# K042015: Advia Chemistry Glucose Oxidase Assay and Advia Chemistry Glucose Hexokinase

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, Diagnostics Division
- Decided: Sep 29, 2004 after 64 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) Roche Glucose Hexokinase: named in the summary without a submission number

## Most influential descendants
- K101854: Advia Chemistry Glucose Hexokinase_3 (Gluh_3) Reagent, Models Ref 05001429 (2011), 1 descendant of its own
- K120681: Advia Chemistry Gluh_3 Reagents (2012), 0 descendants of its own

## Recalls of this device
- Mar 17, 2016 · Class II · Z-1655-2016: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depre

## Indications for use
The Bayer ADVIA® 1650 Glucose Hexokinase II assay is an in vitro diagnostic device for use in the quantitative determination of glucose in human cerebrospinal fluid (CSF), serum, plasma (lithium heparin), and urine on the ADVIA® 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose. The Bayer ADVIA® 1650 Glucose Oxidase assay is an in vitro diagnostic device for use in the quantitative determination of glucose in human cerebrospinal fluid (CSF), serum, plasma and urine on the ADVIA® 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.

Source page: https://510kreport.com/device/K042015
Methodology: https://510kreport.com/methodology