# K031604: Glycomark

- Pathway: 510(k) (Traditional)
- Applicant: Tomen America, Inc.
- Decided: Sep 22, 2003 after 123 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: 1 generation back to K934070 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934070: Tina-Quant Hemoglobin A1C, Boehringer Mannheim Corp. (1994) Summary page 1.

## Most influential descendants
- K180209: Diazyme 1,5-AG Assay (2018), 0 descendants of its own

## Indications for use
The GlycoMarkTMtest provides quantitative measurement of 1,s-anhydroglucitol (1 SAG) in serum or plasma. The test is for professional use, and is indicated for the intermediate term monitoring of glycemic control in people with diabetes.

Source page: https://510kreport.com/device/K031604
Methodology: https://510kreport.com/methodology