# K032791: Glycohemosure HBA1C Control

- Pathway: 510(k) (Traditional)
- Applicant: Quantimetrix Corp.
- Decided: Oct 30, 2003 after 52 days
- Product code: GGM (Control, Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.8625
- 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. The FDA summary names its predicate without a number.
- (no number) Lyphochek Diabetes Control: named in the summary without a submission number

## Most influential descendants
- K043070: Liquid Stable HBA1C Control (2004), 0 descendants of its own

## Indications for use
The Quantimetrix GlycoHemosure is intended for the quality control of laboratory procedures for the quantitation of HbAlc.

Source page: https://510kreport.com/device/K032791
Methodology: https://510kreport.com/methodology