ACR LAB Urine Analysis Test System

K182384

Healthy.io Ltd · cleared 2019-07-26 · product code JFY · Clinical Chemistry

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The ACR | LAB Urine Analysis Test System also consists of a smartphone application for use on iPhone 7 device (iOS 12), and an image recognition algorithm running on the Backend¹.”
Algorithmimage recognition algorithm
source quote (p.5)
“The ACR | LAB Urine Analysis Test System also consists of a smartphone application for use on iPhone 7 device (iOS 12), and an image recognition algorithm running on the Backend¹.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.10)
“In accordance with the FDA's guidance for management of cyber-security in medical devices, the OCR's HIPAA regulation and ISO 27001:2013, Healthy.io conducted a comprehensive hazard analysis. The cyber security analysis report, together with the cyber security validation test report summarizes the assessment process for cyber security and demonstrates that the software meets the required level of cyber security protection.”

Validation studies (7)

Bench

n=1,080 cases · 3 site(s)

endpoints: percent of exact match

standards: CLSI EP05-A3

Bench

sample size not stated

endpoints: lowest concentration level that causes interference

standards: CLSI EP07, CLSI EP37

Bench

sample size not stated

endpoints: lowest concentration at which >55% of the results were positive

standards: CLSI EP17-A2

Bench

sample size not stated

endpoints: direct proportionality to analyte concentrations

standards: CLSI EP6-A

Bench

sample size not stated

endpoints: impact of timing on measurement accuracy

Bench

sample size not stated

endpoints: device stability and accurate measurements under various conditions

Retrospective clinical

n=375 patients · 3 site(s)

endpoints: percent of exact match; ±1 color block match

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

0
recalls in product code, 24mo
58
MAUDE reports in code, 12mo
+60%
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 Clinical Chemistry 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/K182384