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DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER

CELLAVISION AB • Hematology • 03/15/2001

510(k)IEC 62304 Class A
FDA Summary PDF

Device Purpose

The DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER by CellaVision AB utilizes advanced imaging and software algorithms to automate the morphological classification of blood cells from peripheral smears, aiming to improve laboratory efficiency and diagnostic accuracy. Clinical studies indicate the system's effectiveness, particularly with non-pathological samples, achieving an 87% preclassification accuracy for white blood cells and facilitating standardized hematological assessments.

Summary

The DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER, developed by CellaVision AB, is an automated system engineered to locate and assist in the morphological classification of red and white blood cells from peripheral blood smears. Its core methodology relies on sophisticated advanced imaging technology coupled with specialized software algorithms. This combination is designed to significantly enhance the efficiency and accuracy of hematological analyses by automating the traditionally labor-intensive process of cell identification and classification, thereby streamlining laboratory workflows and reducing the potential for human error in microscopic review. Clinical evaluations of the DIFFMASTER OCTAVIA have demonstrated its effectiveness in its designated tasks, highlighted by an 87% preclassification accuracy for white blood cell analysis. The system is reported to perform optimally when processing non-pathological blood samples, delivering rapid results that support timely clinical decision-making. By integrating this technology, laboratories can promote greater consistency and standardization in hematological assessments, contributing to improved patient care through more reliable and efficient diagnostic support.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

Hematology AnalyzerMorphological ClassificationBlood SmearsAutomated Cell IdentificationAdvanced ImagingSoftware AlgorithmsWhite Blood CellsRed Blood CellsLaboratory WorkflowPreclassification Accuracy

Device Metadata

Submission Number
K003301
Company
CELLAVISION AB
Panel
Hematology
Product Code
N/A
Data Type
Images
Clinical Function
Assessment
AI Function
Analysis
AI Subclass
detection

Relevant Clinical Questions

  • Q1. How does the DIFFMASTER OCTAVIA's performance in classifying pathological blood samples (e.g., those with blasts or dysplastic cells) compare to manual microscopy and other automated systems?; What specific imaging techniques and software algorithms are utilized by the DIFFMASTER OCTAVIA to achieve its reported 87% preclassification accuracy for white blood cells?; What is the system's typical throughput (samples processed per hour) and how does its integration affect overall laboratory turnaround times for differential counts?; Are there specific types of artifacts or sample conditions that can significantly impact the DIFFMASTER OCTAVIA's accuracy or ability to locate and classify cells?; What are the validation and quality control procedures recommended by CellaVision AB to ensure ongoing optimal performance and reliability of the DIFFMASTER OCTAVIA in a clinical setting?

Risk Classification

ESL Analysis
FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class A (software safety classification); Authorized before §524B enforcement

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Cybersecurity Evidence

Powered by SBOMator™

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score5/100
SBOM Evidence⚠ Not mentioned in summary
Cyber Risk Assessment⚠ Not mentioned in summary
Postmarket Plan⚠ Not mentioned in summary
§524B ApplicableNo

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials
- Not detected
ML-BOMMachine Learning Bill of Materials(algorithm)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials
- Not detected
HBOMHardware Bill of Materials
- Not detected
CBOMCryptography Bill of Materials
- Not detected
VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange
- Not detected
OBOMOperations Bill of Materials
- Not detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of ML-BOM detected in AI-generated device summary.

• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.

• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.

• Not detected in AI-generated device summary: SBOM, SaaSBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER - CELLAVISION AB | ESL FDA AI Device Intelligence