Assure® Platinum

Basic Information

• Brand Name: Assure® Platinum
• Primary DI: 00015482502300
• Version / Model: 502030
• Catalog Number: N/A
• Company Name: ARKRAY USA, INC.
• Labeler DUNS: 008171162
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2019-11-25
• Public Version: 1
• Public Version Date: 2019-12-03
• Public Version Status: New
• Public Device Record Key: 9958c918-cdbb-4221-b18c-81e67e362a94

Device Description

Blood Glucose Test Strips. Assure Platinum Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Assure Platinum Blood Glucose Meter. Testing is done outside the body (in vitro diognostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as a aid to monitor the effectiveness of diabetes control.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-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 for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed 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. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00015482502300	GS1
Unit of Use	50015482502305	GS1
Package	10015482502307	GS1	Case Shipper	12	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K092104	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 39 – 86 Degrees Fahrenheit