BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C
Device Facts
| Record ID | K093394 |
|---|---|
| Device Name | BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| Product Code | GKZ · Hematology |
| Decision Date | Apr 8, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5220 |
| Device Class | Class 2 |
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.
Device Story
The BC-3200 is an automated hematology analyzer for clinical laboratory use by trained professionals. It processes whole blood samples (closed vial or prediluted) using automated sampling, diluting, and mixing. It employs two measurement methods: the Coulter method for WBC, RBC, and PLT counting/sizing, and a colorimetric method for HGB concentration. The system generates 16 hematology parameters and three histograms. Results are compared against user-defined normal ranges; the device flags abnormal results (H/L) for further clinical review. This automated analysis assists clinicians in patient screening and identifying samples requiring manual differential or additional diagnostic studies.
Clinical Evidence
No new clinical data was required for this submission. Analytical performance (accuracy, precision, linearity, carryover) was established under the previous clearance (k063407). The current submission focuses on software modifications to unmask four parameters (Mid%, Mid#, RDW, MPV) for QC reporting, supported by software validation and hazard analysis documentation.
Technological Characteristics
Automated hematology analyzer; Coulter impedance principle for WBC, RBC, PLT; colorimetric method for HGB. Dimensions/form factor: benchtop. Connectivity: computer-controlled with data storage/review. Reagents: M-30 series (diluent, rinse, lyse, cleansers). Standards: IEC61010-1, IEC61010-2-101, ISO14971, EN 13640, EN 591, EN 375, EN 980, IEC 61326.
Indications for Use
Indicated for use in clinical laboratories by trained medical professionals to perform quantitative automated hematology analysis and leukocyte differential counting on human blood samples to identify normal patients and flag results requiring further study.
Regulatory Classification
Identification
An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”
Predicate Devices
- COULTER® A⁶•T diff 2™ Analyzer (k990352)
Related Devices
- K063407 — BC-3200 AUTO HEMATOLOGY ANALYZER · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 11, 2007
- K143348 — BC-3600 Auto Hematology Analyzer · Mindray Bio-Medical Electronics Co., Ltd. · Aug 21, 2015
Submission Summary (Full Text)
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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
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# 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.
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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 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<br>(×10³/μL) | RBC<br>(×10⁶/μL) | HGB<br>(g/dL) | MCV<br>(fl) | PLT<br>(×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<br>(×10³/μL) | RBC<br>(×10⁶/μL) | HGB<br>(g/dL) | MCV<br>(fl) | PLT<br>(×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<br>(×10³/μL) | RBC<br>(×10⁶/μL) | HGB<br>(g/dL) | MCV<br>(fl) | PLT<br>(×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 (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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:
.
# 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 |
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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 | 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 | | | | | | |
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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 | Proportional<br>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<br>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 | | | | | |
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Intercept
### 0.0191
| Dilution (%) | Test 1 | Test 2 | Mean | Ideal | Error | Proportional<br>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<br>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
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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<br>sample (whole blood) | | | Low concentration<br>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<br>sample (high level<br>control) | | | Low concentration<br>sample (specified<br>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<br>(n) | Mean | | Difference<br>ratio<br>(D%) | Slope<br>(a) | Intercept<br>(b) | Correlation<br>coefficients |
|------------|---------------|---------|-------------------------------|-----------------------------|--------------|------------------|-----------------------------|
| | | BC-3200 | A c. T<br>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
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| 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<br>(n) | Mean | | Slope<br>(a) | Intercept<br>(b) | Correlation<br>coefficient<br>(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<br>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.
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| Parameter | Units | Sex | Mean | 90%Confidence<br>Low Limit | 90%Confidence<br>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<br>Hematology Analyzer | COULTER® AC·T diff<br>2TM Analyzer |
|----|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | The BC-3200 auto<br>hematology analyzer is a<br>quantitative, automated<br>hematology analyzer and<br>leukocyte differential<br>counter for In Vitro<br>Diagnostic Use in<br>clinical laboratories. | The COULTER® AC·T<br>diff 2TM Analyzer is a<br>quantitative, automated<br>hematology analyzer<br>and leukocyte<br>differential counter For<br>In Vitro Diagnostic Use<br>in clinical laboratories. |
| 2 | Sample Types | Whole Blood Mode and<br>Prediluted Mode | Whole blood mode<br>and Prediluted mode |
| 3 | Operating Modes | Closed Vial Whole<br>Blood mode | Open Vial Whole Blood<br>mode and Closed Vial<br>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.<br>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<br>method |
| 12 | Analysis Vessels | Simultaneous analysis of<br>RBC and WBC in<br>separate analysis vessels,<br>and using a single<br>aperture each of WBC<br>and RBC counting and<br>sizing. | Simultaneous analysis of<br>RBC and WBC in<br>separate analysis<br>vessels, and using a<br>single aperture each of<br>WBC and RBC counting<br>and sizing. |
| 13 | Normal Patient | Ability to set normal<br>patient ranges against<br>which sample results are<br>compared. Sample<br>results are flagged with<br>"H" is the result is above<br>the normal range and<br>"L" if below the normal<br>range. | Ability to set normal<br>patient ranges against<br>which sample results are<br>compared. Sample<br>results are flagged with<br>"H" is the result is above<br>the normal range and<br>"L" if below the normal<br>range. |
| 14 | Sample Processing | Utilizes an automatic<br>sampling, diluting and<br>mixing device for sample<br>processing. | Utilizes an automatic<br>sampling, diluting and<br>mixing device for<br>sample processing. |
| 15 | Quality Control | Provides 2 QC programs:<br>L-J Analysis and X-B<br>Analysis. | Provides QC programs:<br>L-J Analysis. |
| 16 | Calibration | Provides 2 calibration<br>programs: manual<br>calibration and auto<br>calibration using<br>commercial calibrators. | Provides 2 calibration<br>programs: manual<br>calibration and auto<br>calibration using<br>commercial calibrators. |
| | | of reporting erroneous<br>results caused by a<br>partial or transient<br>aperture clog or by other<br>aperture disturbance. | of reporting erroneous<br>results caused by a<br>partial or transient<br>aperture clog or by other<br>aperture disturbance. |
| 18 | Software | This system is run by<br>computer software.<br>Ability to calculate data,<br>store data and review<br>results. | This system is run by<br>computer software.<br>Ability to calculate data,<br>store data and review<br>results. |
| 19 | Recommended<br>Controls | BC-3D :Low, Normal<br>and High | 4C PLUS cell control:<br>abnormal low, normal,<br>and abnormal high. |
| 20 | Listing parameters for<br>Controls | Parameters: WBC, RBC,<br>HGB, HCT, MCV,<br>MCH, MCHC, PLT,<br>Lymph%, Lymph#,<br>RDW, MPV, Mid%,<br>Mid#, Gran%, Gran# | Parameters: WBC, RBC,<br>Hgb, Hct, MCV, MCH,<br>MCHC, Plt, LY%, LY#,<br>RDW, MPV, MO%,<br>MO#, GR%, GR# |
| 21 | Recommended<br>Calibrator | SC-CAL PLUS | S-CAL calibrator |
| 22 | Sample Volume<br>Aspirated | 13µL of whole blood<br>20µL of predilute blood | 18µL of whole blood<br>20µL of prediluted blood |
| 23 | Parameters | Parameters: WBC, RBC,<br>HGB, HCT, MCV,<br>MCH, MCHC, PLT,<br>Lymph%, Lymph#,<br>Mid%, Mid#, Gran%,<br>Gran#, RDW, MPV | Parameters: WBC, RBC,<br>Hgb, Hct, MCV, MCH,<br>MCHC, Plt, LY%, LY#,<br>MO%, MO#, GR%,<br>GR#, RDW, MPV |
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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
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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
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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
