# K180209: Diazyme 1,5-AG Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories, Inc.
- Decided: Oct 4, 2018 after 253 days
- Product code: NOZ (Assay, 1,5-Anhydroglucitol (15ag))
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934070 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031604: Glycomark, Tomen America, Inc. (2003) Summary page 4.

## Indications for use
Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K180209
Methodology: https://510kreport.com/methodology