# K061234: Glucoplus Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Glucoplus, Inc.
- Decided: Oct 30, 2006 after 181 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- 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 K964630 (1997). 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)
- K964630: Glucometer Elite Blood Glucose Meter, Bayer Corp. (1997) Summary page 1.

## Indications for use
The Glucoplus TM Blood Glucose Test System is comrised of Control Solutions and Test Strip biosensors for use only with the Glucoplus Blood Glucose Meter. It is for quantitative measurement of the concentration of glucose in capillary whole blood taken from the fingerstick by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Source page: https://510kreport.com/device/K061234
Methodology: https://510kreport.com/methodology