X100 with Full Field Peripheral Blood Smear (PBS) Application

K201301

Scopio Labs LTD. · cleared 2020-10-02 · product code JOY · Hematology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“X100 with Full Field Peripheral Blood Smear Application (Scopio's Full Field PBS) automatically locates and presents high resolution digital images from fixed and stained peripheral blood smears. Cell images are analysed using standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells.”
Algorithmdeterministic artificial neural networks (ANN's)
source quote (p.6)
“Cell images are analysed using standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.11)
“Software verification and validation testing were conducted and documentation was provided as recommended by FDA's guidance. The software application was considered as a “moderate” level of concern, since a malfunction failure or latent design flaw in the software could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that could lead to a minor injury.”

Validation studies (3)

Reader study (MRMC)

n=645 cases · 3 site(s)

endpoints: WBC differential efficiency; WBC differential sensitivity; WBC differential specificity; RBC morphology overall agreement; Platelet estimation correlation; Platelet estimation efficiency; Platelet estimation sensitivity; Platelet estimation specificity

Bench

n=1,200 scans · 1 site(s)

endpoints: repeatability (SD and %CV)

standards: CLSI's EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition

Bench

n=750 scans · 3 site(s)

endpoints: reproducibility (SD and %CV)

standards: CLSI's EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition

Reported performance (4 observations)

sensitivity0.8786CI 85.38% to 90.06%
source quote (p.8)
“87.86% (85.38% to 90.06%)”
specificity0.9762CI 97.16% to 98.02%
source quote (p.8)
“97.62% (97.16% to 98.02%)”
sensitivityas written: “Platelet Estimation Sensitivity”0.9CI 83.51% to 94.57%
source quote (p.10)
“90.00% (83.51% to 94.57%)”
specificityas written: “Platelet Estimation Specificity”0.9628CI 94.11% to 97.82%
source quote (p.10)
“96.28% (94.11% to 97.82%)”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

1
recalls in product code, 24mo
1
MAUDE reports in code, 12mo
-40%
vs code's own 3-yr baseline
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243144 (decision 2025-06-27) from Scopio Labs , Ltd. for a matching device line ("X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243144

  • recall_reason_pattern

    Software/algorithm-related recall in product code JOY (Cellavision AB Forskningsbyn Ideon Scheelevagen 19a Lund Sweden, initiated 2025-10-08): "Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97835

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Hematology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K201301