510(k) · Cleared

Cleared

Glycomark

K031604510(k) TraditionalCleared Sep 22, 2003123-day reviewClass II21 CFR 864.7470

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tomen America, Inc. · NOZ Assay, 1,5-Anhydroglucitol (15ag)

Cleared on Sep 22, 2003 as substantially equivalent to K934070 (Boehringer Mannheim Corp., 1994) after a 123-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided: Sep 22, 2003
Review: 123 days
Class: Class II
Product code: NOZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K934070 (1994). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK934070 Tina-Quant Hemoglobin A1CBoehringer Mannheim Corp. · 1994
This deviceK031604 GlycomarkTomen America, Inc. · 2003
Descendant · cites it directly · 0 of its ownK180209 Diazyme 1,5-AG AssayDiazyme Laboratories, Inc. · 2018

Most influential descendants

Showing 1 of 1 · See all

K180209Diazyme 1,5-AG AssayDiazyme Laboratories, Inc. · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934070	Tina-Quant Hemoglobin A1C	Boehringer Mannheim Corp.	1994	—
0 (this device)	K031604	Glycomark	Tomen America, Inc.	2003	—
+1	K180209	Diazyme 1,5-AG Assay	Diazyme Laboratories, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K031604, 1994–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NOZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K934070	Tina-Quant Hemoglobin A1C Summary page 1 …of the legally marketed predicate device GlycoMarkTMis substantially equivalent to existing A1 C assays, namely the Tina- Quant A1 C Assay, K934070 (Roche Diagnostics Corporation, Indianapolis, IN). Both assay systems are indicated for use by people with diabete…	Boehringer Mannheim Corp.	1994	—

Also cleared against K934070: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K180209	Diazyme 1,5-AG Assay	Diazyme Laboratories, Inc.	2018	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K180209 (Diazyme Laboratories, Inc., 2018) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K934070.

How does its category compare?

All NOZ devices

NOZ Assay, 1,5-Anhydroglucitol (15ag): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NOZ

1in 2018

2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NOZ

Too few NOZ 510(k)s in any year since 2007 to give a median.

Recalls per year · NOZ

No recall names NOZ since 2007.

Adverse event reports per year · NOZ

No MAUDE report names NOZ since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031604 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031604: Glycomark.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031604

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026