Minuteful - kidney test

Basic Information

• Brand Name: Minuteful - kidney test
• Primary DI: 17290017272471
• Version / Model: MNT KDN.US.GEN
• Company Name: HEALTHY.IO LTD
• Labeler DUNS: 600437232
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-01
• Public Version: 1
• Public Version Date: 2022-11-09
• Public Version Status: New
• Public Device Record Key: 3f04a475-2f9e-4271-a614-d47f06c0fbcf

Device Description

The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR), with results that are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	862.1645	1
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	862.1225	2
KQO	Automated Urinalysis System	Clinical Chemistry	862.2900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65242	Self-testing data clinician presentation application software IVD	An application software program designed as an Internet-based information system intended to be used by a healthcare professional to view the results of a self-test [e.g., immunochromatographic test (ICT)] performed by a patient. The software receives data from the patient’s mobile device (e.g., smartphone) application software, through a web portal, and presents the results to the healthcare professional for review and assessment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17290017272471	GS1

Premarket Submissions

Submission Number	Supplement Number
K210069	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit