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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K222921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210069000Minuteful - kidney testHealthy.Io, Ltd.2022-07-06JIR
K222921000Minuteful-kidney testHealthy.Io, Ltd.2023-09-08JIR

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 Temperature00

Regulatory Flags#

DUNS number
600437232
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277664395MEDLINEMEDLINE INDUSTRIES, INC.KQO2026-10-01
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JFY2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JFY2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.KQO2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JIR2026-06-26
06972164410008LOOKEE® AscleTrack™ Urine Test AnalyzerKunming Lianen Biotechnology Co., LTDKQO2026-06-26
06972164410022LOOKEE® AscleTrack™ Urine Microalbumin (MAU) Test StripKunming Lianen Biotechnology Co., LTDJIR2026-06-26
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.KQO2026-06-03