# K121752: Avie Total HB Test System

- Pathway: 510(k) (Traditional)
- Applicant: Mec Dynamics Corp
- Decided: Jan 7, 2013 after 207 days
- Product code: GKR (System, Hemoglobin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5620
- 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 K041234 (2004). 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)
- K041234: Hemocue Hemoglobin 201DM Analyzing System, Hemocue, Inc. (2004) Summary page 2.

## Indications for use
The AvieTM Total Hb Test System is for the quantitative measurement of total hemoglobin in whole blood (capillary or venous EDTA, K2). The test system is designed for point-of-care use in primary care settings. The test system is for professional in vitro diagnostic use only.

Source page: https://510kreport.com/device/K121752
Methodology: https://510kreport.com/methodology