Advanced RBC Application sorted red cells close to manual microscopy

In FDA's review of the Advanced RBC Application, operator-reviewed results for schistocytes, target cells, sickle cells, tear drop cells and parasites matched manual microscopy with 90.6% efficiency.

  • Not rated an organization

    The study measured agreement with manual microscopy, and no gain in time or accuracy at any laboratory is reported.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Intended benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

Manual microscopy of the same smears. Measured.

The system’s part
Not isolated. The study compared operator-reviewed results with manual microscopy. It did not report the networks' suggestions on their own or compare work with and without the module.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Repetitive Task Automation
System
Advanced RBC Application (CellaVision DM96 and DM1200)
Made by
CellaVision AB
Used by
CellaVision (method comparison studies at five clinical sites)
Where
Five clinical sites, two in the United States and three outside it
Stage
Tested in a laboratory
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Identifying Objects, Actions, and Events, Processing Information
Collections
Scrutiny and findings, Cross-border records
Last revised
31 October 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. 510(k) substantial equivalence determination decision memorandum for the Advanced RBC Application on CellaVision DM96 and DM1200 (K171315). Cleared 2017-08-01.

    To determine agreement between the Advanced RBC Application and manual microscopy reference method, the efficiency, analytical sensitivity and analytical specificity were calculated along with the 95% confidence intervals for color, size and shape. Comparison between the DM system with Advanced RBC Application and the automated differential cell counter method for size was provided as overall agreement, positive percent agreement (PPA) and negative percent agreement (NPA) along with the 95% confidence interval. The results met the predefined acceptance criteria.

Details

AI system

Workflow

Venous blood was collected in K3EDTA tubes, and one slide was prepared from each sample. At one site an expert operator confirmed or overrode the suggested grading, and at the others operators re-characterized individual cell images.

Follow-up

Conditions for replication

Skilled operators trained on the device and in recognizing blood cells review the suggestions. The blood samples have been flagged as abnormal by an automated cell counter.

Entry details

Sector

Healthcare.

Purpose

CellaVision built the Advanced RBC Application to pre-characterize red blood cell morphology on blood smears for skilled operators to confirm or modify.

Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.

Cite this record

Peter H. Vartanian. (2026). Advanced RBC Application sorted red cells close to manual microscopy (AIBD-0805). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0805.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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