An Automated Cell-Locating Device is designed to assist in locating blood cells on a peripheral blood smear, simplifying the process for operators to identify and classify each cell type. The device uses advanced imaging technology and automation to scan the blood smear, detecting and locating individual cells. It often utilizes optical methods such as bright-field or fluorescence microscopy to enhance the visibility of blood cells. The system can automatically recognize cell features like size, shape, and color, allowing for the precise identification of various cell types (e.g., red blood cells, white blood cells, and platelets). Peripheral blood, typically collected from the arm or other extremities, is analyzed in this manner for various diagnostic purposes, such as detecting abnormalities or diseases like anemia, leukemia, or infections.

Intended Use of Analyzer, Chromosome, Automated

An Automated Cell-Locating Device is a Device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body’s extremities, such as the arm.)

Intended Use:

Device, Automated Cell-Locating device is intended to automate the detection, localization, and classification of cells and cellular elements in blood and body fluid specimens prepared as smears or microscope slides. The system assists trained laboratory personnel by providing digital images, measurements, and candidate cell classifications to facilitate manual review by qualified clinical laboratory professionals. The device’s use is to support haematological and cytological evaluation but is not intended to be used as a standalone diagnostic tool for patient management; results must be interpreted in conjunction with clinical findings and other laboratory data.

Device Description:

The Device, Automated Cell-Locating system is a computer-assisted microscopy and image analysis platform that integrates optical imaging hardware, digital image capture, and software algorithms to identify and classify cellular elements on microscope slides.

Core Components

• Optical Imaging Unit
• Digital Camera
• Image Processing Software
• User InterfaceData Storage and Connectivity

The system typically includes calibration slide materials and quality control reagents or software tools to verify consistent performance. Depending on the specific implementation, the device may be configured as a standalone bench instrument or as a networked workstation.

Analyzer, Chromosome, Automated

Intended Use:

Analyzer, Chromosome, Automated intended to automatically locate and present images of blood cells on prepared peripheral blood smear slides. The device assists laboratory professionals by scanning and identifying cells, enabling operators to visualize, locate, and classify hematologic cells (e.g., red blood cells, white blood cells, and platelets) and support differential cell morphology analysis.

Device Description:

Automated Cell-Locating Device is a laboratory instrument that combines optical imaging, slide handling, software‐based image analysis, and user interface components to identify and present cells on peripheral blood smear slides for review and interpretation.

• Precision
• Reproducibility
• Accuracy
• Software Verification and Validation Testing
• Electromagnetic Compatibility (EMC) and Electrical Safety

Clinical Testing:

No Guidance available for 510k submission