# K101854: Advia Chemistry Glucose Hexokinase_3 (Gluh_3) Reagent, Models Ref 05001429

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Mar 7, 2011 after 249 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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 K042015 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042015: Advia Chemistry Glucose Oxidase Assay and Advia Chemistry Glucose Hexokinase, Bayer Healthcare, Diagnostics Division (2004) Summary page 1.

## Most influential descendants
- K120681: Advia Chemistry Gluh_3 Reagents (2012), 0 descendants of its own

## Indications for use
For in vitro diagnostic use in the quantitative determination of glucose in human serum, plasma, urine and CSF on the ADVIA 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, idiopathic hypoglycemia, and insulin overdose.

Source page: https://510kreport.com/device/K101854
Methodology: https://510kreport.com/methodology