Search Results
Found 3 results
510(k) Data Aggregation
K Number
K240636Device Name
HemoScreen Hematology Analyzer
Manufacturer
PixCell Medical Technologies
Date Cleared
2024-05-02
(57 days)
Product Code
GKZ
Regulation Number
864.5220Why did this record match?
Applicant Name (Manufacturer) :
PixCell Medical Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HemoScreen is a point-of-care (POC) automated hematology analyzer intended for the enumeration and classification of the following parameters in capillary and venous whole blood (K2EDTA anticoagulated): WBC, RBC, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, NEUT%, NEUT#, LYMP%, LYMP#, MONO%, MONO#, EO%, EO#, BASO%, and BASO#. The HemoScreen is for in vitro diagnostic use in clinical laboratories and/or POC settings for adults and children at least 2 years of age.
Device Description
HemoScreen is a point of care (POC), automated hematology analyzer that provides 20 common CBC parameters, including a 5-part leukocyte (WBC) differential, in capillary and venous whole blood samples. The HemoScreen analyzer (reader) is a tabletop device that is designed to use with a disposable reagent Cartridge. In addition to the Cartridge, the system includes a disposable Sampler with two glass capillaries which is used to collect the blood sample and then transfer it to the Cartridge.
Once the Cartridge is inserted into the reader, there are no further procedural steps; blood is expelled from the capillaries (Sampler) into the reagent compartments (Cartridge). The reader then mixes the blood sample with the reagents by alternately pressing compressible portions of the Cartridge, eventually causing the suspension of cells to flow into the microfluidic chamber. Cells flowing in the microfluidic chamber focus into a single-cell plane due to a patented physical phenomenon known as viscoelastic focusing.
The reader then captures images of the focused cells and analyzes them in real time using machine vision algorithms. When analysis is complete, the results are displayed to the user on the reader's touch screen and may be printed to an adjacent printer or exported to a USB flash drive. The Cartridge is ejected by the analyzer after analysis, and can then be safely disposed of, as the reagents and blood sample remain within the Cartridge.
The basic staining and microscopic image analysis performed by HemoScreen closely resembles the traditional blood smear and the hemocytometer counting chamber. Leukocytes are classified based on their staining properties and morphology, whereas absolute counts are obtained by counting the cells contained in a chamber of predetermined volume. Test results are obtained within less than six (6) minutes and the results are saved.
Quality Control: Commercial 3-level liquid quality controls, PIX-CBC Hematology Controls, are recommended for use with the HemoScreen. These controls cover all the tested parameters and are sampled the same way whole blood is sampled.
Software: The HemoScreen software displays an intuitive, simple-to-use user interface that is operated via the touch screen. The software is responsible for operating the device, performing the measurements, and recording the results.
Ask a Question
K Number
K222148Device Name
HemoScreen Hematology Analyzer
Manufacturer
PixCell Medical Technologies, Ltd.
Date Cleared
2023-08-16
(392 days)
Product Code
GKZ
Regulation Number
864.5220Why did this record match?
Applicant Name (Manufacturer) :
PixCell Medical Technologies, Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HemoScreen is a point-of-care (POC) automated hematology analyzer intended for the enumeration and classification of the following parameters in capillary and venous whole blood (K2EDTA anticoagulated): WBC, RBC, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, NEUT%, NEUT#, LYMP%, LYMP#, MONO%, MONO#, EO%, EO#, BASO%, and BASO#. The HemoScreen is for in vitro diagnostic use in clinical laboratories and/or POC settings for adults and children at least 2 years of age.
Device Description
HemoScreen is a point of care (POC), automated hematology analyzer that provides 20 common CBC parameters, including a 5-part leukocyte (WBC) differential, in capillary and venous whole blood samples. The HemoScreen analyzer (reader) is a tabletop device that is designed to use with a disposable reagent Cartridge. In addition to the Cartridge, the system includes a disposable Sampler with two glass capillaries which is used to collect the blood sample and then transfer it to the Cartridge.
Once the Cartridge is inserted into the reader, there are no further procedural steps; blood is expelled from the capillaries (Sampler) into the reagent compartments (Cartridge). The reader then mixes the blood sample with the reagents by alternately pressing compressible portions of the Cartridge, eventually causing the suspension of cells to flow into the microfluidic chamber. Cells flowing in the microfluidic chamber focus into a single-cell plane due to a patented physical phenomenon known as viscoelastic focusing.
The reader then captures images of the focused cells and analyzes them in real time using machine vision algorithms. When analysis is complete, the results are displayed to the user on the reader's touch screen and may be printed to an adjacent printer or exported to a USB flash drive. The Cartridge is ejected by the analyzer after analysis, and can then be safely disposed of, as the reagents and blood sample remain within the Cartridge.
The basic staining and microscopic image analysis performed by HemoScreen closely resembles the traditional blood smear and the hemocytometer counting chamber. Leukocytes are classified based on their staining properties and morphology, whereas absolute counts are obtained by counting the cells contained in a chamber of predetermined volume. Test results are obtained within six (6) minutes and the results are saved.
Quality Control: Commercial 3-level liquid quality controls, PIX-CBC Hematology Controls, are recommended for use with the HemoScreen. These controls cover all the tested parameters and are sampled the same way whole blood is sampled.
Software: The HemoScreen software displays an intuitive, simple-to-use user interface that is operated via the touch screen. The software is responsible for operating the device, performing the measurements, and recording the results.
Ask a Question
K Number
K180020Device Name
HemoScreen Hematology Analyzer
Manufacturer
PixCell Medical Technologies, Ltd.
Date Cleared
2018-10-29
(300 days)
Product Code
GKZ
Regulation Number
864.5220Why did this record match?
Applicant Name (Manufacturer) :
PixCell Medical Technologies, Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HemoScreen is a point-of-care (POC) automated hematology analyzer intended for the enumeration and classification of the following parameters in capillary and venous whole blood (K2EDTA anticoagulated): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, NEUT%, NEUT#, LYMP%, LYMP#, MONO%, MONO#, E0%, E0%, BASO %, and BASO#. The HemoScreen is for in vitro diagnostic use in clinical laboratories and/or POC settings for adults and children at least 2 years of age.
Device Description
HemoScreen is a point of care (POC), automated hematology analyzer that provides 20 common CBC parameters, including a 5-part leukocyte (WBC) differential, in capillary and venous whole blood samples. The HemoScreen analyzer (reader) is a tabletop device that is designed to use with a disposable reagent cartridge. In addition to the cartridge, the system includes a disposable sampler with two glass capillaries which is used to collect the blood sample and then transfer it to the cartridge. Once the cartridge is inserted into the reader, there are no further procedural steps; blood is expelled from the capillaries (sampler) into the reagent compartments (cartridge). The reader then mixes the blood sample with the reagents by alternately pressing compressible portions of the cartridge, eventually causing the suspension of cells to flow into the microfluidic chamber. Cells flowing in the microfluidic chamber focus into a single-cell plane due to a patented physical phenomenon known as viscoelastic focusing. The reader then captures images of the focused cells and analyzes them in real time using machine vision algorithms. When analysis is complete, the results are displayed to the user on the reader's touch screen and may be printed to an adjacent printer or exported to a USB flash drive. The cartridge is ejected by the analyzer after analysis, and can then be safely disposed of, as the reagents and blood sample remain within the cartridge. The basic staining and microscopic image analysis performed by HemoScreen closely resembles the traditional blood smear and the hemocytometer counting chamber. Leukocytes are classified based on their staining properties and morphology, whereas absolute counts are obtained by counting the cells contained in a chamber of predetermined volume. Test results are obtained within six (6) minutes and the results are saved.
Ask a Question
Page 1 of 1