# K032657: Truetrack Smart System Blood Glucose Meter, Blood Glucose Test Strips, and Glucose Control Solutions (Low and High)

- Pathway: 510(k) (Traditional)
- Applicant: Home Diagnostics, Inc.
- Decided: Mar 24, 2004 after 209 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 3 (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-2881-2016: Product gives incorrect low blood glucose levels.
- Oct 2, 2013 · Class II · Z-0910-2014: Manufactured with an incorrect factory set unit of measure.
- 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 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.

Source page: https://510kreport.com/device/K032657
Methodology: https://510kreport.com/methodology