FDA.reportPublic FDA data

Minuteful - kidney test

Primary DI
17290017272471
Brand
Minuteful - kidney test
Company
HEALTHY.IO LTD
Model
MNT KDN.US.GEN
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.
Published
2022-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JFYEnzymatic Method, Creatinine
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
KQOAutomated Urinalysis System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFYEnzymatic Method, CreatinineClinical Chemistry2
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1
KQOAutomated Urinalysis SystemClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210069000Minuteful - kidney testHealthy.Io, Ltd.2022-07-06JIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017272471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729001727247117290017272471

GMDN Terms#

Term, Definition table
TermDefinition
Self-testing data clinician presentation application software IVDAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Regulatory Flags#

DUNS number
600437232
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290017272716Minuteful for WoundMNT WND.EN.GN22024-03-01
17290017272877Minuteful for Wound at HomeWND PNT.EN.GEN2024-03-01
17290017272556SPOTSPOT.EN.G252022-01-17
17290017272709Minuteful for WoundMNT WND.EN.GEN2022-09-15
17290017272501SPOTSPOT.EN.GEN2020-08-25
07290017272504SPOTSPOT.EN.G252022-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.KQO2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIR2025-09-18
10884389181942MEDLINEMEDLINE INDUSTRIES, INC.JIR2025-04-29
16936983168646DrugTect Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JIR2025-02-13
16936983168646DrugTect Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JFY2025-02-13
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSKQO2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSKQO2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIR2024-06-04
00630414631707Clinistix Kidney Health Test SystemSiemens Healthcare Diagnostics Inc.JFY2024-05-03
00630414631707Clinistix Kidney Health Test SystemSiemens Healthcare Diagnostics Inc.JIR2024-05-03
08806141303497One+Step 10ADFI CO.,LTDJIR2023-10-16
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.KQO2023-06-08
00630414610962ADVIA CHEM Ecre3Siemens Healthcare Diagnostics Inc.JFY2022-12-22
00630414610948Atellica CH ECRE3Siemens Healthcare Diagnostics Inc.JFY2022-09-30
10888277677791MedlineMEDLINE INDUSTRIES, INC.JIR2022-08-04
10884389181973MedlineMEDLINE INDUSTRIES, INC.JIR2022-04-13
10884389181959MedlineMEDLINE INDUSTRIES, INC.JIR2021-09-16
00630414607962Clinitek Status ConnectorSiemens Healthcare Diagnostics Inc.JFY2020-09-30