# K093548: Avie A1C Test System

- Pathway: 510(k) (Traditional)
- Applicant: Mec Dynamics Corp
- Decided: Jul 20, 2011 after 610 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: 1 generation back to K091400 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091400: Modification to Avie A1C Test System, Mec Dynamics Corp (2009) Summary page 1.

## Indications for use
The AvieTM AIC System test is a point of care system that quantitatively measures % AiC (glycated hemoglobin) in capillary and venous whole blood. The AvieTM AIC System consists of the AvieTM AIC System Reader, AvieTM AIC System Test Cartridge and AvieTM AIC System Diluent. The test is for physician directed prescription home use and professional use to monitor glycemic control in patients with diabetes mellitus. Single use, auto-disabling lancing devices are to be used in the professional setting. The device cannot be used in patients with hemoglobinopathies of Hemoglobin C and Hemoglobin D.

Source page: https://510kreport.com/device/K093548
Methodology: https://510kreport.com/methodology