FibriCheck

K173872

Qompium nv · cleared 2018-09-28 · product code DXH · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“FibriCheck is medical device software that determines heart rhythm conditions, with a primarily focus on the detection of Atrial Fibrillation. It makes use of optical sensing from a mobile device to collect photoplethysmogram data (PPG data).”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=223 patients

endpoints: sensitivity; specificity; positive predictive value; negative predictive value; accuracy

standards: AAMI/ANSI/IEC 62304:2006, ANSI/AAMI/IEC 60601-1-8:2006 and A1:2012, IEC 62366-1:2015

Reported performance (5 observations)

sensitivity0.956
source quote (p.8)
“The diagnostic results yielded in a sensitivity/specificity/positive predictive value/negative predictive value and accuracy for FibriCheck of 95.60%/96.55%/95.60%/96.55%/96.14%”
specificity0.9655
source quote (p.8)
“The diagnostic results yielded in a sensitivity/specificity/positive predictive value/negative predictive value and accuracy for FibriCheck of 95.60%/96.55%/95.60%/96.55%/96.14%”
ppvas written: “positive predictive value”0.956
source quote (p.8)
“The diagnostic results yielded in a sensitivity/specificity/positive predictive value/negative predictive value and accuracy for FibriCheck of 95.60%/96.55%/95.60%/96.55%/96.14%”
npvas written: “negative predictive value”0.9655
source quote (p.8)
“The diagnostic results yielded in a sensitivity/specificity/positive predictive value/negative predictive value and accuracy for FibriCheck of 95.60%/96.55%/95.60%/96.55%/96.14%”
accuracy0.9614
source quote (p.8)
“The diagnostic results yielded in a sensitivity/specificity/positive predictive value/negative predictive value and accuracy for FibriCheck of 95.60%/96.55%/95.60%/96.55%/96.14%”

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
28
MAUDE reports in code, 12mo
+950%
vs code's own 3-yr baseline
2
drift signals on this device
  • adverse_event_inflection

    MAUDE adverse-event reports for product code DXH: 28 in the 12 months ending 2026-06, vs a 2.7/12mo average over the prior 3 windows (+950%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=DXH

  • recall_reason_pattern

    Software/algorithm-related recall in product code DXH (GE Medical Systems China Co., Ltd. No. 19 Changjiang Road Development Zone National Hi-Tech Xin District Wuxi China, initiated 2026-04-21): "Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98917

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 Cardiovascular 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/K173872