: BC-3200 Auto Hematology Analyzer
- Common Name: Automated Differential Cell Counter
- Classification
21 CFR&864.5220 Automated Differential Cell Counter Class II
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Legally Marketed Predicate Device:
K#990352, COULTER® A . T diff 2TM Analyzer, Coulter Corporation.
Description:
The BC-3200 Auto Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential 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 to flag or identify patient results that require additional studies. The analyzer provides analysis results of 16 parameters (listed below) of human blood and three histograms.
| Parameter | Abbreviation |
|---|---|
| White Blood Cell or leukocyte | WBC |
| Lymphocyte | Lymph# |
| Mid-sized cell | Mid# |
| Granulocyte | Gran# |
| Lymphocyte percentage | Lymph% |
| Mid-sized cell percentage | Mid% |
| Granulocyte percentage | Gran% |
| Red Blood Cell or erythrocyte | RBC |
| Hemoglobin Concentration | HGB |
| Mean Corpuscular (erythrocyte) Volume | MCV |
| Mean Cell (erythrocyte) Hemoglobin | MCH |
| Mean Cell (erythrocyte) Hemoglobin Concentration | MCHC |
| Red Blood Cell (erythrocyte) Distribution Width | RDW |
| Hematocrit | HCT |
| Platelet | PLT |
| Mean Platelet Volume | MPV |
| White Blood Cell Histogram | WBC Histogram |
|---|---|
| Red Blood Cell Histogram | RBC Histogram |
| Platelet Histogram | PLT Histogram |
The BC-3200 Auto Hematology Analyzer system consists of the analyzer, reagents (M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E E-Z CLEANSER and M-30P PROBE CLEANSER), controls (BC-3D Hematology Control), calibrator (SC-CAL PLUS Hematology Calibrator) and accessories.
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Performance of the system depends on the combined integrity of all components.
The two independent measurement methods used in this analyzer are: the Coulter method for determining the WBC, RBC, and PLT data and the colorimetric method for determining the HGB.
Statement of intended Use:
The BC-3200 auto hematology analyzer is a quantitative, automated hematology analyzer and leukocvte 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.
Performance characteristics:
Reproducibility ●
Reproducibility is stated in terms of both Standard Deviation (SD) and Coefficient of Variation (CV%).Reproducibility was deterrmined by replicate testing(n = 11)with samples of low, normal and high concentrations,three samples for each concentration.For each sample,results ofthe 2nd to 11th runs were adopted to calculate the SD and CV % . See Table 1 to Table 3 .
| WBC | RBC | HGB | MCV | PLT | |
|---|---|---|---|---|---|
| 1 | ( $\times10^3 / \muL$ ) | ( $\times10^6 / \muL$ ) | (g/dL) | (fl) | ( $\times10^3 / \muL$ ) |
| 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 | ( $\times10^3 / \muL$ ) | ( $\times10^6 / \muL$ ) | (g/dL) | (fl) | ( $\times10^3 / \muL$ ) |
| 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 | ( $\times10^3 / \muL$ ) | ( $\times10^6 / \muL$ ) | (g/dL) | (fl) | ( $\times10^3 / \muL$ ) |
| 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 |
Table 1 Imprecision , low concentration samples
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| 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 2 Imprecision , normal concentration samples
| WBC | RBC | HGB | MCV | PLT | |
|---|---|---|---|---|---|
| 1 | (×103/μL) | (×106/μL) | (g/dL) | (fl) | (×103/μL) |
| mean 16.7 | 6.98 | 22.4 | 112.1 | 419 | |
| SD 0.31 | 0.09 | 0.2 | 0.79 | 9.73 | |
| CV(%) 1.85 | 1.24 | 0.7 | 0.71 | 2.32 | |
| 2 | WBC | RBC | HGB | MCV | PLT |
| (×103/μL) | (×106/μL) | (g/dL) | (fl) | (×103/μL) | |
| mean 25.1 | 6.22 | 18.8 | / | 408 | |
| SD 0.26 | 0.05 | 0.2 | / | 6.45 | |
| CV(%) 1.03 | 0.84 | 0.8 | / | 1.58 | |
| 3 | WBC | RBC | HGB | MCV | PLT |
| (×103/μL) | (×106/μL) | (g/dL) | (fl) | (×103/μL) | |
| mean 18.5 | 6.09 | 18.0 | / | 495 | |
| SD 0.17 | 0.04 | 0.2 | / | 11.44 | |
| CV(%) 0.93 | 0.60 | 0.8 | / | 2.31 |
Table 3 Imprecision , high concentration samples
● Iner-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
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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 (S), between laboratory variance ( S ), and reproducibility variance ( P ) of the following parameters, WBC, RBC, HGB, MCV , PLT, Lymph%, Mid% and Gran%, were calculated for each concentration. The inter-laboratory precision see table 4.
| Low | Normal | High | ||
|---|---|---|---|---|
| WBC ( $\times 10^3 / \mu L$ ) | ||||
| Mean | 2.13 | 8.10 | 20.68 | |
| Repeatability variance | $S_r^2$ | 0.0025 | 0.0098 | 0.0613 |
| Between Laboratory variance | $S_L^2$ | 0.0000 | 0.0151 | 0.0000 |
| Reproducibility variance | $S_R^2$ | 0.0025 | 0.0249 | 0.0613 |
| $S_R$ | 0.0500 | 0.1578 | 0.2476 | |
| CV% | 2.35% | 1.95% | 1.20% | |
| Gran (%) | ||||
| Mean | 32.53 | 60.98 | 81.30 | |
| Repeatability variance | $S_r^2$ | 1.1050 | 0.0221 | 0.0637 |
| Between Laboratory variance | $S_L^2$ | 1.7588 | 0.7703 | 0.0932 |
| Reproducibility variance | $S_R^2$ | 2.8638 | 0.7924 | 0.1569 |
| $S_R$ | 1.6923 | 0.8902 | 0.3961 | |
| CV% | 5.20% | 1.46% | 0.49% | |
| Lymph (%) | ||||
| Mean | 12.65 | 28.83 | 51.30 | |
| Repeatability variance | $S_r^2$ | 0.2073 | 0.0613 | 3.0439 |
| Between Laboratory variance | $S_L^2$ | 0.0000 | 1.3307 | 6.4781 |
| $S_R^2$ | 0.2073 | 1.3920 | 9.5220 | |
| Reproducibility variance | $S_R$ | 0.4553 | 1.1798 | 3.0858 |
| CV% | 3.60% | 4.09% | 6.02% | |
| Mid (%) | ||||
| Mean | 6.05 | 10.20 | 16.18 | |
| Repeatability variance | $S_r^2$ | 0.0490 | 0.0098 | 0.6655 |
| Between Laboratory variance | $S_L^2$ | 0.0205 | 0.0751 | 1.3786 |
| $S_R^2$ | 0.0695 | 0.0849 | 2.0441 | |
| Reproducibility variance | $S_R$ | 0.2636 | 0.2914 | 1.4297 |
| CV% | 4.36% | 2.86% | 8.84% | |
| RBC ( $\times 10^6 / \mu L$ ) | ||||
| Mean | 2.48 | 4.89 | 5.80 | |
| Repeatability variance | $S_r^2$ | 0.0004 | 0.0065 | 0.0085 |
| Between Laboratory variance | $S_L^2$ | 0.0007 | 0.0013 | 0.0000 |
| $S_R^2$ | 0.0011 | 0.0078 | 0.0085 | |
| Reproducibility variance | $S_R$ | 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 | $S_r^2$ | 0.0000 | 0.0025 | 0.0123 |
| Between Laboratory variance | $S_L^2$ | 0.0050 | 0.0601 | 0.0952 |
| $S_R^2$ | 0.0050 | 0.0626 | 0.1075 | |
| Reproducibility variance | $S_R$ | 0.0707 | 0.2502 | 0.3279 |
| CV% | 1.11% | 1.78% | 1.71% | |
| MCV (fL) | ||||
| 77.28 | 86.73 | 96.33 | ||
| Mean | ||||
| Repeatability variance | $S_r^2$ | 0.1103 | 0.0123 | 0.0907 |
| Between Laboratory variance | $S_L^2$ | 2.2562 | 1.5252 | 2.7160 |
| Reproducibility variance | $S_R^2$ | 2.3665 | 1.5375 | 2.8067 |
| $S_R$ | 1.5383 | 1.2400 | 1.6753 | |
| CV% | 1.99% | 1.43% | 1.74% | |
| PLT (×103 /μL) | ||||
| Mean | 94.75 | 258.25 | 468.50 | |
| Repeatability variance | $S_r^2$ | 13.2453 | 16.2699 | 12.5033 |
| Between Laboratory variance | $S_L^2$ | 14.5024 | 69.9901 | 65.7484 |
| Reproducibility variance | $S_R^2$ | 27.7477 | 86.2600 | 78.2517 |
| $S_R$ | 5.2676 | 9.2876 | 8.8460 | |
| CV% | 5.56% | 3.60% | 1.89% |
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Table 4 Within-run precision and total precision
Appendix of Table 4:
| 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 |
| 1 | 30.4 | 60.5 | 81 | ||||||
| 2 | 33.5 | 61.6 | 81.8 | 33.6 | 61.6 | 81.55 | 0.14 | 0 | 0.35 |
| 2 | 33.7 | 61.6 | 81.3 |
| Lymph (%) | Form A | Form B | Form C | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Laboratory | Low | Normal | High | Low | Normal | High | Low | Normal | High |
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| 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 |
| 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 | Laboratory | Form A | Form B | Form C | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
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● 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 . See Table 5 to Table 8 .
| Dilution (%) | Test 1 | Test 2 | Mean | Ideal | Error | Proportionalerror |
|---|---|---|---|---|---|---|
| 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 | / |
| 0 | 0 | 0 | 0.00 | -0.01 | -0.01 | |
| Slope | 1.2002 | |||||
| Intercept | -0.0129 |
| Table 5 WBC Linearity | |||
|---|---|---|---|
| -- | -- | -- | ----------------------- |
| Dilution (%) | Test 1 | Test 2 | Mean | Ideal | Error | Proportionalerror |
|---|---|---|---|---|---|---|
| 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 |
{9}------------------------------------------------
Intercept
0.0191
| Dilution (%) | Test 1 | Test 2 | Mean | Ideal | Error | Proportionalerror |
|---|---|---|---|---|---|---|
| 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 6 RBC Linearity
Table 7 HGB Linearity
| Dilution (%) | Test 1 | Test 2 | Mean | Ideal | Error | Proportionalerror | |
|---|---|---|---|---|---|---|---|
| 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 |
Table 8 PLT Linearity
Carryover .
Carryover was determined by first running the high concentration sample for
{10}------------------------------------------------
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)]× 100%
The test was then repeated using the high level control. See Table 9 and Table 10.
| Parameter | High concentration sample (whole blood) | Low concentration sample (whole blood) | Carryover % | ||||
|---|---|---|---|---|---|---|---|
| i1 | i2 | i3 | j1 | j2 | j3 | ||
| WBC( $\times 10^3 / \mu L$ ) | 19.7 | 20.4 | 20.0 | 1.9 | 1.9 | 1.9 | 0% |
| RBC( $\times 10^6 / \mu L$ ) | 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( $\times 10^3 / \mu L$ ) | 404 | 390 | 396 | 31 | 34 | 33 | 0% |
Table 9 Carryover, high concentration sample
| High concentration | Low concentration | |||||||
|---|---|---|---|---|---|---|---|---|
| Parameter | sample (high level | sample (specified | Carryover % | |||||
| control) | diluent) | |||||||
| 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% |
Table 10 Carryover, high level control
. Correlation
Correlation is determined by comparing the results ( both CBC and DIFF ) obtained by the BC-3200 to those by the Coulter AS-T diff 2"M and by comparing the DIFF results obtained by the BC-3200 to those by manual differential . See Table 11 and Table 12 .
| Parameters | Sample(n) | Mean | Differenceratio(D%) | Slope(a) | Intercept(b) | Correlationcoefficients | |
|---|---|---|---|---|---|---|---|
| BC-3200 | A o. Tdiiff 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 | 0.1460 | 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 |
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| Gran% | 98 | 65.2 | 64.0 | 3.4 | 0.9046 | 7.3470 | 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 |
Table 11 Correlation to Coulter A •T diff 2TM
| Parameter | Samples(n) | Mean | Slope(a) | Intercept(b) | Correlationcoefficient(r) | |
|---|---|---|---|---|---|---|
| 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 |
Table 12 Correlation to manual differential
● Ability to flag abnormal WBC 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 diferential.See Table 13.
| Manualdifferential | 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 |
Table 13 Ability to flag abnormal WBC histograms
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.
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| 90%Confidence | 90%Confidence | ||||
|---|---|---|---|---|---|
| Parameter | Units | Sex | Mean | Low Limit | 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 | % | 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 | ×10³ cells /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 |
| Lymph | % | M/F | 27.33 | 18.11 | 36.55 |
| Mid | % | M/F | 9.45 | 5.23 | 13.67 |
| Gran | % | M/F | 63.26 | 51.62 | 74.89 |
Normal Population Study
Table 14 Reference Range
Comparison of Technological Characteristics:
Compare the BC-3200 Auto Hematology Analyzer to COULTER® Aº·T diff 2TM Analyzer
| NO | Feature | BC-3200 AutoHematology Analyzer | COULTER® AC·T diff2TM Analyzer |
|---|---|---|---|
| • | |||
| 1 | Intended Use | The BC-3200 autohematology analyzer is aquantitative, automatedhematology analyzer andleukocyte differentialcounter for In VitroDiagnostic Use inclinical laboratories. | The COULTER® AC·Tdiff 2TM Analyzer is aquantitative, automatedhematology analyzerand leukocytedifferential counter ForIn Vitro Diagnostic Usein clinical laboratories. |
| 2 | Sample Types | Whole Blood Mode andPrediluted Mode | Whole blood modeand Prediluted mode |
| 3 | Operating Modes | Closed Vial WholeBlood mode | Open Vial Whole Bloodmode and Closed VialWhole Blood mode |
| 4 | Throughput | 1 minute / analysis | 60 seconds or less |
| 5 | Reagents Required | M-30D DILUENT;M-30R RINSE;M-30CFL LYSE;M-30ECLEANSER;M-30PCLEANSER | dff AC.T Park or diff AC.T Tain reagent park,both of which containdiluent and lytic reagent.E-Z AC.T Rinse ShutdownPROBE Diluent |
| 6 | Operating Rage | ||
| WBC | 0.0 - 299.9 ( $\times$ 103/μL) | 0.0-150 ( $\times$ 103/μL) | |
| RBC | 0.00 - 19.99 ( $\times$ 106/μL) | 0.00-8.00 ( $\times$ 106/μL) | |
| HGB | 0 - 29.9 ( $\times$ g/dL) | 0.00-30.0 ( $\times$ g/dL) | |
| PLT | 0 - 2999 ( $\times$ 103/μL) | 000-3000 ( $\times$ 103/μL) | |
| MCV | 0.0-249.9fL | 50.0-130.0 fL | |
| 7 | Background Counts | ||
| WBC | 0.3 $\times$ 103 /µL or less | 0.4 $\times$ 103 /µL or less | |
| RBC | 0.03 $\times$ 106 /µL or less | 0.04 $\times$ 106 /µL or less | |
| HGB | 0.1 g/dL or less | 0.2 g/dL or less | |
| PLT | 10 $\times$ 103 /µL or less | 7.0 $\times$ 103 /µL or less | |
| 8 | Reproducibility | ||
| WBC | 7.0-15.0 $\times$ 103 /μL3.0% or less | 6.0-15.0 $\times$ 103 /μL3.0% or less | |
| RBC | 3.50-6.00 $\times$ 106 /μL2.5% or less | 3.00-6.00 $\times$ 106 /μL3.0% or less | |
| HGB | 11.0-18.0 g/dL2.0% or less | 12.0-18.0 g/dL2.0% or less | |
| MCV | 80.0-110.0 fL2.0% or less | 80.0-100.0 fL3.0% or less | |
| PLT | 200-400 $\times$ 103 /μL6.0% or less | 200-500 $\times$ 103 /μL7.0% or less | |
| 9 | Linearity | ||
| WBC | 0.3-99.9 ( $\times$ 103/μL)±0.3 or ±5% | 0 – 99.9( $\times$ 103/μL)±0.3 or ±5% | |
| RBC | 0.20 -7.99( $\times$ 106/μL)±0.05 or ±5% | 0 - 7.0( $\times$ 106/μL)±0.05 or ±5.0% | |
| HGB | 1.0-24.9 (g/dL)±0.2or ±3% | 0 - 25.0 (g/dL)±0.2 or ±3.0% | |
| PLT | 10-999( $\times$ 103/μL)±10 or ±10% | 0 - 999 ( $\times$ 103/μL)±10.0 or ±10.0% | |
| 10 | Carryover | ||
| WBC | 0.5% or less | 2.0% or less | |
| RBC | 0.5% or less | 2.0% or less | |
| HGB | 0.5% or less | 2.0% or less | |
| PLT | 1.0% or less | 2.0% or less | |
| 11 | Principles | ||
| WBC | Coulter method | Coulter method | |
| RBC | Coulter method | Coulter method | |
| PLT | Coulter method | Coulter method | |
| HGB | Colorimetric method | Hemoglobinometrymethod | |
| 12 | Analysis Vessels | Simultaneous analysis of RBC and WBC in separate analysis vessels, and using a single aperture each of WBC and RBC counting and sizing. | Simultaneous analysis of RBC and WBC in separate analysis vessels, and using a single aperture each of WBC and RBC counting and sizing. |
| 13 | Normal PatientRanges | Ability to set normal patient ranges against which sample results are compared. Sample results are flagged with "H" is the result is above the normal range and "L" if below the normal range. | Ability to set normal patient ranges against which sample results are compared. Sample results are flagged with "H" is the result is above the normal range and "L" if below the normal range. |
| 14 | Sample Processing | Utilizes an automatic sampling, diluting and mixing device for sample processing. | Utilizes an automatic sampling, diluting and mixing device for sample processing. |
| 15 | Quality Control | Provides 2 QC programs: L-J Analysis and X-B Analysis. | Provides QC programs: L-J Analysis. |
| 16 | Calibration | Provides 2 calibration programs: manual calibration and auto calibration using commercial calibrators. | Provides 2 calibration programs: manual calibration and auto calibration using commercial calibrators. |
| 17 | Aperture Alert | Minimize the possibility | Minimize the possibility |
| of reporting erroneousresults caused by apartial or transientaperture clog or by otheraperture disturbance. | of reporting erroneousresults caused by apartial or transientaperture clog or by otheraperture disturbance. | ||
| 18 | Software | This system is run bycomputer software.Ability to calculate data,store data and reviewresults. | This system is run bycomputer software.Ability to calculate data,store data and reviewresults. |
| 19 | RecommendedControls | BC-3D :Low, Normaland High | 4C PLUS cell control:abnormal low, normal,and abnormal high. |
| 20 | RecommendedCalibrator | SC-CAL PLUS | S-CAL calibrator |
| 21 | Sample VolumeAspirated | 13µL of whole blood20µL of predilute blood | 18µL of whole blood20µL of prediluted blood |
| 22 | Parameters | Parameters: WBC, RBC,HGB, HCT, MCV,MCH, MCHC, PLT,Lymph%, Lymph#,Mid%, Mid#, Gran%,Gran#, RDW, MPV | Parameters: WBC, RBC,Hgb, Hct, MCV, MCH,MCHC, Plt, LY%, LY#,MO%, MO#, GR%,GR#, RDW, MPV |
{13}------------------------------------------------
{14}------------------------------------------------
{15}------------------------------------------------
The BC-3200 Auto Hematology Analyzer is substantially equivalent to COULTER® AC.T diff 2TM Analyzer. The design, components, characteristic performance of the BC-3200 Auto Hematology Analyzer is similar to its predicate device. The system provides a means for count WBC, RBC, PLT and HGB for human in clinical laboratory.
The differences between the BC-3200 Auto Hematology Analyzer and COULTER® AC.T diff 2TM Analyzer are performance value, sample volume aspirated and operating mole. These differences do not affect the safety or efficacy of the device.
Testing:
Laboratory testing was conducted to validate and verify that the BC-3200 Auto Hematology Analyzer met all design specifications and was substantially equivalent to the predicate device. The testing was performed to demonstrate compliance with the hazard analysis of the system and its
{16}------------------------------------------------
software was performed and testing was conducted to validate the systems overall operation. The BC-3200 Auto Hematology Analyzer has also been tested to assure compliance to the requirements of various published standards, including IEC61010-1, IEC61010-2-101, ISO14971, EN 13640, EN 591, EN 375, EN 980 and IEC 61326.
Clinical testing was conducted to validate and verify that the BC-3200 Auto Hematology Analyzer met all design performance characteristic and was substantially equivalent to the predicate device. The testing consisted of all performance identified in the Guidance Document issued on December 4. 2001 "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".
Although the device is neither life supporting nor life sustaining, diagnostic information derived from the use of the device and alarms generated by the device may be critical to the proper management of the patient. So, the areas of risk for this device are the same as other devices in this class, the significant risk is misdiagnosis:
- Inadequate design of the signal processing and measurement circuitry or program can lead generation of inaccurate diagnostic data. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk unnecessarily.
- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Inadequate design of the device's software, used to make various measurements, can lead to generation of inaccurate diagnostic data. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk unnecessarily.
Conclusion:
The conclusions drawn from clinical and laboratory testing of the BC-3200 Auto Hematology Analyzer demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate device-COULTER® AC.T diff 2TM Analyzer.
{17}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/17/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three flowing ribbons below. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 1 2007
Susan D. Goldstein-Falk Shenzhen Mindray Bio-Medical Electronics Co., Ltd. c/o MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K063407
Trade/Device Name: BC-3200 Auto Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: May 31, 2007 Received: June 1, 2007
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
{18}------------------------------------------------
Page 2 - Susan D. Goldstein-Falk
will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Robert L. Becker, Jr., MD, PhD
Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page __ 1 of __ 1
510(k) Number (if known): K0603407
Device Name: BC-3200 Auto Hematology Analyzer
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.
OR
Prescription Use X
Over-The Counter Use
(Per 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
0041
. * :
510(k) K063407
§ 864.5220 Automated differential cell counter.
(a)
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.(b)
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.”