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510(k) Data Aggregation
K Number
K180356Device Name
inui In-Home Urine Analysis Test System
Manufacturer
Scanadu, Inc.
Date Cleared
2018-05-25
(106 days)
Product Code
JIL, JIN, JIR, JMT, LJX
Regulation Number
862.1340Why did this record match?
Applicant Name (Manufacturer) :
Scanadu, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 (UT), 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.
Device Description
The inui In-Home Urine Analysis Test System consists of inui In-Home Urine Analysis Device and the inui Urine Analysis Mobile Application. It is an in vitro diagnostic device comprised of a disposable test paddle, a urine collection cup, a gray background sheet, and a mobile application ("inui App"). The plastic "paddle" contains multiple chemistry test pads (CTPs) and 1 quick response (QR) barcode. CTPs contain pre-dried chemicals that react to specific substances in a urine sample. A color reaction occurs on the CTP based on the amount of substance in the urine sample. The color reaction is captured as an image using the mobile device camera and should only be read using the inui App. The results are reported as specified by the measurement range for each test. The QR Code is used for quality control purposes to track lot number, expiration date, and paddle use.
The inui In-Home Urine Analysis System reports semi-quantitative or qualitative results for each test parameters.
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