Advanced RBC Application

K171315

Cella Vision AB · cleared 2017-08-01 · product code JOY · Hematology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“The CellaVision DM1200 with the Advanced RBC Application is an automated cell-locating device, intended for in-vitro diagnostic use. The cell images are pre-characterized into different groups of morphological characteristics based on size, color, shape and inclusion using segmentation, feature calculation and the deterministic artificial neural networks (ANNs) trained to distinguish between morphology characteristics of red blood cells.”
Algorithmdeterministic artificial neural networks (ANNs)
source quote (p.5)
“The cell images are pre-characterized into different groups of morphological characteristics based on size, color, shape and inclusion using segmentation, feature calculation and the deterministic artificial neural networks (ANNs) trained to distinguish between morphology characteristics of red blood cells.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated · 3 site(s)

endpoints: grading reproducibility; proportional cell count in percent; total variance; variance components; grading agreement

standards: CLSI EP05-A3

Retrospective clinical

sample size not stated

endpoints: overall agreement; positive percent agreement (PPA); negative percent agreement (NPA); efficiency; sensitivity; specificity

standards: CLSI H20-A2

Reported performance (2 observations)

agreement_kappaas written: “positive percent agreement (PPA)”stated without value
source quote (p.9)
“The comparison study demonstrates that for the morphology group Size the overall agreement as well as positive percent agreement (PPA) and negative percent agreement (NPA), fulfilled the acceptance criteria for samples run on the DM Systems.”
agreement_kappaas written: “negative percent agreement (NPA)”stated without value
source quote (p.9)
“The comparison study demonstrates that for the morphology group Size the overall agreement as well as positive percent agreement (PPA) and negative percent agreement (NPA), fulfilled the acceptance criteria for samples run on the DM Systems.”

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 matches this device's applicant.

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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Cellavision AB Forskningsbyn Ideon Scheelevagen 19a Lund Sweden) — same firm and product code, not necessarily this device · 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.

    recall event 97835 (openFDA)

  • Recalling firm matches this device's applicant (Cellavision AB Forskningsbyn Ideon Scheelevagen 19a Lund Sweden) — same firm and product code, not necessarily this device · initiated 2017-12-04

    A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.

    recall event 80137 (openFDA)

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/K171315