# K973140: Duet Glucose Control Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Lxn Corp.
- Decided: Oct 31, 1997 after 71 days
- Product code: CGA (Glucose Oxidase, 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The DUET™ Glucose Control Monitoring System is intended for the quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens. The DUET Fructosamine Test System is intended for use by people with diabetes to monitor their blood glucose and fructosamine levels in a home use setting. This in vitro test kit is intended for home use (over the counter).

Source page: https://510kreport.com/device/K973140
Methodology: https://510kreport.com/methodology