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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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 Temperature00
Special Storage Condition, Specify00Avoid storing test strips in direct sunlight.
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
008171162
Device count
50
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
00015482000011ARK Care®Version 2.5.3.2016-09-23
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00015482100032Assure® Slide Pill Swallowing Aid zero10000032018-12-28
00015482102913ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
00015482102951ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
00015482104658AUTION MAX™ AX-4060 Analyzer1005262025-11-07
00015482129743AUTION™ MAX AX-4022 Analyzer1029742017-02-03
00015482230296TechLITE PEN NEEDLES2301292016-09-23
00015482230326TechLITE Pen Needle 4mm x 32g Sample 10's2340322018-02-26
00015482230999TechLITE PEN NEEDLES2309292016-09-23
00015482232290TechLITE PEN NEEDLES2321292016-09-23
00015482232993TechLITE PEN NEEDLES2329292016-09-23
00015482234232TechLITE PLUS PEN NEEDLES2342322024-03-11
00015482234324TechLITE PEN NEEDLES2341322016-09-23
00015482234928TechLITE PEN NEEDLES2349322016-09-23
00015482235314TechLITE PEN NEEDLES2351312019-05-14
00015482235918TechLITE PEN NEEDLES2359312016-09-23
00015482236311TechLITE PEN NEEDLES2361312016-09-23
00015482236328TechLITE PEN NEEDLES2361322016-09-23
00015482238315TechLITE PEN NEEDLES2381312016-09-23

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