EasyCell white cell counts track manual microscopy in FDA's review

In FDA's review, EasyCell's technologist-reviewed white cell differentials on 304 specimens correlated with manual microscopy at 0.93 to 0.99, including 0.99 for neutrophils.

  • 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 WBC differential by microscopy on the same specimens. Measured.

Without the system
Manual 200-cell differential (reference)
With it
Correlation coefficient 0.99 for neutrophils, 0.98 for lymphocytes, 0.97 for eosinophils and 0.93 for monocytes
The system’s part
Not isolated. FDA's reviewers write that a neural-network classifier preclassifies the white cells. The study compared technologist-reviewed results with manual microscopy and did not report the classifier's suggestions alone or compare work with and without the device.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Repetitive Task Automation
System
EasyCell Cell Locator (EasyCell)
Made by
Medica Corporation
Used by
Medica Corporation (method comparison study at three sites)
Where
Three study sites (not named in the decision summary)
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
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 summary, k092116: EasyCell Cell Locator (Medica Corporation). Decision date 12 May 2010.

    A total of 304 specimens, including 155 specimens from normal (healthy) subjects and 149 from subjects with specific disease conditions, were collected and analyzed at three sites.
    Preclassification is accomplished using a neural-network classifier.

Details

AI system

Workflow

Two microscopes with CCD cameras captured images of cells on oiled smears. A neural-network classifier sorted the white cells into eight categories. Technologists reviewed each suggested classification.

Follow-up

Conditions for replication

Skilled operators trained on the device and in identifying blood cells use it. Daily quality control on one normal and one abnormal slide passes before samples are run.

Entry details

Sector

Healthcare (laboratory hematology).

Purpose

Medica built the EasyCell Cell Locator to locate and display images of blood cells on stained smears and to suggest a class for each white cell, which a technologist confirms.

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). EasyCell white cell counts track manual microscopy in FDA's review (AIBD-0905). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0905.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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