FDA.reportPublic FDA data

Assure® Titanium Blood Glucose Test Strips

Primary DI
00015482600501
Brand
Assure® Titanium Blood Glucose Test Strips
Company
ARKRAY USA, INC.
Model
600050
Device description
The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposable single-use Assure Titanium Blood Glucose Test Strips, Assure Control-Control Solutions (Level 1, 2 and Level 3), Quick Reference Guide and User Manual. Assure Titanium Blood Glucose Test Strips and Assure Control-Control Solutions are not included in the kit package and should be purchased separately.
Published
2025-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PZIPrescription Use Blood Glucose Meter For Near-Patient Testing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZIPrescription Use Blood Glucose Meter For Near-Patient TestingClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200788000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200788000Assure Titanium Blood Glucose Monitoring SystemArkray, Inc.2022-05-23PZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10015482600508PackageGS112In Commercial Distribution
20015482600505PackageGS118In Commercial Distribution
00015482600501PrimaryGS10
50015482600506Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001548260050810015482600508
2001548260050520015482600505
00015482600501000154826005010154826005010015482600501
5001548260050650015482600506

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, point-of-careA collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature46 Degrees Fahrenheit86 Degrees Fahrenheit
Special Storage Condition, Specify00Avoid storing test strips in direct sunlight.
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
800-818-8877xx@xx.xx

Regulatory Flags#

DUNS number
008171162
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987486009801AUTION Check Plus Controls1024782020-02-26
04987486001959S.G. Calibrator H1006722017-04-12
04987486053002S.G. Calibrator H111581N/A2025-12-19
00015482104658AUTION MAX™ AX-4060 Analyzer1005262025-11-07
00015482510060Assure® Control - Control Solution Level 2 & Level 35100062025-09-26
00015482601003Assure® Titanium Blood Glucose Test Strips6001002025-09-15
00015482600013Assure® Titanium Blood Glucose Meter6000012025-09-15
10015482600508Assure® Titanium Blood Glucose Test Strips6000502025-09-15
10015482601000Assure® Titanium Blood Glucose Test Strips6001002025-09-15
00015482510046Assure® Control - Control Solution Level 15100042019-04-01
00015482510053Assure® Control - Control Solution Level 25100052019-04-01
00015482510077Assure® Control - Control Solution Level 35100072019-04-01
00015482102913ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
00015482102951ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
00015482511104GLUCOCARD® W Blood Glucose Monitoring System 5111002019-04-01
00015482512057GLUCOCARD® W Blood Glucose Test Strips5120502019-04-01
10015482102910ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
10015482102958ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
30015482501779Assure® Platinum Blood Glucose Meter5011772022-06-17
30015482531776Assure® Prism Multi Blood Glucose Meter5311772022-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385480657365StatSensor StatStripNOVA BIOMEDICAL CORPORATIONPZI2026-05-06
00385480667678StatSensor StatStripNOVA BIOMEDICAL CORPORATIONPZI2026-05-06
00385480667685StatSensor StatStripNOVA BIOMEDICAL CORPORATIONPZI2026-05-06
00015482601003Assure® Titanium Blood Glucose Test StripsARKRAY USA, INC.PZI2025-09-15
00015482600013Assure® Titanium Blood Glucose MeterARKRAY USA, INC.PZI2025-09-15
10015482600508Assure® Titanium Blood Glucose Test StripsARKRAY USA, INC.PZI2025-09-15
10015482601000Assure® Titanium Blood Glucose Test StripsARKRAY USA, INC.PZI2025-09-15
00385480636858StatStripNOVA BIOMEDICAL CORPORATIONPZI2024-03-28
00385480533980STATSTRIPNOVA BIOMEDICAL CORPORATIONPZI2016-09-20
00385480533997STATSTRIPNOVA BIOMEDICAL CORPORATIONPZI2016-09-20
00385480547901STATSTRIPNOVA BIOMEDICAL CORPORATIONPZI2016-09-16