510(k) · Cleared
ClearedDiazyme 1,5-AG Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories, Inc. · NOZ Assay, 1,5-Anhydroglucitol (15ag)
Cleared on Oct 4, 2018 as substantially equivalent to K031604 (Tomen America, Inc., 2003) after a 253-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Oct 4, 2018
- Review
- 253 days
- Class
- Class II
- Product code
- NOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934070 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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
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 | Decided |
|---|---|---|---|
| * | K031604 | GlycomarkSummary page 4…umber 21 CFR 864.7470 Device Class II Predicate Device: GlycoMark™ 1,5-anhydroglucitol (1,5-AG) (k031604). Manufacturing Address Diazyme Laboratories Inc. 12889 Gregg Court… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 15.0 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All NOZ devicesNOZ Assay, 1,5-Anhydroglucitol (15ag): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NOZ
1in 2018
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180209: Diazyme 1,5-AG Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180209
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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