A1CNow Self Check, 8ct.

Basic Information

• Brand Name: A1CNow Self Check, 8ct.
• Primary DI: 00381933080018
• Version / Model: 3080
• Catalog Number: 3080
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Labeler DUNS: 835772872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 8
• Record Status: Published
• Publish Date: 2023-10-25
• Public Version: 1
• Public Version Date: 2023-11-02
• Public Version Status: New
• Public Device Record Key: 44b0bbed-15e8-471c-9cc9-7e184c0b690a

Device Description

The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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
LCP	ASSAY, GLYCOSYLATED HEMOGLOBIN	Hematology	864.7470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62205	Glycated haemoglobin (HbA1c) monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c) 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. The measurement is typically based on an immunological method (e.g., immunoassay) and/or spectrophotometry, and is used to evaluate the long-term control of blood glucose concentration, primarily in persons with diabetes mellitus.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10381933080015	GS1
Primary	00381933080018	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090413	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight Keep dry
• Type: Storage Environment Temperature
• Temperature Range: 18 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 64 – 77 Degrees Fahrenheit