X100 with Full Field PBS matched manual microscopy on 645 smears

In FDA's review of the X100 with Full Field PBS, examiners using its neural-network white-cell classification matched manual microscopy on 645 specimens, with 96.29% agreement.

  • 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 light microscopy of the same 645 specimens. Measured.

The system’s part
Not isolated. Examiners using the device were compared with manual microscopy. The study did not separate the networks' pre-classification from the examiners' corrections, and examiners judged red-cell morphology themselves.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Repetitive Task Automation
System
X100 with Full Field Peripheral Blood Smear Application
Made by
Scopio Labs Ltd.
Used by
Scopio Labs (method comparison against manual microscopy at three sites)
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 for X100 with Full Field Peripheral Blood Smear (PBS) Application (K201301). Cleared 2020-10-02.

    All 95% CI of slope and intercept and Pearson correlation coefficient met the acceptance criteria for accuracy measured by Deming regression for WBC differential.

Details

AI system

Workflow

Slides were prepared from each specimen and stained with a Romanowsky stain. The X100 reconstructed high-resolution images from captures under several illumination conditions.

Follow-up

Conditions for replication

A skilled user trained on the device reviews the suggested classification of every white cell. The specimens are peripheral blood collected in K2EDTA or K3EDTA tubes.

Entry details

Sector

Healthcare.

Purpose

Scopio Labs built the X100 with Full Field PBS application to locate and pre-classify white cells and estimate platelets on blood smears for trained users to review.

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). X100 with Full Field PBS matched manual microscopy on 645 smears (AIBD-0804). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0804.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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