DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER

by CELLAVISION AB  · Based in Sweden → — Pioneering digital hematology microscopy solutions for automated cell analysis.
Hematology Laboratory Medicine Pathology

Regulatory Status Disclosed

Overview

The DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER, developed by CellaVision AB, was an early automated cell-locating device designed for in-vitro diagnostic use in clinical laboratories. Launched in early 2001, it aimed to automate and simplify the process of performing differential counts of white blood cells (WBC) and characterizing red blood cell (RBC) morphology, tasks traditionally conducted through manual microscopy. The system utilized a proprietary software system (Cytologica) combined with a sophisticated hardware platform to automatically locate and capture high-quality digital images of blood cells on peripheral blood specimens. It leveraged artificial neural networks for the pre-classification of leukocytes, presenting these images for review and verification by a skilled operator. While innovative for its time, the DiffMaster Octavia was CellaVision’s first product and was later discontinued, with approximately 80 systems sold before being succeeded by more automated and higher-throughput models like the CellaVision DM96.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated cell locating on blood smears
  • Differential count of white blood cells (WBC)
  • Characterization of red blood cell (RBC) morphology
  • Digital imaging of blood cells
  • Software-based pre-classification using artificial neural networks
  • Operator review and verification of cell classification
  • Aimed at improving efficiency and diagnostic quality in hematology labs
  • High image quality and user-friendly interface

Use Cases

  • Routine analysis of peripheral blood samples in hematology laboratories
  • Automated differential count of white blood cells
  • Automated characterization of red blood cell morphology
  • Preclassification of leukocytes in patients with hematological diseases
  • Replacing or assisting manual microscopy for blood cell analysis

What Physicians Need to Know

LIS/LIMS Integration
Automated hematology analyzers are designed for connectivity and integration with Laboratory Information Systems (LIS) to ensure real-time data transfer to physicians.
Supported Assay Types
The DiffMaster Octavia was designed for peripheral blood applications, analyzing white blood cells (WBCs) and red blood cells (RBCs). It pre-classified WBCs into 12 cell classes and pre-characterized RBCs into 6 types based on shape, form, and color. It performs morphological classification of RBCs and WBCs in peripheral blood smears.
QC/QA Features
The system contributes to standardized and reproducible results in automated cell counting. Laboratories rely on precise analyzers to avoid problems related to variability in results.
Result Interpretation AI
The DiffMaster Octavia utilized artificial neural networks for automatic cell location and image processing for preclassification of blood cells. It provides a decision support system that, combined with a qualified morphologist, can generate high-quality leukocyte differential count reports. The system pre-classified 89% of all leukocytes correctly with good reproducibility.
Critical Value Alerts
While not explicitly detailed for the DiffMaster Octavia, modern hematology analyzers with AI analysis aim to provide interpretable information beyond traditional flag alarms, helping clinicians identify abnormal cells and hematological diseases.
Instrument Interfaces
The DiffMaster Octavia system included a microscope, a 3-chip color charge-coupled device (CCD) camera, an automated motorized stage holder, and electronic hardware for motor and light control.
Reference Range Intelligence
Automated hematology analyzers typically include reference ranges for each parameter in their reports. The DiffMaster Octavia was mentioned in the context of reference ranges in early CellaVision systems.
Turnaround Time Impact
Automated analyzers increase speed and efficiency, processing a large number of samples quickly. The DiffMaster Octavia had a total analysis time of 5.4 minutes per slide (for 100 WBCs/slide). Automated systems aim to reduce turnaround time and staff requirements. AI analysis in hematology can decrease turnaround time and reduce clinician workload.
Microbiology ID Support
CellaVision offers reagents that cover various fields, including microbiology, but specific microbiology ID support for the DiffMaster Octavia is not highlighted.
Physician Tip

The DiffMaster Octavia, while an early innovation, provided automated pre-classification of WBCs and pre-characterization of RBCs using artificial neural networks, serving as a decision support system. Physicians should be aware that while it offered good correlation with manual differentiation for WBC analysis, its classification accuracy could depend on the type of pathological changes in the blood sample, performing most effectively with non-pathological samples. Verification by a qualified morphologist was still crucial for generating high-quality reports.

The DiffMaster Octavia was CellaVision's first product, launched in 2001 and is now discontinued. While modern hematology analyzers emphasize seamless integration with LIS/LIMS for efficient data management, specific integration details for the legacy DiffMaster Octavia are not readily available. However, the general benefit of automated hematology analyzers includes connectivity and integration with laboratory systems.

Details

Category Lab & Diagnostics, Pathology AI
Pricing Unknown
DeploymentOn-premise (physical analyzer)
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Hematology, Laboratory Medicine, Pathology

What the Web Says

The CellaVision DiffMaster Octavia Automatic Hematology Analyzer is an automated system designed for morphological classification of red blood cells (RBCs) and white blood cells (WBCs) in peripheral blood smears. It was CellaVision's first instrument, featuring a peripheral blood application that automatically identifies the optimal examination area on a blood film, locates WBCs, and pre-classifies them into one of 12 cell classes using artificial neural networks. The system also pre-characterizes RBCs into 6 types based on shape, form, and color. While effective for non-pathological blood samples, its accuracy can depend on the type of pathological changes present in the sample, and manual review is often considered necessary for pathological cells.

Overall: Mixed

Strengths

  • Automated morphological analysis of peripheral blood films, including preclassification of RBCs and WBCs.
  • Good correlation with manual differentiation for WBC analysis.
  • Identifies optimal examination area (monolayer) on blood film automatically.
  • Pre-classifies WBCs into 12 cell classes using artificial neural networks.
  • Pre-characterizes RBCs into 6 types based on shape, form, and color.
  • Core functionality has been enhanced over 20 years based on customer feedback, including better cell pre-classification and new workflow-based functionalities.

Limitations

  • Classification accuracy depends on the type of pathological changes in the blood sample.
  • Operates most effectively in the analysis of non-pathological blood samples.
  • Manual review is often considered necessary for pathological cells.
  • Slower analysis time compared to newer models like the CellaVision DM96 (5.4 min/slide for Octavia vs. 3.2 min/slide for DM96).

Based on reviews from: physicianaitools.com, jst.go.jp, scribd.com, scispace.com, researchgate.net, nih.gov, oup.com, cellavision.com

Last updated: 2026-10-29

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Press & Coverage

fda.gov
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
This is a 510(k) Premarket Notification document for the DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER by CellaVision AB. It lists the applicant and correspondent contact information, regulation number, classification product code (JOY24), and the date of the document.
2026-09-21
fda.gov
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
This FDA entry mentions the DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER with a 510(k) clearance date of January 31, 2008.
2026-10-12
fda.report
CellaVision AB FDA Filings
This page lists various FDA filings by CellaVision AB, including the DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER with a filing date of March 15, 2001.
2001-03-15
innolitics.com
AI/ML-Enabled Medical Devices: A Regulatory Landscape Overview (2026)
This article discusses the regulatory landscape of AI/ML-enabled medical devices and mentions the CellaVision AB DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER (K031715) as an example of a hematology device with a 510(k) clearance from 2004, noting that hematology devices dominate in volume but are often not perceived as 'AI' despite their embedded role in lab workflows.
2026-04-28
innolitics.com
AI/ML-Enabled Medical Devices: A Regulatory Landscape Overview (2026)
The article highlights that the CellaVision DiffMaster Octavia (2001) is included in the range of AI/ML-enabled medical devices, indicating its early presence in the field of automated hematology.
2026-04-28
jst.go.jp
Japanese Journal of Medical Technology, Volume 75 (2026) Issue 1
This journal issue includes a mention of the DiffMaster Octavia Automatic Hematology Analyzer by CellaVision AB in the context of red blood cell counting.
2026-01-25

Videos

Product demos, reviews, and walkthroughs for DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER.

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Frequently Asked Questions

The DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER was designed for differential counting of blood leukocytes and analyzing white and red blood cells in peripheral blood smears. It automatically identifies the optimal examination area on a blood film, locates white blood cells, and pre-classifies them into one of 12 cell classes using artificial neural networks. It also pre-characterizes red blood cells into 6 types based on shape, form, and color.
The DIFFMASTER OCTAVIA, along with similar automated systems, operates most effectively in the analysis of non-pathological blood samples. Its classification accuracy depends on the type of pathological changes in the blood sample, and it may be unable to reliably classify immature and abnormal cells.
The DIFFMASTER OCTAVIA correctly preclassified 89% of all leukocytes with good reproducibility. After verification, the agreement between the system and manual microscopy was 91% for both abnormal and normal samples. The clinical sensitivity was 98% and specificity 82%, with slightly higher sensitivity for identifying blast cells compared to manual microscopy.
The DiffMaster Octavia has been discontinued. CellaVision recognized the need for more automated systems with higher throughput, leading to the development of the CellaVision DM96, launched in 2003, and later the CellaVision DM9600 in 2014. For smaller laboratories, the CellaVision DC-1 was launched in 2019.
Automated hematology analyzers are subject to compliance with standards such as ISO 17025 for the competence of testing and calibration laboratories, ISO 15189 for quality and competence in medical laboratories, and IEC 61010 for safety requirements of electrical equipment used in laboratories.
While the specific pricing for the discontinued DiffMaster Octavia is not readily available, hematology analyzer prices generally range from $3,000 for entry-level 3-part analyzers to over $150,000 for high-end fluorescence 5-part systems with advanced automation. The total cost of ownership also includes reagents, service, and consumables. The DiffMaster Octavia was CellaVision's first product, launched in 2001, and only about 80 systems were sold, indicating it was an early, specialized system.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18
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