# K080641: Trueresult Blood Glucose System E4H01-81

- Pathway: 510(k) (Traditional)
- Applicant: Home Diagnostics, Inc.
- Decided: Aug 19, 2008 after 166 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices 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.

## Most influential descendants
- K122435: Nova One Blood Glucose Monitor (2012), 1 descendant of its own
- K131013: Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System (2013), 0 descendants of its own
- K112352: Glucose Meter-Check Control for Nipro Trueresult (2011), 0 descendants of its own
- K091460: Abt Glucose Control Solution Level 1,2,3 Model, 2120083,2120086, 2120087 (2009), 0 descendants of its own

## Recalls of this device
- Jun 28, 2016 · Class II · Z-2880-2016: Product gives incorrect low blood glucose levels.

## Indications for use
The TRUEresult Blood Glucose System is intended for the quantitative determination of glucose in human 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. Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing. Not for neonatal use.

Source page: https://510kreport.com/device/K080641
Methodology: https://510kreport.com/methodology