# K180356: inui In-Home Urine Analysis Test System

- Pathway: 510(k) (Traditional)
- Applicant: Scanadu, Inc.
- Decided: May 25, 2018 after 106 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: 1 generation back to K992257 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992257: New Multiples Reagent Strips, Bayer Corp. (1999) Summary page 4.

## Indications for use
The inui In-Home Urine Analysis Test System consists of the inui In-Home Urine Analysis Device and the inui Urine Analysis Mobile Application. The inui In-Home Urine Analysis Test System is intended for detecting the following parameters in urine: Protein, Glucose, Leukocytes, Nitrites, and Ketones. The test results provide information regarding the status of Urinary Tract Infections (UTI), proteinuria, glucosuria, and ketonuria. These results can be used as an aid for monitoring kidney functions and metabolic disorders (e.g. diabetes mellitus), and can be used in the screening for Urinary Tract Infections (UTI). The inui In-Home Urine Analysis Device is intended for use as a prescription home use device.

Source page: https://510kreport.com/device/K180356
Methodology: https://510kreport.com/methodology