# K120681: Advia Chemistry Gluh_3 Reagents

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: May 15, 2012 after 70 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: 2 generations back to K042015 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101854: Advia Chemistry Glucose Hexokinase_3 (Gluh_3) Reagent, Models Ref 05001429, Siemens Healthcare Diagnostics (2011) Summary page 1.

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

Source page: https://510kreport.com/device/K120681
Methodology: https://510kreport.com/methodology