X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application

by Scopio Labs  · Based in Israel → — Revolutionize the way you see, work and diagnose.
Hematology Laboratory Medicine Pathology

Contact for pricing
Regulatory Status Disclosed

Overview

The Scopio Labs X100HT with Slide Loader and its Full-Field Peripheral Blood Smear (FF-PBS) Application is an advanced AI-powered digital cell morphology solution designed to transform hematology laboratory workflows. This platform eliminates the need for manual microscopy by providing full-field digital imaging of peripheral blood smears at 100X oil immersion resolution, including the monolayer and feathered edge. It integrates a sophisticated AI-powered Decision Support System (DSS) that assists lab professionals with automated detection, pre-classification, and quantification of white blood cells (into 14-16 classes), red blood cell morphology evaluation (including AI-driven analysis for 23 parameters), and platelet estimations and clump identification. The X100HT model features a 30-slide loader, enabling high-throughput processing of up to 40 slides per hour for 200 WBC differentials, catering to the demands of large hospitals and laboratory networks. This end-to-end digital workflow significantly reduces turnaround times for sample reviews by up to 60% and facilitates remote review, collaboration, and consultation through secure, browser-based access, ushering in a new era of telehematology. The system aims to enhance accuracy, consistency, and efficiency in diagnosing blood-related conditions such as cancers, anemias, infections, and allergies, ultimately expediting patient access to life-saving treatments.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Full-field digital imaging at 100X oil immersion resolution
  • AI-powered Decision Support System (DSS)
  • Automated WBC detection, pre-classification (14-16 classes), and quantification
  • RBC morphology evaluation (including AI-driven analysis for 23 parameters)
  • Platelet estimation and detection (including identification of platelet clumps)
  • 30-slide loader for high-throughput processing (up to 40 slides/hour for 200 WBC Diff)
  • Remote review capabilities (telehematology, browser-based access)
  • End-to-end digital workflow
  • Reduced turnaround time for sample reviews (up to 60%)
  • Digital reporting and integration into Laboratory Information Systems (LIS)

Use Cases

  • Peripheral Blood Smear (PBS) analysis
  • Detection and diagnosis of blood-related diseases (cancers, anemias, infections, allergies)
  • Clinical decision support for hematology professionals
  • Remote consultation and collaboration among lab experts
  • Workflow optimization and efficiency in hematology laboratories
  • Enhancing consistency and standardization in cell morphology analysis

What Physicians Need to Know

LIS/LIMS Integration
Seamless LIS integration is supported, with results automatically documented in a digital report that can directly integrate into the LIS.
Supported Assay Types
Primarily supports Full-Field Peripheral Blood Smear (FF-PBS) analysis, including comprehensive WBC differentials (pre-classification into 14 or 16 classes), detailed RBC morphology evaluation (analyzing 23 parameters across thousands of cells), and accurate platelet estimations (including clump identification). It also offers a Full-Field Bone Marrow Aspirate (BMA) application, which is CE-marked and for Research Use Only in the US.
QC/QA Features
The system provides standardization and consistency in analysis. Lab professionals can review and verify AI-suggested pre-estimations and pre-classifications, and approve, reclassify, or augment cases with comments and annotations. Studies have demonstrated high levels of reproducibility and repeatability for WBC and platelet measurements.
Result Interpretation AI
Features an AI-powered Decision Support System (DSS) that performs automated WBC detection and pre-classification, analyzes over 10,000 RBCs across 1,000 fields of view for 23 morphological parameters, and pre-estimates platelets from 10 fields of view, including the identification of platelet clumps. The AI assists in analysis and grading, providing reliable and consistent information, while maintaining essential human expert oversight for final diagnostic decisions.
Critical Value Alerts
The AI-powered system assists in fast, early, and accurate detection and diagnosis of disease by identifying and pre-classifying pathological elements and abnormal cells, thereby supporting the identification of potentially critical findings for expert review.
Instrument Interfaces
The X100HT can be integrated with existing hematology workcells, such as the Beckman Coulter DxH 900 Workcell and DxH Slidemaker Stainer II, to create a fully integrated workflow from complete blood count (CBC) testing to slide staining and peripheral blood smear analysis.
Reference Range Intelligence
The AI-driven analysis provides suggested pre-classifications and pre-estimations for various cell types and morphological parameters, which are inherently compared against established reference ranges by the reviewing laboratory professional. Studies indicate that normal ranges for major WBCs determined by the Scopio system are comparable to manual methods.
Turnaround Time Impact
Significantly reduces turnaround time (TAT) for peripheral blood smear review by up to 60%. Studies have shown TAT reductions of 41.4% on the first day of the weekend, 33.1% on the second day, and eliminated backlogs by 59.1% on the first weekday. Overall morphology TAT in the laboratory can drop by 15.8% over a five-month period.
Physician Tip

Leverage the X100HT's full-field digital imaging and AI-powered decision support for enhanced diagnostic confidence and consistency in peripheral blood smear analysis. Utilize its remote review capabilities to facilitate timely consultations and accelerate treatment decisions, especially for critical cases or during off-hours. The comprehensive digital reports and annotations can improve communication and collaboration within the care team.

The X100HT is designed for seamless integration with Laboratory Information Systems (LIS) and can connect with automated hematology workcells (e.g., Beckman Coulter DxH 900 Workcell and DxH Slidemaker Stainer II) to create an end-to-end digital workflow. This integration streamlines operations from CBC to slide review, minimizing manual steps and enhancing overall lab efficiency.

Details

Category Lab & Diagnostics, Pathology AI
Pricing Contact for pricing
DeploymentOn-premise device with browser-based access through secure hospital/laboratory network.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The X100HT with Full Field PBS is FDA 510(k) cleared (K220013) and intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears. It assists qualified technologists in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images, for in vitro diagnostic and professional use only.

Integrations
EHR Not specified
Specialties Hematology, Laboratory Medicine, Pathology

What the Web Says

The Scopio Labs X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application is a digital morphology system designed to automate the classification of white blood cells (WBCs) and identify pathological elements in peripheral blood smears. It aims to accelerate PBS analysis, increase workflow efficiency, and provide remote review capabilities, thereby reducing the reliance on manual microscopy.

Overall: Positive

Strengths

  • Automates WBC classification and identification of pathological elements.
  • Strong correlation with manual microscopy for neutrophils and lymphocytes.
  • High agreement between digital pre-classification and expert post-classification for all WBC categories.
  • Enhances diagnostic accuracy with expert post-classification.
  • Reduces turnaround time for sample reviews by up to 60%.
  • Enables remote review and collaboration, supporting tele-hematology.

Limitations

  • Moderate diagnostic accuracy for detecting blasts, immature myeloid cells, and NRBCs, which improves with expert review.
  • Requires skilled users trained in the device and blood cell identification.
  • No specific information found regarding pricing or cost savings beyond workflow efficiency.
  • Limited independent reviews from G2, Capterra, or Reddit were found.

Based on reviews from: PubMed, Semantic Scholar, accessdata.fda.gov, Scopio Labs (scopiolabs.com), ResearchGate, CAP TODAY, Convenzis, PR Newswire, Association for Pathology Informatics, Beckman Coulter

Last updated: 2026-07-20

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Videos

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Frequently Asked Questions

The X100HT utilizes an AI-powered Decision Support System (DSS) to pre-classify white blood cells (WBCs), evaluate red blood cell (RBC) morphology, and estimate platelets, providing full-field imaging at 100x magnification. This system offers reliable, consistent information to support diagnostic decisions, aiming to enhance workflow efficiency and standardization for lab professionals.
The X100HT with the Full-Field Peripheral Blood Smear Application is FDA-cleared and CE-marked, indicating its compliance with relevant medical device regulations. The system facilitates secure, browser-based access to images through the hospital network, which is crucial for maintaining data privacy and security standards, though specific HIPAA compliance details are not explicitly detailed in the provided information.
The X100HT aims to replace traditional manual microscopy, which is time-consuming and labor-intensive, by offering an end-to-end digital solution with high-resolution, full-field imaging. It significantly reduces turnaround time for sample reviews by up to 60% and increases workflow efficiency, overcoming the resolution-versus-field-of-view trade-off often found in other automated systems.
The Scopio X100HT Digital Cell Morphology system has been listed at approximately $228,540.00. While specific ROI calculations are not provided, the system is designed to reduce turnaround time by 60% and improve workflow efficiency, suggesting substantial operational savings and faster diagnoses.
While the X100HT shows reliable performance for WBC differential analysis, studies indicate moderate diagnostic accuracy for detecting blasts, immature myeloid cells, and nucleated red blood cells, which improves with expert review. AI algorithms can also exhibit biases stemming from training data or model development, potentially leading to unequal performance across different patient demographics.
The AI system functions as a Decision Support System, meaning lab professionals are required to review and verify the AI's pre-estimations and pre-classifications; the final diagnostic decision remains with the trained human expert. It integrates into existing workflows by providing a digital platform for remote review and collaboration, eliminating the need for manual microscopy and streamlining the pathologist's review process.
Scopio Labs offers an interactive training portal called 'Scopio Learn' to help users build expertise on the X100HT system and its PBS application. This portal provides videos, product data, and usage requirements, covering aspects like slide preparation, loading, maintenance, and troubleshooting.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19

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