A1CNow®+ Multi-Use Test System (10 count)

Basic Information

• Brand Name: A1CNow®+ Multi-Use Test System (10 count)
• Primary DI: 00381933024012
• Version / Model: 3024
• Catalog Number: 3024
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Labeler DUNS: 835772872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-08-05
• Public Version: 5
• Public Version Date: 2022-04-14
• Public Version Status: Update
• Public Device Record Key: 6b211703-5905-42a3-970f-62d3d0e4aa9a

Device Description

The A1CNow®+ Multi-Use 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): Yes
• Over the Counter (OTC): No
• 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
62206	Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care	A collection of devices including a portable, electrically-powered, semi-automated or automated instrument (meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen. 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
Primary	00381933024012	GS1
Unit of Use	10381933024019	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: Product may be stored for a total of four months at room temperature (18-25 degrees C) anytime before the expiration date.
• Type: Special Storage Condition, Specify
• Special Conditions: If refrigerated, ensure components are at room temperature prior to use.
• Type: Special Storage Condition, Specify
• Special Conditions: If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
• Type: Storage Environment Temperature
• Temperature Range: 36 – 46 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius