(273 days)
I am sorry, but the input "Not Found" does not contain any information about Predicate Device(s) K/DEN numbers. Therefore, I cannot identify or list them.
Not Found
No
The summary describes a standard automated hematology analyzer that performs quantitative measurements and provides histograms. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the context of medical devices. The performance studies focus on traditional analytical validation metrics like method comparison, precision, linearity, etc.
No.
Explanation: The device is an in vitro diagnostic hematology analyzer used to quantify blood cell parameters. Its purpose is to identify normal human patients from those requiring additional studies, not to treat any condition.
Yes
The device is explicitly stated as an "auto hematology analyzer for in vitro diagnostic use in clinical laboratories" and its purpose is to "identify the normal human patient... from patients whose results require additional studies." This indicates its role in diagnosing or assessing health conditions based on blood parameters.
No
The device description explicitly states that the system consists of an analyzer (BC-3600), reagents, controls, and a calibrator, indicating it is a hardware-based system with associated consumables, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The very first sentence of the "Intended Use / Indications for Use" section clearly states: "The BC-3600 auto hematology analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in clinical laboratories."
- Explicit Statement in Device Description: The "Device Description" section also reiterates this: "The BC-3600Auto Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for In Vitro Diagnostic Use in clinical laboratories."
- Analysis of Biological Specimens: The device analyzes "whole blood specimens" which are biological samples taken from the human body.
- Clinical Laboratory Setting: The intended use specifies that it is for use "in clinical laboratories."
- Purpose of Diagnosis/Identification: The purpose is to "identify the normal human patient... from patients whose results require additional studies," which is a diagnostic function.
- Measurement of Clinical Parameters: The device measures various blood parameters (WBC, RBC, HGB, etc.) that are used in the diagnosis and monitoring of various medical conditions.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the compatibility of tissues or organs, or to monitor therapeutic measures.
N/A
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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2015
Mindray Bio-medical Electronics Co., LTD c/o Jinjie Hu, Ph.D. Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington Street. Suite 100 Alexandria, VA 22314
Re: K143348
Trade/Device Name: BC-3600 Auto Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: August 10, 2015 Received: August 14, 2015
Dear Dr. Hu:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
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Page 2 - Dr. Jinjie Hu
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Leonthena R. Carrington -S
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name BC-3600 Auto Hematology Analyzer
Indications for Use (Describe)
The BC-3600 auto hematology analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in clinical laboratories. The BC-3600 auto hematology analyzer provide complete blood count (WBC, RBC, HCT, MCV, MCH, MCHC, RDW, PLT, MPV) and leukocyte 3-Part differential (Lymph#, Mid%, Gran%) for whole blood specimens, collected in a salt of EDTA [dipotassium (K3)] obtained by venipuncture or fingerstick. The purpose of the BC-3600 Auto Hematology Analyzer is to identify the normal human patient, with normal system-generated parameters, from patients whose results require additional studies.
X Prescription Use (Part 21 CFR 801 Subpart D)
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Mindray Bio-medical electronics co., LTD
BC-3600 Auto Hematology Analyzer
510(k) Premarket Notification
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1. 510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the BC-3600 Auto Hematology Analyzer is provided below.
| Device Common Name: | Auto Hematology Analyzer |
|---|---|
| Device Proprietary Name: | BC-3600 Auto Hematology Analyzer |
| Submitter: | Mindray Bio-medical electronics co., LTD |
| Mindray Building, Keji 12th Road South, High-tech | |
| Industrial Park, Nanshan, | |
| Shenzhen, Guangdong 518057, P.R. China | |
| Contact: | Jinjie Hu Ph.D. |
| 400 N. Washington Street | |
| Suite 100 | |
| Alexandria, VA 22314 | |
| Tel: 301-814-4985 | |
| Email: jhu@bcg-usa.com | |
| Date Prepared: | November 14, 2014 |
| Classification Regulation: | 21 CFR 864.5220, Class II |
| Panel: | Hematology |
| Product Code: | GKZ |
Predicate Device:
BC-3200 Hematology Analyzer (K093394) BC-3200 AUTO HEMATOLOGY ANALYZER, M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E E-Z CLEANSER, M-30P PROBE CLEANSER, BC-3D, SC-CAL PLUS. SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Indication for Use:
The BC-3600 auto hematology analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in clinical laboratories. The BC-3600 auto hematology analyzer provide complete blood count (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV) and leukocyte 3-Part differential (Lymph#, Mid#, Gran#, Lymph%, Mid%, Gran%) for whole blood specimens, collected in a salt of EDTA [dipotassium (K2) or tripotassium (K3)] obtained by venipuncture or fingerstick. The purpose of the BC-3600 Auto Hematology Analyzer is to identify the normal human patient, with normal system-generated parameters, from patients whose results require additional studies.
Device Description
The BC-3600Auto 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
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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 of human blood and three histograms.
The BC-3600 Auto Hematology Analyzer system consists of:
- The analyzer (BC-3600) ●
- . Reagents
- M-30D DILUENT ।
- M-30CFL LYSE -
- M-30R RINSE
- PROBE CLEANSER
- . Controls
- BC-3D Control (High, Normal, Low levels)
- . Calibrator
- SC-CAL PLUS Calibrator
The analyzer provides analysis results of 16 parameters (listed below) of human blood and three histograms. The following list provides the abbreviations for all measurands:
| 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 |
| Hematocrit | HCT |
| Mean Corpuscular (erythrocyte) Volume | MCV |
| Mean Cell (erythrocyte) Hemoglobin | MCH |
| Mean Cell (erythrocyte) Hemoglobin Concentration | MCHC |
| Red Blood Cell (erythrocyte) Distribution Width | RDW |
| Platelet | PLT |
| Mean Platelet Volume | MPV |
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White Blood Cell Histogram Red Blood Cell Histogram Platelet Histogram
WBC Histogram RBC Histogram PLT Histogram
Principle of Operation
WBCs are counted and sized by the impedance method. This method is based on the measurement of changes in electrical resistance produced by a particle, which in this case is a blood cell suspended in a conductive diluent as it passes through an aperture of known dimensions. HGB is determined by the colorimetric method. RBCs and PLTs are counted by the impedance method also. In addition, volumetric metering is used. An accurate cell count cannot be obtained unless the precise volume of diluted sample that passes through the aperture during the count cycle is known. The analyzer uses a volumetric metering unit to control the count cycle and to ensure that a precise volume of sample is analyzed for the measurement.
Modes of Operation
The BC-3600 operates in a closed vial
Specimen identification
Specimen identification input is manual (by operator) or by barcode reader (optional).
Specimen sampling and handling
Samples are manually mixed and loaded into a sample compartment one at a time. The BC-3600 processes anti-coagulated whole blood collected in a K2EDTA or K3EDTA on two testing modes: whole blood analysis mode and predilute analysis mode.
Reagents. Calibrators and Controls
Reagents:
- . M-30D DILUENT
- M-30R RINSE
- M-30CFL LYSE ●
- PROBE CLEANSER .
Controls: BC-3D
Three levels of Controls with low, normal and high levels are provided. These Controls are exactly same as the Controls cleared in the predicate device BC-3200 analyzer. It is recommended to perform the quality control check using these controls at intervals established by the laboratory procedures and local or national regulations.
Calibrators: SC-CAL PLUS
Calibration and verification of Calibration are performed with the previously cleared Calibrator SC-CAL PLUS in the predicate device BC-3200 analyzer. The calibration and
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quality control should be performed according to the instruction for the Calibrator and to laboratory procedures and local or national regulations.
Software
The software is used to operate the system which features sample management, sample processing, data acquisition, data processing, result management, patient data management, and instrument management. The system is comprised of the BC-3600 analyzer with touch screen.
The BC-3600 Auto Hematology Analyzer contains moderate risk level software which has been fully verified and validated and documentation in accordance with FDA Guidance "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices: May 11, 2005" has been provided in this submission.
| FDA
Guidance | 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 | 2001 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| H26-A2 | Validation, Verification, and Quality Assurance of Automated
Hematology Analyzers; Proposed Standard - Second Edition | 2010 |
| EP6-A | Evaluation of the Linearity of Quantitative Measurement
Procedures: A Statistical Approach; Approved Guideline | 2003 |
| H20-A2 | Reference Leukocyte (WBC) Differential Count (Proportional) and
Evaluation of Instrumental Methods; Approved Standard - Second
Edition | 2007 |
| EP09-A3 | Measurement Procedure Comparison and Bias Estimation Using
Patient Samples; Approved Guideline - Third Edition | 2014 |
| EP17-A | Protocols for Determination of Limits of Detection and Limits of
Quantitation; Approved Guideline | 2009 |
| EP5-A2 | Evaluation of Precision Performance of Quantitative Measurement
Methods; Approved Guideline-Second Edition | 2005 |
| C28-A3 | Defining, Establishing, and Verifying Reference Intervals in the
Clinical Laboratory; Approved Guideline- Third Edition | 2008 |
Special Control and Guidance Document Referenced
Performance Characteristics
Method comparison
A total of 1222 K2EDTA whole blood samples were studied at three actual user sites, two in China and one in the US. Patients participated the study with age range from 1 day after birth to 100 years old, and with 547 females, 672 males and 3 samples with unknown age and gender. Patient's samples covered the normal and most abnormal
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conditions for all parameters. For each whole blood sample, three manual wedge smears were prepared and stained with Wright-Giemsa stain. A 400 cell WBC differential was performed on two smears per CLSI H20-A2. All samples were testing on whole blood mode in parallel with BC-3600 analyzer and the predicate device. An estimation of the bias was determined for each parameter according to EP09-A3. The result demonstrated the BC-3600 analyzer met the pre-defined specification of the difference limits. Whole blood accuracy and regression vs predicate and the flagging ability of BC-3600 vs Manual differential comparison was performed. Table 1 shows that the combined results from three (3) sites are comparable to the predicate device.
| Parameters | Result Range | r | slope
(95%CI) | intercept
(95%CI) | Mean | |
|----------------------|---------------|-------|---------------------------|-------------------------------|-----------|--------|
| | | | | | Predicate | Test |
| WBC
(x 10³/uL) | 0.15 to 103.1 | 0.999 | 0.990
(0.988 to 0.992) | 0.1861
(0.152 to 0.22) | 11.29 | 11.36 |
| Lymph#
(x 10³/uL) | 0.1 ~ 12.45 | 0.985 | 1.0665
(1.0571.076) | -0.155-0.134) | 2.16 | 2.15 |
(-0.176
| Mid#
(x 10³/uL) | 0.052.75 | 0.873 | 1.1011.237) | -0.06537
(0.964
(-0.12974~-0.001) | 0.60 | 0.60 |
| Gran#
(x 10³/uL) | 0.1 ~ 47.65 | 0.998 | 1.0674
(1.0641.071) | -0.2177-0.193) | 5.96 | 6.15 |
(-0.242
| Lymph%
(%) | 3.5569.3 | 0.982 | 1.0981.108) | -3.2854
(1.088
(-3.615~-2.956) | 30.67 | 30.39 |
| Mid%
(%) | 2.25 ~ 14.85 | 0.677 | 0.577
(0.5440.610) | 3.29763.564) | 8.28 | 8.07 |
(3.031
| Gran%
(%) | 23 ~ 92.95 | 0.985 | 1.0462
(1.0371.055) | -1.95427.57 | 0.997 | 1.0098
(-2.524 ~ - 1.385) | 62.48 | 63.41 |
| RBC
(x 10⁶/uL) | 1.04
(1.0071.013) | -0.02961.008) | -0.1434
(-0.043 ~ -0.016) | 4.25 | 4.26 |
| HGB
(g/dL) | 3.05 ~ 24.55 | 0.998 | 1.0055
(1.003
(-0.178 ~ -0.109) | 12.45 | 12.37 |
| HCT
(%) | 9.673.75 | 0.997 | 0.98290.986) | 0.8568
(0.98
(0.7320.982) | 38.03 | 38.23 |124 | 0.994 | 1.0132
| MCV
(fL) | 50.7
(1.0091.018) | -0.875-0.48) | 90.46 | 90.77 |
(-1.27
| MCH
(pg) | 15.3 ~ 44.25 | 0.991 | 1.0087
(1.0031.014) | -0.4767 -0.312) | 29.58 | 29.36 |
(-0.641
| MCHC
(d/fL) | 25.1547.65 | 0.915 | 0.9430.959) | 1.4625
(0.926
(0.9222.003) | 32.69 | 32.28 |1.1892) | -2.4167
| RDW
(%) | 11 ~ 20.7 | 0.901 | 1.1667
(1.1395
(-2.7514~-2.0523) | 14.28 | 14.23 |
| PLT
(x 10³/uL) | 12951.5 | 0.992 | 0.98470.99) | 7.0335
(0.979
(5.453~8.614) | 260.56 | 263.61 |
The Correlation and Estimated Bias of BC-3600 (Combined) (vs BC-Table 1: 3200)
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| Parameters | Result Range | ﻟﻘ | slope
(95%CI) | intercept
(95%CI) | Mean | |
|-------------|--------------|-------|------------------------|-------------------------|-----------|------|
| | | | | | Predicate | Test |
| MPV
(fL) | 6.3 ~ 11.8 | 0.865 | 0.793
(0.7730.813) | 1.62001.788) | 8.48 | 8.34 |
(1.452
The WBC flagging rate for the BC-3600 was compared to the WBC manual differential for the same population of samples as shown in Table 2.
Table 2: The WBC Flagging Ability of BC-3600 (Combined) (vs Manual)
| BC-3600 | |
|---|---|
| True Positive | 178 |
| True Negative | 739 |
| False Positive | 227 |
| False Negative | 64 |
| Total | 1208 |
| Sensitivity (TP %) | 73.6% |
| Specificity (TN %) | 76.5% |
| Efficiency | 75.9% |
Precision/Reproducibility
Reproducibility study was performed on BC-3600 to evaluate the long term imprecision of the device using three level of control material (BC-3D control Low, Normal and High) for complete blood counts and leukocyte 3 Part Differential parameters. Each level control samples were run in duplicated twice each day for 20 days on the BC-3600 analyzer at each of the three clinical sites. Data were analyzed for each site and for the combined data from all sites used the same lot control according to the guidance provided in CLSI EP5-A2. For each site, the standard deviation (SD) and coefficient of variation (CV%) for within-run, between-run, between-day, and within-device were estimated. For the combined data from two clinical sites, the SD and CV% for within-run, between-run, between-day, between-device and total precision were calculated also. The reproducibility results in each site met the specifications.
Precision/Repeatability
To demonstrate the within-run precision as a coefficient of variation from replicates of a single sample, ten replicates of K2EDTA whole blood samples around medical decision levels and the upper and lower limit of the analytical measuring range. Sample were selected and tested in the whole blood mode or the predilute mode at three clinical sites
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respectively. The mean, standard deviation (SD), and coefficient of variation (CV) were calculated for each sample. All data in each site passed specifications.
Linearity Range
WBC and PLT high-value analogs, which come from commercialized materials, were diluted to different values respectively. RBC/HGB linearity was performed using dilutions prepared from fresh whole blood. The whole blood was concentrated to obtain specimens to test the high linearity limit. Serial dilutions were prepared using the diluent for each parameter to create 7 subsequent dilutions. The mean of multiple measurements, three (3), from each of the 7 dilutions across the linearity range were used. Acceptable performance is indicated by the data fitting a linear regression line with a coefficient of determination (R2) of >0.95 and the parameters measured recovering within the bias limits for each parameters based on CLSI EP06-A.
Carryover
Carryover was determined for WBC, RBC, HGB and PLT. Testing was performed to test the different analytical cycle combinations of within mode for whole blood, within mode for predilute and mode. For each analytical cycle combination, whole blood and predilute sample with extremely elevated blood components (high sample) and with decreased blood components (low sample) were tested in triplicates according to H26-A2.
For whole blood and predilute sampling, within mode to mode for sampling carryover were calculated and the results were within specifications (≤ 0.5%) for WBC, RBC, HGB and (