# K081269: Avie A1C Test System

- Pathway: 510(k) (Traditional)
- Applicant: Mec Dynamics Corp
- Decided: Mar 20, 2009 after 319 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- 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 K952720 (1995). 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)
- K041635: G5 I HBA1C Test, G5 II HBA1C Test, Provalis Diagnostics, Ltd. (2004) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K081269
Methodology: https://510kreport.com/methodology