DIP/U.S. Urine Analysis Test System

K173327

Healthy.io Ltd · cleared 2018-07-18 · product code JIL · Clinical Chemistry

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“The DIP | U.S. Urine Analysis Test System consists of a smartphone application, a proprietary Color-Board, and Urinalysis Reagent Strips. It is intended for the semi-quantitative detection of the following analytes in urine: Glucose, Specific Gravity, Blood, pH and Protein, as well as the qualitative detection of Nitrite. The DIP | U.S. Urine Analysis Test System also consists of a smartphone application for use with a LG Nexus 5 device (running operating system Lollipop 5.0), and an image recognition algorithm running on the back-end.”
Algorithmimage recognition algorithm running on the back-end
source quote (p.6)
“The DIP | U.S. Urine Analysis Test System also consists of a smartphone application for use with a LG Nexus 5 device (running operating system Lollipop 5.0), and an image recognition algorithm running on the back-end.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.13)
“In accordance with the FDA's guidance for management of cyber-security in medical device, the OCR's HIPAA regulation and ISO 27001, 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 (10)

Bench

n=360 other · 3 site(s)

endpoints: exact match

standards: CLSI EP05-A3

Bench

n=1,080 other · 3 site(s)

endpoints: exact match

standards: CLSI EP05-A3

Bench

sample size not stated

endpoints: lowest concentration level that causes interference

standards: CLSI EP7-A2

Bench

sample size not stated

endpoints: ability to accurately detect the limits concentration of every analyte

standards: CLSI EP17-A2

Bench

sample size not stated

endpoints: exact match; +-1 color block accuracy

standards: CLSI EP6-A

Bench

sample size not stated

endpoints: performance over time under the influence of environmental factors such as temperature and humidity; shelf life and recommended storage conditions

standards: IEC TR 60721-4-1:2001+A1:03 Class 1K2, IEC TR 60721-4-1:2001+A1:03 Class 1M2

Bench

sample size not stated

endpoints: exact match

Bench

sample size not stated

endpoints: exact match

Retrospective clinical

n=429 patients · 2 site(s)

endpoints: percent exact match; ±1 color block match

standards: CLSI EP9-A2

Retrospective clinical

n=250 patients · 1 site(s)

endpoints: degree of agreement with the predicate device

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
20
MAUDE reports in code, 12mo
+25%
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/K173327