FDA.reportPublic FDA data

TRUEtrack

Primary DI
00021292008888
Brand
TRUEtrack
Company
TRIVIDIA HEALTH, INC.
Model
TRUEtrack 25 Blood Glucose Test Strips
Device description
TRUEtrack 25 Blood Glucose Test Strips
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032657000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032657000TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)Home Diagnostics, Inc.2004-03-24NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00010939264442PackageGS11Not in Commercial Distribution
00011822359870PackageGS11In Commercial Distribution
00021292002930PackageGS11In Commercial Distribution
00041220660803PackageGS11Not in Commercial Distribution
00041415050785PackageGS11Not in Commercial Distribution
00050428288870PackageGS11In Commercial Distribution
00050428421734PackageGS11In Commercial Distribution
00311917104881PackageGS11Not in Commercial Distribution
10010939264449PackageGS124Not in Commercial Distribution
10011822359877PackageGS124In Commercial Distribution
10021292002937PackageGS124In Commercial Distribution
10041220660800PackageGS124Not in Commercial Distribution
10041415050782PackageGS124Not in Commercial Distribution
10050428288877PackageGS124In Commercial Distribution
10050428421731PackageGS124In Commercial Distribution
10311917104888PackageGS124Not in Commercial Distribution
00021292008888PrimaryGS10
00021292007751Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00010939264442000109392644420109392644420010939264442
00011822359870000118223598700118223598700011822359870
00021292002930000212920029300212920029300021292002930
00041220660803000412206608030412206608030041220660803
00041415050785000414150507850414150507850041415050785
00050428288870000504282888700504282888700050428288870
00050428421734000504284217340504284217340050428421734
00311917104881003119171048813119171048810311917104881
1001093926444910010939264449
1001182235987710011822359877
1002129200293710021292002937
1004122066080010041220660800
1004141505078210041415050782
1005042828887710050428288877
1005042842173110050428421731
1031191710488810311917104888
00021292008888000212920088880212920088880021292008888
00021292007751000212920077510212920077510021292007751

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature40 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)803-6025customercare@trividiahealth.com

Regulatory Flags#

DUNS number
151810868
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428167243TRUEplusCVS TRUEplus 5-bevel Pen Needle 31G 5mm - 50ct - nS6007B31-502026-10-07
00050428167267TRUEplusTRUEplus 5-bevel Pen Needle 32G 4mmS6007A32-502026-10-07
00050428167281TRUEplusTRUEplus Sterile LancetsS1007DB30-1002026-08-14
00050428167298TRUEdrawCVS TRUEdraw Lancing DeviceS3007-012026-08-14
00050428167304TRUEplusTRUEplus Sterile LancetsS1007LB28-1002026-08-14
00050428167311TRUEplusTRUEplus Sterile LancetsS1007YL33-1002026-08-14
00050428167328TRUEplusTRUEplus Sterile LancetsS1007DB30-2002026-08-14
00050428167380TRUEplusTRUEplus Sterile LancetsS1007YL33-2002026-08-14
00050428324073TRUEplusTRUEplus 5-bevel Pen Needle 32G 4mmS6007A32-1002026-03-17
10050428324070TRUEplusTRUEplus 5-bevel Pen Needle 32G 4mmS6007A32-1002026-03-17
00041260007354TRUE METRIX AIRTRUE METRIX AIR Self Monitoring Blood Glucose MeteREA4203-012026-02-09
10041260007351TRUE METRIX AIRTRUE METRIX AIR Self Monitoring Blood Glucose MeteREA4203-012026-02-09
00021292015381TRUE METRIX PROTRUE METRIX PRO Professional Blood Glucose Monitor2025-12-02
10840330705698TRUE METRIX PROTRUE METRIX PRO Professional Blood Glucose Monitor2025-12-02
00075450843576TRUE METRIX GOTRUE METRIX GO Self-Monitoring Blood Glucose MeterRF4048-012025-11-26
10075450843573TRUE METRIX GOTRUE METRIX GO Self-Monitoring Blood Glucose MeterRF4048-012025-11-26
10840330706541TRUE METRIXTRUE METRIX Control Solution - Level 1 and Level 3R5212-132025-11-25
30840330706545TRUE METRIXTRUE METRIX Control Solution - Level 1 and Level 3R5212-132025-11-25
00021292009120TRUE METRIXTRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STR2016-09-24
00021292007256TRUE METRIXTRUE METRIX SELF MONITORING BLOOD GLUCOSE METER RE4023-012016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810227730167Fort Worth DiagnosticsFort Worth Diagnostics, LLCJJX2026-10-27
00810227730174Fort Worth DiagnosticsFort Worth Diagnostics, LLCJJX2026-10-27
00810227730181Fort Worth DiagnosticsFort Worth Diagnostics, LLCJJX2026-10-27
00850070979375FondCircleFondCircle Inc.NBW2026-10-27
00850070979344FondCircleFondCircle Inc.NBW2026-10-26
00850070979351FondCircleFondCircle Inc.NBW2026-10-26
00850070979368FondCircleFondCircle Inc.NBW2026-10-26
00850011135921AccuTrakLgc Clinical Diagnostics, Inc.JJX2026-10-15
10758750035823VITROSORTHO CLINICAL DIAGNOSTICSJJX2026-08-26
00850011135884VALIDATELgc Clinical Diagnostics, Inc.JJX2026-08-25
04719869706966medisana BG 150 Blood Glucose MeterTYSON BIORESEARCH INC.NBW2026-08-19
04719869707000BG 150 Control SolutionTYSON BIORESEARCH INC.NBW2026-08-19
04719869707017BG 150 Control SolutionTYSON BIORESEARCH INC.NBW2026-08-19
04719869707024BG 150 Blood Glucose Test Strip(50T)TYSON BIORESEARCH INC.NBW2026-08-19
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCCGA2026-08-13
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCJJX2026-08-13
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCNBW2026-08-13
00682607551354ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551361ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551378ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815234ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00682607551392ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551408ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551422ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551439ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30