# K043543: Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: American Healthcare, Inc.
- Decided: Apr 8, 2005 after 109 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K942455 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024194: One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems, Lifescan, Inc. (2003) Summary page 2.
- K984261: Surestep Blood Glucose Monitoring System, Lifescan, Inc. (1999) Summary page 2.
- K021513: Accu-Chek Advantage Module, Roche Diagnostics Corp. (2002) Summary page 2.

## Indications for use
The FREEDOM Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The FREEDOM Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh and calf.

Source page: https://510kreport.com/device/K043543
Methodology: https://510kreport.com/methodology