FDA.reportPublic FDA data

KetoSens

Primary DI
10885325001492
Brand
KetoSens
Company
i-SENS, Inc.
Model
276265
Device description
KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10)
Published
2020-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JINNitroprusside, Ketones (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201551000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201551000KetoSens BT Blood B-Ketone Monitoring SystemI-Sens, Inc.2020-09-09JIN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885325001492PackageGS170In Commercial Distribution
00885325001495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088532500149210885325001492
00885325001495008853250014958853250014950885325001495

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyte monitoring system IVD, home-useA collection of devices including a portable, electrically-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used together for the quantitative measurement of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. It is intended to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature39 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-429-5001cs1@i-sens.com

Regulatory Flags#

DUNS number
688840958
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
00885325000856KetoSens276261-2012020-11-10
00885325001495KetoSens2762652020-11-10
10885325000853KetoSens276261-2012020-11-10
00885325001181CareSens S Fit BT1645092023-07-11
00885325001761CareSens N Voice Square1645022023-07-11
10885325001188CareSens S Fit BT1645092023-07-11
00885325001518CareSens S Fit1645062023-07-11
10885325001768CareSens N Voice Square1645022023-07-11
00194631000055Tempo3430042023-01-26
00810011730045TempoPGUHA-00000332023-01-26
00810011730069TempoPGUHA-00000392023-01-26
00875011006712Greater Goods Essential6712023-01-26
00875011006767Greater Goods Essential6762023-01-26
00885325000542CareSensPGUHA-00000022023-01-26
00885325000924CareSensPGUHA-00000032023-01-26
00885325001556CareSensPGUHA-00000602023-01-26
00885325001716CareSoft1640062023-01-26
00885325001778CareSens N Feliz1645072023-01-26
00885325001785CareSens N1641052023-01-26
00885325000023CareSens N164104-203164104-203, 164104-2052016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
00816042016417FORAFORA CARE INC.JIN2026-03-20
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
04710469879548XPER Technology Multi-Functional Monitoring System Procheck SmartTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
04710469879555XPER Technology Multi-Functional Monitoring System Procheck WittyTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
04719893233841XPER Technology Procheck Witty Procheck Smart B-Ketone Test StripsTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
00850014861681heartscare B-Ketone Test Strips (10pcs/Box)Hearts Bio, Inc.JIN2025-10-01
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
00850014861575HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.JIN2025-07-02
00850014861056HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.JIN2025-03-31
00816042015199FORAFORA CARE INC.JIN2025-03-14
00850054026729QMedix™Diagnostic Automation, Inc.JIN2024-10-29
00816042015069FORAFORA CARE INC.JIN2024-10-01
00816042015076FORAFORA CARE INC.JIN2024-10-01
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIN2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-05