(214 days)
K#990352
K#990352
No
The summary describes a standard automated hematology analyzer using established methods (Coulter method, colorimetric method) and does not mention any AI or ML components in its operation, analysis, or flagging mechanisms.
No.
Explanation: The device is an analyzer that identifies normal patient parameters and flags results requiring further study, performing in vitro diagnostic measurements of blood parameters. It does not directly treat or diagnose diseases but rather provides data for diagnosis.
Yes
Explanation: The device is explicitly stated to be used for "In Vitro Diagnostic purpose" and "to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies," which are functions of a diagnostic device.
No
The device description explicitly states that the system consists of the analyzer, reagents, controls, calibrator, and accessories, indicating it is a hardware-based system with associated software, not a software-only device.
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 analyzer is "to be used in clinical laboratories for In Vitro Diagnostic purpose."
- Explicit Statement in Device Description: The device description also states that it is "for In Vitro Diagnostic Use in clinical laboratories."
- Nature of the Device: The device analyzes human blood samples in vitro (outside the body) to provide quantitative measurements of various blood parameters. This is the core function of an in vitro diagnostic device.
- Intended Use: The intended use is to identify normal patients and flag results requiring further study, which is a diagnostic function performed on biological samples.
- Care Setting and User: It is intended for use by trained medical professionals in clinical laboratories, a typical setting for IVD 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.
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Ability to flag abnormal WBC histograms: The test set included 200 samples. The data source was not explicitly stated, but the results were compared to those obtained by manual differential. The annotation protocol involved comparing the BC-3200's results to the manual differential.
Summary of Performance Studies
- Reproducibility (Replicate Testing):
- Study Type: Reproducibility testing.
- Sample Size: Not explicitly stated for total unique samples, but testing was performed with "samples of low, normal and high concentrations, three samples for each concentration." Each sample was tested 11 replicate times.
- Key Results: Reproducibility was determined by replicate testing (n = 11) using low, normal, and high concentrations, with results from the 2nd to 11th runs used to calculate Standard Deviation (SD) and Coefficient of Variation (CV%). CV% ranged from 0.8% to 8.39% for various parameters (WBC, RBC, HGB, MCV, PLT) across different concentration levels.
- Inter-Laboratory Precision:
- Study Type: Inter-laboratory precision study.
- Sample Size: Three samples of various concentrations (low, normal, high) were prepared, each with sufficient volume for two laboratories to run twice.
- Key Results: Repeatability variance ($S_r^2$), between laboratory variance ($S_L^2$), and reproducibility variance ($S_R^2$) were calculated for WBC, RBC, HGB, MCV, PLT, Lymph%, Mid% and Gran%. CV% for reproducibility ranged from 0.49% to 8.84% across different parameters and concentration levels.
- Linearity:
- Study Type: Linearity testing.
- Sample Size: Not explicitly stated but "diluted samples" were used. Dilution percentages ranged from 0% to 100%. Each concentration was tested twice.
- Key Results: Linear regression equations (slope and intercept) were determined for WBC, RBC, HGB, and PLT. Error and proportional error were calculated for each dilution.
- Carryover:
- Study Type: Carryover testing.
- Sample Size: High concentration sample (whole blood) and low concentration sample (whole blood); high level control and specified diluent. Each sample was run three consecutive times.
- Key Results: Carryover percentages were calculated. For whole blood, WBC was 0%, RBC 0.46%, HGB 0.46%, and PLT 0%. For high level control, all parameters (WBC, RBC, HGB, PLT) showed 0% carryover.
- Correlation to Predicate Device (Coulter A.T diff 2TM):
- Study Type: Correlation study.
- Sample Size: 103 samples for most parameters, 98 for differential parameters, and 102 for MPV.
- Key Results: Correlation coefficients (r) were strong for most parameters (e.g., WBC 0.9994, RBC 0.9971, HGB 0.9982, PLT 0.9961). Mid# and Mid% showed lower correlation coefficients (0.9187 and 0.4644, respectively).
- Correlation to Manual Differential:
- Study Type: Correlation study.
- Sample Size: 196 samples.
- Key Results: Correlation coefficients (r) were 0.95 for Lymph%, 0.57 for Mid%, and 0.94 for Gran%.
- Ability to Flag Abnormal WBC Histograms:
- Study Type: Evaluation of flagging ability.
- Sample Size: 200 samples.
- Key Results:
- Agreement (%): 82.5
- False Positive Ratio (%): 10.6
- False Negative Ratio (%): 45
(TP=22, FN=18, FP=17, TN=143, based on manual differential as reference)
- Reference Ranges Study:
- Study Type: Normal Ranges Study.
- Sample Size: 121 donors.
- Key Results: Established 90% Confidence Low and High Limits for various parameters (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW, MPV, Lymph%, Mid%, Gran%) based on the collected whole-blood samples.
Key Metrics
- Reproducibility (CV%):
- Low: WBC 1.63%, RBC 1.45%, HGB 0.8%, MCV 0.62%, PLT 3.12%
- Normal: WBC 0.99%, RBC 0.78%, HGB 0.8%, MCV 0.33%, PLT 1.95%
- High: WBC 1.03%, RBC 0.84%, HGB 0.8%, PLT 1.58%
- Inter-Laboratory Precision (Reproducibility CV%): 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%.
- Carryover (%): WBC 0%, RBC 0.46%, HGB 0.46%, PLT 0% (whole blood); WBC 0%, RBC 0%, HGB 0%, PLT 0% (high level control).
- Correlation Coefficients (r) to Predicate Device:
- WBC: 0.9994
- Lymph#: 0.9890
- Mid#: 0.9187
- Gran#: 0.9978
- Lymph%: 0.9751
- Mid%: 0.4644
- Gran%: 0.9707
- RBC: 0.9971
- HGB: 0.9982
- HCT: 0.9950
- MCV: 0.9824
- MCH: 0.9791
- MCHC: 0.6784
- RDW: 0.9569
- PLT: 0.9961
- MPV: 0.9334
- Correlation Coefficients (r) to Manual Differential:
- Lymph%: 0.95
- Mid%: 0.57
- Gran%: 0.94
- Ability to Flag Abnormal WBC Histograms:
- Agreement (%): 82.5
- False Positive Ratio (%): 10.6
- False Negative Ratio (%): 45
Predicate Device(s)
K#990352, COULTER® A . T diff 2TM Analyzer
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
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
1
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.
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 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
3
| 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
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 (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% |
5
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(%) | 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 |
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 | 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 |
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 | / |
| 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( $\times 10^3 / \mu L$ ) | 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 | | Difference
ratio
(D%) | Slope
(a) | Intercept
(b) | Correlation
coefficients |
|------------|---------------|---------|-------------------|-----------------------------|--------------|------------------|-----------------------------|
| | | BC-3200 | A o. T
diiff 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 |
11
| 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) | Correlation
coefficient
(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.
| 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
| 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 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;
M-30R RINSE;
M-30CFL LYSE;
M-30E
CLEANSER;
M-30P
CLEANSER | dff AC.T Park or diff AC.T Tain reagent park,
both of which contain
diluent and lytic reagent.
E-Z AC.T Rinse Shutdown
PROBE 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 /μL
3.0% or less | 6.0-15.0 $\times$ 103 /μL
3.0% or less |
| | RBC | 3.50-6.00 $\times$ 106 /μL
2.5% or less | 3.00-6.00 $\times$ 106 /μL
3.0% or less |
| | HGB | 11.0-18.0 g/dL
2.0% or less | 12.0-18.0 g/dL
2.0% or less |
| | MCV | 80.0-110.0 fL
2.0% or less | 80.0-100.0 fL
3.0% or less |
| | PLT | 200-400 $\times$ 103 /μL
6.0% or less | 200-500 $\times$ 103 /μL
7.0% 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 | 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
Ranges | 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 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 | Recommended
Calibrator | SC-CAL PLUS | S-CAL calibrator |
| 21 | Sample Volume
Aspirated | 13µL of whole blood
20µL of predilute blood | 18µL of whole blood
20µL 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
19
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