# K060383: Glucose

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 5, 2006 after 80 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 K953847 (1996). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953847: Roche Reagent for Glucose, Roche Diagnostic Systems, Inc. (1996) Summary page 2.

## Most influential descendants
- K170316: Alinity C Glucose Reagent Kit, Alinity C System (2017), 1 descendant of its own
- K252357: Glucose2 (2025), 0 descendants of its own
- K230790: Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series (2023), 0 descendants of its own

## Indications for use
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K060383
Methodology: https://510kreport.com/methodology