Clinical Chemistry · 510(k) · 2018
DIP/U.S. Urine Analysis Test System
Healthy.io Ltd. Cleared by FDA on 18 July 2018 under submission K173327, product code JIL (method, enzymatic, glucose (urinary, non-quantitative)). What FDA's record says, in FDA's words.
Device record · K173327
- Device. DIP/U.S. Urine Analysis Test SystemDEVICE
- Company. Healthy.io Ltd (IL)COMPANY
- Decision. 18 July 2018, 510(k), substantially equivalent (traditional review); received 20 October 2017DECISION
- Panel. Clinical ChemistryPANEL
- Product code. JIL, Method, Enzymatic, Glucose (Urinary, Non-Quantitative)CODE
- Regulation. 21 CFR 862.1340, Class IIREG
- Source. FDA database entry · decision document (13 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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 is intended for prescription home-use only, with results provided directly to the physician. The results can be used to guide patient management and care, and aid in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function and endocrine disorders. Physician interpretation of the results should be made in conjunction with the patient’s other clinical information to determine if further confirmatory tests or consultations are necessary. Patients do not have access to the results at any point in the process.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 609 reports filed against devices carrying product code JIL. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · MEDLINE · Medline Industries, LP · report 1417592-2026-55065
29 September 2026 · Malfunction · MEDLINE · Medline Industries, LP · report 1417592-2026-52861
It was reported that "ITEM IS ASKING FOR A CANISTER CODE AND WHEN THE CUSTOMER INPUTS THE REQUESTED CODE, IT COMES BACK WITH AN ERROR."
29 September 2026 · Malfunction · MEDLINE · Medline Industries, LP · report 1417592-2026-53127
29 September 2026 · Malfunction · MEDLINE · Medline Industries, LP · report 1417592-2026-53835
28 September 2026 · Malfunction · MEDLINE · Medline Industries, LP · report 1417592-2026-52064
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code JIL, in Clinical Chemistry, from Healthy.io Ltd, or cleared in 2018. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.