# K042080: Trackease Smart System Blood Glucose System

- Pathway: 510(k) (Special)
- Applicant: Home Diagnostics, Inc.
- Decided: Aug 19, 2004 after 16 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K070649: SMS Glucose Control, Model 2120061 (2007), 0 descendants of its own

## Recalls of this device
- Jun 28, 2016 · Class II · Z-2882-2016: Product gives incorrect low blood glucose levels.

## Indications for use
The TrackEASE 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/K042080
Methodology: https://510kreport.com/methodology