510(k) · Cleared
ClearedAvie A1C Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mec Dynamics Corp · LCP Assay, Glycosylated Hemoglobin
Cleared on Mar 20, 2009 as substantially equivalent to K041635 (Provalis Diagnostics, Ltd., 2004) after a 319-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Mar 20, 2009
- Review
- 319 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952720 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK952720 Aalto Scientific LTD. Glycated Hemoglobin Control Levels I & IIAalto Scientific, Ltd. · 1995 · Recalled
- 1 generation backK041635 G5 I HBA1C Test, G5 II HBA1C TestProvalis Diagnostics, Ltd. · 2004 · Recalled
- This deviceK081269 Avie A1C Test SystemMec Dynamics Corp · 2009
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 LCP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LCP device
- #1 K221326 Nova Allegro HbA1c Assay, Nova Allegro Analyzerscore 9.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K041635 | G5 I HBA1C Test, G5 II HBA1C TestSummary page 1…systems, and specifically, the G5 MI/ FHbAl C Test System (Provalis Diagnostics, Ltd.), most recently cleared under premarket notification K04 1635 on August 16, 2004. 807.92 (a)(4): Device Description The Avie Al C test system is for the quantit… | 2004 |
| † | K051321 | Inview | 2005 |
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 14 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LCP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LCP
269in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCP
22in 2025
MAUDE reports naming product code LCP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 133 | 1 | 5 |
| 2008 | 5 | 206 | 3 | 11 |
| 2009 | 6 | 158 | 6 | 15 |
| 2010 | 2 | — | 5 | 4 |
| 2011 | 10 | 176 | 51 | 27 |
| 2012 | 9 | 143 | 0 | 51 |
| 2013 | 2 | — | 4 | 193 |
| 2014 | 8 | 127 | 2 | 182 |
| 2015 | 3 | 239 | 2 | 64 |
| 2016 | 2 | — | 6 | 29 |
| 2017 | 5 | 218 | 1 | 149 |
| 2018 | 2 | — | 1 | 1,911 |
| 2019 | 4 | 269 | 0 | 114 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 1 | 8 |
| 2023 | 2 | — | 0 | 27 |
| 2024 | 1 | — | 1 | 39 |
| 2025 | 0 | — | 1 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AvieTM Al c test is a point of care system that quantitatively measures %A 1C (glycated hemoglobin) in capillary or venous whole blood samples. The test is for prescription use and physician-directed home use to monitor glycemic control in people with diabetes mellitus. The device cannot be used in patients with hemoglobinopathies of HbF, HbC, and HbD.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081269: Avie A1C Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081269
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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