# K014167: Liberty Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Polymedica Pharmaceuticals, U.S.A., Inc.]
- Decided: Feb 19, 2002 after 62 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: 1 generation back to K993829 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993829: Accu-Chek Simplicity System, Roche Diagnostics Corp. (1999) Summary page 1.

## Indications for use
The Liberty™ Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. The Liberty™ Blood Glucose Meter is intended for use with Liberty™ Blood Glucose Strips for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. Liberty™ Blood Glucose Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Liberty™ Blood Glucose Meter. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. Liberty™ Control Solution is an aqueous glucose solution for use with the Liberty™ Blood Glucose System. It is used as a quality control check to verify the accuracy of the blood glucose test result. The Liberty™ Control Solution is intended for use in the validation of the performance of the Blood Glucose System by providing a test solution with a known range of glucose. A control test that falls within the acceptable range indicates the user’s technique is appropriate and the test strip and meter are functioning properly.

Source page: https://510kreport.com/device/K014167
Methodology: https://510kreport.com/methodology