# K030703: Truetrack Smart System Blood Glucose Meter and True Track Smart System Blood Glucose Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Home Diagnostics, Inc.
- Decided: Jul 11, 2003 after 127 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K092645: Fdi Glucose Control Levels 1, 2 and 3 (2009), 0 descendants of its own
- K070649: SMS Glucose Control, Model 2120061 (2007), 0 descendants of its own

## Recalls of this device
- Jun 28, 2016 · Class II · Z-2881-2016: Product gives incorrect low blood glucose levels.
- Feb 25, 2013 · Class II · Z-1140-2013: Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.

## Indications for use
The TrueTrack Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

Source page: https://510kreport.com/device/K030703
Methodology: https://510kreport.com/methodology