# K091400: Modification to Avie A1C Test System

- Pathway: 510(k) (Special)
- Applicant: Mec Dynamics Corp
- Decided: Jun 11, 2009 after 30 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K093548: Avie A1C Test System (2011), 0 descendants of its own

## Indications for use
The Avie AIC test is a point of care system that quantitatively measures % AIC (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 patients with diabetes mellitus. The device cannot be used in patients with hemoglobinopathies of HbF, HbC, and HbD.

Source page: https://510kreport.com/device/K091400
Methodology: https://510kreport.com/methodology