# K173327: DIP/U.S. Urine Analysis Test System

- Pathway: 510(k) (Traditional)
- Applicant: Healthy.Io, Ltd.
- Decided: Jul 18, 2018 after 271 days
- Product code: JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative))
- Device class: 2
- Regulation: 21 CFR 862.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K905396 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111221: Mission U500 Urine Analyzer, ACON Laboratories, Inc. (2012) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K173327
Methodology: https://510kreport.com/methodology