# K102751: Labonacheck Gluppy Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Ceragem Medisys, Inc.
- Decided: Feb 11, 2013 after 872 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: 5 generations back to K024194 (2003). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081451: Rightest Blood Glucose Monitoring System, Model GM100, Bionime Corporation (2008) Summary page 1.

## Most influential descendants
- K140141: Labonacheck Gluppy Blood Glucose Monitoring System (2014), 0 descendants of its own

## Indications for use
The LabonaCheck Gluppy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The LabonaCheck Gluppy Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The LabonaCheck Gluppy Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The LabonaCheck Gluppy Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The LabonaCheck Gluppy Blood Glucose Test Strips are for use with the LabonaCheck Gluppy Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The LabonaCheck Gluppy Control Solution is for use with the LabonaCheck Gluppy Blood Glucose Monitoring System as a quality control check to verify that the meter and test strips are working together properly.

Source page: https://510kreport.com/device/K102751
Methodology: https://510kreport.com/methodology