AUTION EYE AI-4510 Urine Particle Analysis System

K232416

Arkray Inc. · cleared 2024-05-03 · product code LKM · Hematology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The AI-4510 System (AUTION EYE AI-4510) is a fully automated urine particle analyzer for in vitro diagnostic use that uses flow cell digital imaging technology in a clinical laboratory setting. Based on images captured in the flow method, the instrument automatically classifies the images of various formed elements. The principle of operation of the AI-4510 System is based on image capture and the digital processing of images for particle analysis and recognition from a locked sorting algorithm for clustering and classification.”
AlgorithmThe principle of operation of the AI-4510 System is based on image capture and the digital processing of images for particle analysis and recognition from a locked sorting algorithm for clustering and classification.
source quote (p.12)
“The principle of operation of the AI-4510 System is based on image capture and the digital processing of images for particle analysis and recognition from a locked sorting algorithm for clustering and classification.”
Adaptive (vs locked)No
source quote (p.12)
“The principle of operation of the AI-4510 System is based on image capture and the digital processing of images for particle analysis and recognition from a locked sorting algorithm for clustering and classification. In addition, the AI-4510 System allows trained operators to manually review and reclassify all the element images collected by the system.”
PCCPNo
Cybersecurity addressedNo

Validation studies (9)

Bench

n=10 other · 1 site(s)

endpoints: repeatability for all twelve (12) elements from low to high concentrations

Bench

sample size not stated

endpoints: measurement imprecision

standards: CLSI EP05-A3

Bench

sample size not stated · 3 site(s)

endpoints: measurement imprecision

standards: CLSI EP05-A3

Bench

sample size not stated · 1 site(s)

endpoints: establish the linear interval for quantitative elements: RBC, WBC, and SQEC

standards: CLSI EP06-2nd Edition

Bench

sample size not stated

endpoints: Limit of Blank (LoB); Limit of Detection (LoD); Limit of Quantitation (LoQ)

standards: CLSI-EP17-A2

Bench

sample size not stated

endpoints: confirm that there are no carryover contaminations for all twelve (12) elements

Bench

sample size not stated

endpoints: evaluate the influence of interfering substances on the measurement of twelve (12) particle elements

Bench

sample size not stated

endpoints: confirm the sample stability of twelve (12) elements

Retrospective clinical

n=1,474 cases · 3 site(s)

endpoints: agreement of urine sample test results between the candidate device, the AI-4510 System, and the FDA-cleared predicate device, the iQ200 System (K093861) and manual microscopy

Reported performance (2 observations)

sensitivity76.2CI 72.9%, 79.3%
source quote (p.22)
“Sensitivity 76.2% (72.9%, 79.3%)”
specificity83.7CI 81.0%, 86.1%
source quote (p.22)
“Specificity 83.7% (81.0%, 86.1%)”

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

0
recalls in product code, 24mo
1
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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/K232416