# K981185: GLU

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 7, 1998 after 35 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 K812303 (1981). 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)
- K953847: Roche Reagent for Glucose, Roche Diagnostic Systems, Inc. (1996) Summary page 2.
- K812303: Glucose-HK System Pack Test, Boehringer Mannheim Corp. (1981) Summary page 2.

## Indications for use
The Glucose assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the ALCYON 300/300i Analyzer. 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/K981185
Methodology: https://510kreport.com/methodology