DeviceClearance

Product code NOZ— Hematology

Diazyme 1,5-AG Assay

Classification name
Assay, 1,5-Anhydroglucitol (15ag)
Device class
Class 2
Regulation
21 CFR 864.7470
Advisory panel
Hematology
Total cleared
2
First cleared
Most recent

FDA classification definition

“The test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in patient's blood. The test is for professional use, and is indicated for the monitoring of glycemic control in people with diabetes.”

— U.S. Food and Drug Administration, device classification record for product code NOZ under 21 CFR 864.7470, via openFDA

Market context for product code NOZ

FDA has cleared 2 devices under product code NOZ between 2003 and 2018, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NOZ

Recent clearances under product code NOZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.