X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application

K220013

Scopio Labs Ltd. · cleared 2022-05-03 · product code JOY · Hematology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.3)
“The X100HT with Full Field Peripheral Blood Smear (PBS) Application is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.Cell images are analyzed 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.7)
“Cell images are analyzed using standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells.”
Adaptive (vs locked)No
source quote (p.6)
“the analysis information provided by both devices uses the identical technology that was originally 510(k)-cleared and must be interpreted and confirmed or adjusted by the trained user.”
PCCPFDA source did not state this
Cybersecurity addressedNo

Validation studies (0)

FDA source did not describe a validation study.

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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
1
drift signals on this device
  • 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/K220013