# K090495: Truebalance Blood Glucose System

- Pathway: 510(k) (Special)
- Applicant: Home Diagnostics, Inc.
- Decided: Mar 27, 2009 after 30 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- 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.

## Recalls of this device
- Jun 28, 2016 · Class II · Z-2883-2016: Product gives incorrect low blood glucose levels.
- Oct 2, 2013 · Class II · Z-0909-2014: Manufactured with an incorrect factory set unit of measure.

## Indications for use
The TRUEbalance ,Blood Glucose System is intended for the quantitative determination of glucose in human capillary whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes. The alternative site (forearm) testing for the TRUEbalance Blood Glucose System can be used only during steady-state blood glucose conditions. The TRUEbalance Blood Glucose System is not intended for the diagnosis of or screening for diabetes mellitus.

Source page: https://510kreport.com/device/K090495
Methodology: https://510kreport.com/methodology