(186 days)
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No
The summary describes a standard automated hematology analyzer with distinct hardware modules and data processing, but there is no mention of AI, ML, or related concepts like training/test sets for algorithmic development.
No.
The device is described as an in-vitro diagnostic hematology analyzer; it is used for analyzing blood samples, not for treating patients.
Yes
The "Intended Use / Indications for Use" section explicitly states that the CELL-DYN® 4000 System is "intended for in-vitro diagnostic use."
No
The device description clearly outlines multiple hardware components (Analyzer, Autoloader, Pneumatic Unit, Data Station, Color Printer) that are integral to the system's function. While the Data Station includes software, the device is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The CELL-DYN® 4000 System is a fully automated hematology analyzer intended for in-vitro diagnostic use in the clinical hematology laboratory of a hospital, medical clinic, or reference laboratory."
This statement directly identifies the device as intended for in-vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The CELL-DYN® 4000 System is a fully automated hematology analyzer intended for in-vitro diagnostic use in the clinical hematology laboratory of a hospital, medical clinic, or reference laboratory.
Product codes
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Device Description
The CELL-DYN® 4000 System has five main modules: the Analyzer, which aspirates, dilutes and analyzes each whole blood specimen; the Autoloader, which automatically identifies, mixes, and presents specimens for processing; the Pneumatic Unit, which controls fluid movement in the Analyzer and tube movement in the Autoloader; the Data Station, which controls all system processing and provides the primary operator interface with the system; and the Color Printer, which generates reports automatically or on demand.
The CELL-DYN 4000 is designed to analyze EDTA-anticoagulated whole blood. The analyzer counts, sizes and classifies blood cells by the combination of flow cytometry methods: Laser Optical Scatter and Fluorescence, Focused Flow Impedance, and Absorption Spectrophotometry. The CELL-DYN® 4000 System uses an Argon-ion laser as the optical light source. The Optical Bench detects light in the form of scatter from blood cell surfaces and internal structures, or fluorescent light from specially stained blood cells.
For the WBC parameters and NRBCs, whole blood is diluted with a reagent containing a red fluorescent dye. Data are simultaneously collected for four angles (0°, 7°, 90°, and 90ºD) of scatter and red fluorescence (FL3) as each cell passes through the laser beam. NRBCs, identified by fluorescence, are excluded automatically from the WBC count. For the RBC and the PLT parameters, whole blood is diluted with a reagent that prepares the cells for measurement. The dilution is split and measured by both laser optical scatter (7° and 90°) and Focused Flow Impedance with Injection Metering.
For the hemoglobin parameters, whole blood is diluted with a cyanide free reagent and the hemoglobin is measured optically by absorbance (540nm).
For the reticulocyte parameters, an aliquot of the RBC/PLT dilution is diluted with a reagent containing a green fluorescent dye. Data are collected for scatter (7º) and green fluorescence (FL1) as each cell passes through the laser beam.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The data compiled to support the claim that the CELL-DYN® 4000 System is substantially equivalent to the Abbott CELL-DYN® 3500 System includes accuracy, precision, linearity, and carryover.
The data supports the claim that the CELL-DYN® 4000 System is substantially equivalent to the Abbott CELL-DYN® 3500 System for the hemagram and automated WBC differential parameters and to the Becton Dickinson FACScan™ for the reticulocyte parameters. The accuracy, precision, and linearity data shows performance to manufacturer's specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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CELL-DYN ® 4000 System
K96K439
510(k) Notification
510(k) Summary Of Safety And Effectiveness Information Supporting A Substantially Equivalent Determination
OCT 18 1996
The following information presented in the Premarket Notification 510(k) for the CELL DYN® 4000 System constitutes data supporting a substantially-equivalent determination. Substantial equivalence is demonstrated between the CELL-DYN® 4000 System and the Abbott CELL-DYN 3500 Multi-Parameter Automated Hematology Analyzer, #K951496/S001 for the hemagram and white cell (WBC) differential parameters. Substantial equivalence is also demonstrated between the CELL-DYN® 4000 System and the Becton Dickinson FACScan™ Flow Cytometer ReticCOUNT™ Reticulocyte Enumeration Software, #K872166/A for reticulocytes. For enumeration of nucleated red blood cells (NRBCs) equivalence is demonstrated by comparison to the manual microscopic WBC differential count.
Intended Use: The CELL-DYN® 4000 System is a fully automated hematology analyzer intended for in-vitro diagnostic use in the clinical hematology laboratory of a hospital, medical clinic, or reference laboratory.
Device Description: The CELL-DYN® 4000 System has five main modules: the Analyzer, which aspirates, dilutes and analyzes each whole blood specimen; the Autoloader, which automatically identifies, mixes, and presents specimens for processing; the Pneumatic Unit, which controls fluid movement in the Analyzer and tube movement in the Autoloader; the Data Station, which controls all system processing and provides the primary operator interface with the system; and the Color Printer, which generates reports automatically or on demand.
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| specimen and report the following hematological parameters: | |
|---|---|
| White Blood Cell Parameters: | Red Blood Cell Parameters: |
| WBC -- White Blood Cell or leukocyte count | RBC -- Red Blood Cell or erythrocyte count |
| NEU -- Neutrophil absolute count | HCT -- Hematocrit |
| %N -- Neutrophil percent | MCV -- Mean Corpuscular Volume |
| LYM -- Lymphocyte absolute count | RDW -- Red Cell Distribution Width |
| %L -- Lymphocyte percent | NRBC -- Nucleated Red Blood Cell absolute count |
| MONO -- Monocyte absolute count | NR/W -- Nucleated Red Blood Cell percent of WBC count |
| %M -- Monocyte percent | Hemoglobin Parameters: |
| EOS -- Eosinophil absolute count | HGB -- Hemoglobin concentration |
| %E -- Eosinophil percent | MCH -- Mean Corpuscular Hemoglobin |
| BASO -- Basophil absolute count | MCHC -- Mean Corpuscular Hemoglobin Concentration |
| %B -- Basophil percent | |
| *vWF -- Viable White Cell fraction | |
| *BAND -- Band Neutrophil absolute count | Reticulocyte Parameters: |
| *%BD -- Band Neutrophil percent | RETC -- Reticulocyte concentration |
| *IMMG -- Immature Granulocyte absolute count | %R -- Reticulocyte percent of RBC count |
| *%IG -- Immature Granulocyte percent | *IRF -- Immature Reticulocyte Fraction |
| *BLST -- Blast absolute count | Platelet Parameters: |
| *%BL -- Blast percent | PLT -- Platelet Count |
| *VARL -- Variant Lymphocyte absolute count | MPV -- Mean Platelet Volume |
| *%VL -- Variant Lymphocyte percent | *PDW -- Platelet Distribution Width |
| *PCT -- Plateletcrit |
The CELL-DYN 4000 is designed to analyze EDTA-anticoagulated whole blood
- These parameters are provided for laboratory use only and are not reportable in the US
Principles of Operation: The analyzer counts, sizes and classifies blood cells by the combination of flow cytometry methods: Laser Optical Scatter and Fluorescence, Focused Flow Impedance, and Absorption Spectrophotometry. The CELL-DYN® 4000 System uses an Argon-ion laser as the optical light source. The Optical Bench detects light in the form of scatter from blood cell surfaces and internal structures, or fluorescent light from specially stained blood cells.
For the WBC parameters and NRBCs, whole blood is diluted with a reagent containing a red fluorescent dye. Data are simultaneously collected for four angles (0°, 7°, 90°, and 90ºD) of scatter and red fluorescence (FL3) as each cell passes through the laser beam. NRBCs, identified by fluorescence, are excluded automatically from the WBC count. For the RBC and the PLT parameters, whole blood is diluted with a reagent that prepares the cells for measurement. The dilution is split and measured by both laser optical scatter (7° and 90°) and Focused Flow Impedance with Injection Metering.
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510(k) Notification
For the hemoglobin parameters, whole blood is diluted with a cyanide free reagent and the hemoglobin is measured optically by absorbance (540nm).
For the reticulocyte parameters, an aliquot of the RBC/PLT dilution is diluted with a reagent containing a green fluorescent dye. Data are collected for scatter (7º) and green fluorescence (FL1) as each cell passes through the laser beam.
Similarities and Differences: The CELL-DYN® 4000 System has similarities to one or more of the methods of determination for hemagram and automated WBCs differential parameters used by the following hematology analyzers: Coulter® Counters (Model ZBI, Hemoglobinometer, S-Plus Series and STKS); Sysmex™ NE Series; Technicon H*1™ Series; Becton Dickinson FACScan™, and Abbott CELL-DYN® 3000 Series. The CELL-DYN® 4000 System has similarities to one or more of the methods of determination for reticulocyte enumeration used by the Becton Dickinson FACScan™ and the Sysmex™ R-3000.
The Coulter® Counters (Model ZBI, S-Plus Series and STKS), Abbott CELL-DYN® 3000 Series, and the CELL-DYN® 4000 System are similar in that they use impedance for counting and sizing RBCs and PLTs. The CELL-DYN 4000 and the Sysmex™ NE series are similar in that they both use Focused Flow Impedance to count and size RBCs and PLTs. The Technicon H*1™ series and the CELL-DYN® 4000 System are similar in that they both use Injection Metering to measure RBCs and PLTs optically. The CELL DYN® 4000 System is different in that it counts RBCs and PLTs by both the optical and impedance methods and compares the data as an internal quality check. WBCs are counted and classified by the Abbott CELL-DYN® 3000 Series Systems and the CELL-DYN® 4000 System in a very similar manner using four simultaneously collected angles of laser light scatter. They are different in that the Abbott CELL-DYN® 3000 Series Systems use a helium neon laser, while the CELL-DYN® 4000 System uses an Argon-ion laser that allows fluorescent data to be collected simultaneously with the optical scatter data. This change enables the CELL-DYN 4000 to count and classify WBCs, NRBCs, and fragile (nonviable) WBCs. The Becton Dickinson FACScan™ and the CELL-DYN® 4000 System both use an Argon-ion laser. The FACScan is also capable of identifying NRBCs and non-viable WBCs. NRBCs are stained for enumeration by both the CELL-DYN® 4000 System and the manual microscopic differential.
The Becton Dickinson FACScan™, the Sysmex™ R-3000, and the CELL-DYN® 4000 System are similar in that they enumerate reticulocytes in EDT A-anticoagulated whole blood using optical laser scatter and fluorescence. They are different in that for the Becton Dickinson FACScan™, specimens are externally stained with Thiazol Orange an incubated for 90 minutes and then manually presented for measurement. For the Sysmex™ R-3000, specimens are automatically diluted and stained using Auromine Orange and then measured. The CELL-DYN® 4000 System is different in that it automatically dilutes the
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specimen with a fast acting proprietary dye which requires no incubation prior to measurement.
Equivalency Data: The data complied to support the claim that the CELL-DYN® 4000 System is substantially equivalent to the Abbott CELL-DYN® 3500 System includes accuracy, precision, linearity, and carryover.
The data supports the claim that the CELL-DYN® 4000 System is substantially equivalent to the Abbott CELL-DYN® 3500 System for the hemagram and automated WBC differential parameters and to the Becton Dickinson FACScan™ for the reticulocyte parameters. The accuracy, precision, and linearity data shows performance to manufacturer's specifications.
Conclusion: The CELL-DYN® 4000 System shows an evolution of the technologies used on one or more of the currently available analyzers to count, size, and classify whole blood cells and their related parameters, and more specifically to the technologies used on the Abbott CELL-DYN® 3500 System and the Becton Dickinson FACScan™.
The 510(k) Summary was prepared and submitted by:
Janice E. Brown Regulatory Affairs Manager Abbott Diagnostics 5440 Patrick Henry Drive Santa Clara, CA 95054
Phone: 408 567-3512 408 982-4863 Fax: