# K070649: SMS Glucose Control, Model 2120061

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical Supply, Inc.
- Decided: Apr 12, 2007 after 35 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945887 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030703: Truetrack Smart System Blood Glucose Meter and True Track Smart System Blood Glucose Test Strips, Home Diagnostics, Inc. (2003) Summary page 1.
- K042080: Trackease Smart System Blood Glucose System, Home Diagnostics, Inc. (2004) Summary page 1.
- K052980: Liberty Glucose Control, Model 2120031, Liberty Healthcare Group, Inc. (2005) Summary page 2.

## Indications for use
For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Home Diagnostics TrackEASE Smart System® and TrueTrack Smart System® Blood Glucose Monitors.

Source page: https://510kreport.com/device/K070649
Methodology: https://510kreport.com/methodology