(160 days)
K#990352
Not Found
No
The summary describes a standard automated hematology analyzer using established methods (Coulter and colorimetric) and does not mention any AI/ML components or methodologies. The performance studies focus on traditional analytical validation metrics.
No
Explanation: The device is an in vitro diagnostic (IVD) hematology analyzer used to identify normal patient samples and flag those requiring further study. It provides diagnostic information but does not treat or prevent disease, which is the definition of a therapeutic device.
Yes
The device is an automated hematology analyzer used for In Vitro Diagnostic (IVD) purposes to analyze human blood parameters and identify patient results that require additional studies, which fits the definition of a diagnostic device.
No
The device description explicitly states that the BC-3200 Auto Hematology Analyzer system consists of the analyzer (hardware), reagents, controls, calibrator, and accessories, in addition to any software components. It also describes hardware-based measurement methods (Coulter method and colorimetric method).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use/Indications for Use: The document clearly states that the BC-3200 auto hematology analyzer is "to be used in clinical laboratories for In Vitro Diagnostic purpose."
- Explicit Statement in Device Description: The device description also explicitly states that it is "for In Vitro Diagnostic Use in clinical laboratories."
- Nature of the Device: The device analyzes human blood samples to provide quantitative measurements of various hematological parameters. This process of analyzing biological samples outside of the body to obtain diagnostic information is the core definition of an in vitro diagnostic device.
- Intended User and Setting: The intended users are "trained medical professionals in clinical laboratories," which is a typical setting for IVD use.
The document provides multiple clear and direct statements indicating that the BC-3200 is intended for in vitro diagnostic use.
N/A
Intended Use / 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.
Product codes
GKZ
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals / clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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%. See Table 1 to Table 3.
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.
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.
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)]×100%. The test was then repeated using the high level control. See Table 9 and Table 10.
Correlation is determined by comparing the results (both CBC and DIFF) obtained by the BC-3200 to those by the Coulter A.T diff 2 TM and by comparing the DIFF results obtained by the BC-3200 to those by manual differential. See Table 11 and Table 12.
Ability to flag abnormal WBC histograms was determined by comparing 200 sample results obtained by the BC-3200 to those obtained by manual differential. See Table 13.
A Normal Ranges Study was conducted to assess the Reference Ranges for the BC-3200 analyzer. Whole-blood samples were collected from 121 donors.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Reproducibility: Sample size: n=11 for each low, normal, and high concentration samples. Result: SD and CV% values reported for WBC, RBC, HGB, MCV, PLT at low, normal, and high concentrations (Table 1, 2, 3).
Inter-Laboratory Precision: Sample size: 3 samples (low, normal, high concentration), run twice on each of two BC-3200 analyzers. Results: Repeatability variance, Between Laboratory variance, Reproducibility variance, SR, and CV% calculated for WBC, Gran%, Lymph%, Mid%, RBC, HGB, MCV, PLT at low, normal, and high concentrations (Table 4).
Linearity: Tested concentrations from 0% to 100% (diluted samples), each concentration twice. Results: Mean, Ideal, Error, and Proportional error reported for WBC (Table 5), RBC (Table 6), HGB (Table 7), and PLT (Table 8). Slope and Intercept values also provided.
Carryover: Determined by running high and low concentration samples three times each (whole blood and high level control). Results: Carryover percentage calculated for WBC, RBC, HGB, PLT (Table 9, 10). All carryover values were 0% or very low (0.46% for RBC and HGB in Table 9).
Correlation:
* BC-3200 vs. Coulter A.T diff 2™: Sample size: 103 for CBC parameters (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV) and 98 for differential parameters (Gran%, Mid%, Lymph%, Gran#, Mid#, Lymph#). Results: Mean, Difference ratio (D%), Slope (a), Intercept (b), and Correlation coefficients (Table 11). Correlation coefficients were generally high, e.g., 0.9990 for WBC, 0.9955 for RBC, 0.9972 for HGB, 0.9943 for PLT. Lower for Mid% (0.3926).
* BC-3200 vs. manual differential: Sample size: 196. Results: Mean, Slope (a), Intercept (b), and Correlation coefficient (r) for Lymph%, Mid%, Gran% (Table 12). Correlation coefficients were 0.95 for Lymph%, 0.57 for Mid%, 0.94 for Gran%.
Ability to flag abnormal WBC histograms: Sample size: 200. Results: True positive (22), False Negative (18), False Positive (17), True Negative (143). Agreement (82.5%), False Positive Ratio (10.6%), False Negative Ratio (45%) (Table 13).
Reference Ranges (Normal Population Study): Sample size: 121 donors. Results: Mean, 90% Confidence Low Limit, and 90% Confidence High Limit for WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW, MPV, Lymph%, Mid%, Gran% (Table 14).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Ability to flag abnormal WBC histograms (Table 13):
- Agreement (%): 82.5
- False Positive Ratio (%): 10.6
- False Negative Ratio (%): 45
Predicate Device(s)
K#990352, COULTER® AC-T diff 2TM Analyzer, Coulter Corporation.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
APR - 8 2010
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.
The assigned 510(k) number is: 5093394
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, 2009
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
1
Legally Marketed Predicate Device:
K#990352, COULTER® AC-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.
2
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 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.
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 | (×103 / μL) | (×106 /μL) | (g/dL) | (fl) | (×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 | (×103 / μL) | (×106 /μL) | (g/dL) | (fl) | (×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 | (×103 / μL) | (×106 /μL) | (g/dL) | (fl) | (×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 |
Table 1 Imprecision , low concentration samples
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| WBC | RBC | HGB | MCV | PLT | |
|---|---|---|---|---|---|
| 1 | (×10³/μL) | (×10⁶/μL) | (g/dL) | (fl) | (×10³/μL) |
| mean | 10.1 | 4.60 | 13.1 | 83.3 | |
| SD | 0.12 | 0.03 | 0.09 | 0.38 | |
| CV(%) | 1.18 | 0.73 | 0.7 | 0.45 | 3.30 |
| 2 | WBC | RBC | HGB | MCV | PLT |
| (×10³/μL) | (×10⁶/μL) | (g/dL) | (fl) | (×10³/μL) | |
| mean | 9.8 | 5.34 | 15.2 | 83.1 | |
| SD | 0.10 | 0.04 | 0.12 | 0.27 | 4.86 |
| CV(%) | 0.99 | 0.78 | 0.8 | 0.33 | 1.95 |
| 3 | WBC | RBC | HGB | MCV | PLT |
| (×10³/μL) | (×10⁶/μL) | (g/dL) | (fl) | (×10³/μL) | |
| mean | 11.3 | 5.27 | 15.0 | 85.9 | |
| 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
| 1 | WBC
(×10³/μL) | RBC
(×10⁶/μL) | HGB
(g/dL) | MCV
(fl) | PLT
(×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
(×10³/μL) | RBC
(×10⁶/μL) | HGB
(g/dL) | MCV
(fl) | PLT
(×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
(×10³/μL) | RBC
(×10⁶/μL) | HGB
(g/dL) | MCV
(fl) | PLT
(×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
4
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 (8), between laboratory variance ( ( ), and reproducibility variance ( ( ) 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 (×106/μL) | ||||
| 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) | ||||
| Mean | 77.28 | 86.73 | 96.33 | |
| 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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6
:
.
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(%) | Laboratory | Form A | Form B | Form C | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
7
| 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 | 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 |
| 1 | 6.3 | 13.9 | 19 | ||||||
| 2 | 6.4 | 14.3 | 19.4 | 6.4 | 14.25 | 19.35 | 0 | 0.07 | 0.07 |
| 2 | 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 |
| 88 | 265 | 466 | 91.5 | 264.5 | 462.5 | 4.95 | 0.71 | 4.95 | |
| તેર | 264 | 459 | |||||||
| 97 | 248 | 474 | 98 | 252 | 474.5 | 1.41 | રું રહ્યું રેણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં છે. આ ગામનાં છે. આ ગામનાં છે. આ ગામનાં છે. આ ગામનાં છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂર | 0.71 | |
| 99 | 256 | 475 |
8
· 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 | 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 5 WBC 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 | | | | | |
9
Intercept
0.0191
| 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 6 RBC Linearity
Table 7 HGB 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 | | | | | |
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(×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 9 Carryover, high concentration sample
| 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% |
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 A .T diff 2 TM 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 | | Difference
ratio
(D%) | Slope
(a) | Intercept
(b) | Correlation
coefficients |
|------------|---------------|---------|-------------------------------|-----------------------------|--------------|------------------|-----------------------------|
| | | BC-3200 | A c. T
diiff 2 | | | | |
| WBC | 103 | 10.3 | 10.3 | 3.0 | 1.0091 | -0.0386 | 0.9990 |
| Gran% | 98 | 65.4 | 64.1 | 4.0 | 0.9046 | 7.3470 | 0.9581 |
| Mid% | 98 | 8.6 | 6.5 | 46.3 | 0.7569 | 3.8798 | 0.3926 |
| Lymph% | 98 | 26.0 | 29.4 | 10.9 | 0.7935 | 2.5772 | 0.9709 |
| Gran# | 98 | 6.1 | 6.0 | 4.5 | 0.9886 | 0.1460 | 0.9961 |
| Mid# | 98 | 0.7 | 0.5 | 42.6 | 2.1022 | -0.3798 | 0.8701 |
MINDRAY PROPRIETARY
11
| Lymph# | 98 | 1.9 | 2.1 | 11.1 | 0.9918 | -0.1864 | 0.9886 |
|---|---|---|---|---|---|---|---|
| RBC | 103 | 4.31 | 4.27 | 2.0 | 0.9910 | 0.0767 | 0.9955 |
| HGB | 103 | 12.5 | 12.5 | 1.5 | 0.9939 | 0.0981 | 0.9972 |
| HCT | 103 | 37.6 | 37.2 | 2.7 | 1.0014 | 0.4334 | 0.9923 |
| MCV | 103 | 87.8 | 87.5 | 1.3 | 0.9492 | 4.8276 | 0.9778 |
| MCH | 103 | 29.2 | 29.5 | 1.8 | 0.9377 | 1.5489 | 0.9712 |
| MCHC | 103 | 33.3 | 33.7 | 2.2 | 0.7497 | 8.0314 | 0.6038 |
| RDW | 103 | 13.1 | 13.5 | 5.3 | 0.4295 | 7.3191 | 0.9387 |
| PLT | 103 | 228 | 230 | 10.0 | 0.8859 | 24.193 | 0.9943 |
| MPV | 103 | 8.4 | 8.8 | 4.9 | 0.7037 | 2.2287 | 0.9169 |
Table 11 Correlation to Coulter A .T diff 2™
| Parameter | Samples
(n) | Mean | | Slope
(a) | Intercept
(b) | 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 |
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.
| 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 |
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.
12
| 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 | % | 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 |
| 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® AC-T diff 2TM Analyzer
| NO | Feature | BC-3200 Auto
Hematology Analyzer | COULTER® AC·T diff
2TM Analyzer |
|----|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | 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. | The COULTER® AC·T
diff 2TM Analyzer is a
quantitative, automated
hematology analyzer
and leukocyte
differential counter For
In Vitro Diagnostic Use
in clinical laboratories. |
| 2 | Sample Types | Whole Blood Mode and
Prediluted Mode | Whole blood mode
and Prediluted mode |
| 3 | Operating Modes | Closed Vial Whole
Blood mode | Open Vial Whole Blood
mode and Closed Vial
Whole Blood mode |
| 4 | Throughput | 1 minute / analysis | 60 seconds or less |
| 5 | Reagents Required | M-30D DILUENT; | dff AC.T Park or diff |
| | | M-30R RINSE; | AC.T Tain reagent park, |
| | | M-30CFL LYSE; | both of which contain |
| | | M-30E E-Z | diluent and lytic reagent.
AC.T Rinse Shutdown |
| | | CLEANSER; | Diluent |
| | | M-30P PROBE | |
| | | CLEANSER | |
| 6 | Operating Range | | |
| | WBC | 0.0 - 299.9 (×103/μL) | 0.0-150 (×103/μL) |
| | RBC | 0.00 - 19.99 (×106/μL) | 0.00-8.00 (×106/μL) |
| | HGB | 0-29.9 (×g/dL) | 0.00-30.0 (×g/dL) |
| | PLT | 0 - 2999 (×103/μL) | 000-3000 (×103/μL) |
| | MCV | 0.0 - 249.9fL | 50.0-130.0 fL |
| 7 | Background Counts | | |
| | WBC | 0.3×103 /μL or less | 0.4×103 /μL or less |
| | RBC | 0.03×106 /μL or less | 0.04×106 /μL or less |
| | HGB | 0.1 g/dL or less | 0.2 g/dL or less |
| | PLT | 10 × 103 /μL or less | 7.0×103 /μL or less |
| 8 | Reproducibility | | |
| | WBC | 7.0-15.0×103 /μL | 6.0-15.0×103 /μL |
| | | 3.0% or less | 3.0% or less |
| | RBC | 3.50-6.00×106 /μL | 3.00-6.00×106 /μL |
| | | 2.5% or less | 3.0% or less |
| | HGB | 11.0-18.0 g/dL | 12.0-18.0 g/dL |
| | | 2.0% or less | 2.0% or less |
| | MCV | 80.0-110.0 fL | 80.0-100.0 fL |
| | | 2.0% or less | 3.0% or less |
| | PLT | 200-400×103 /μL | 200-500×103 /μL |
| | | 6.0% or less | 7.0% or less |
| 9 | Linearity | | |
| | WBC | 0.3-99.9 (×103/μL) | 0 - 99.9(×103/μL) |
| | | ±0.3 or ±5% | ±0.3 or ±5% |
| | RBC | 0.20 -7.99(×106/μL) | 0-7.0(×106/μL) |
| | | ±0.05 or ±5% | ±0.05 or ±5.0% |
| | HGB | 1.0-24.9 (g/dL) | 0 - 25.0 (g/dL) □ |
| | | ±0.2 or ±3% | ±0.2 or ±3.0% |
| | PLT | 10-999(×103/μL) | 0 - 999 (×103/μL) □ |
| | | ±10 or ±10% | ±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 | Hemoglobinometry
method |
| 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 Patient | 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. |
| | | of reporting erroneous
results caused by a
partial or transient
aperture clog or by other
aperture disturbance. | of reporting erroneous
results caused by a
partial or transient
aperture clog or by other
aperture disturbance. |
| 18 | Software | This system is run by
computer software.
Ability to calculate data,
store data and review
results. | This system is run by
computer software.
Ability to calculate data,
store data and review
results. |
| 19 | Recommended
Controls | BC-3D :Low, Normal
and High | 4C PLUS cell control:
abnormal low, normal,
and abnormal high. |
| 20 | Listing parameters for
Controls | Parameters: WBC, RBC,
HGB, HCT, MCV,
MCH, MCHC, PLT,
Lymph%, Lymph#,
RDW, MPV, Mid%,
Mid#, Gran%, Gran# | Parameters: WBC, RBC,
Hgb, Hct, MCV, MCH,
MCHC, Plt, LY%, LY#,
RDW, MPV, MO%,
MO#, GR%, GR# |
| 21 | Recommended
Calibrator | SC-CAL PLUS | S-CAL calibrator |
| 22 | Sample Volume
Aspirated | 13µL of whole blood
20µL of predilute blood | 18µL of whole blood
20µL of prediluted blood |
| 23 | 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
MINDRAY®PROPRIETARY
14
.. .
15
The BC-3200 Auto Hematology Analyzer is substantially equivalent to COULTER® ACT 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.
16
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 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.
17
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® Aº.T diff 2™
18
Image /page/18/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. c/o Ms. Susan D. Goldstein-Falk Official Correspondent for Shenzhen Mindray Bio-Medical Electronics Co., Ltd MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K093394
.. .
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: April 5, 2010 Received: April 7, 2010
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
APR 0 8 2010
19
Page 2 - Ms. Susan D. Goldstein-Falk
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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
inana in char
Maria M. Chan. Ph.D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
20
Page _ 1 __of_1
510(k) Number (if known): K093394
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.
Prescription Use X
Over-The Counter Use
(Per 21 CFR 801 Subpart D)
OR (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)
i m. Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093394
32