# K131189: Unicel DXC Synchron Systems Glucose Reagent (Gluh)

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Apr 17, 2014 after 356 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 K883181 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883181: Synchron CX4/CX5 Clinical Chemistry Analyzer Reage, Beckman Instruments, Inc. (1988) Summary page 1.

## Indications for use
UniCel DxC SYNCHRON Systems Glucose Reagent (GLUH), when used in conjunction with UniCel DxC 600/800 SYNCHRON System(s) and SYNCHRON Systems AQUA CAL 1 and 3, is intended for the quantitative determination of glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF). Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K131189
Methodology: https://510kreport.com/methodology