# K063409: Liberty Blood Glucose Monitoring System, Model 8000-0067

- Pathway: 510(k) (Traditional)
- Applicant: Agamatrix
- Decided: Jan 12, 2007 after 60 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 K052762 (2006). 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)
- K052762: Liberty Blood Glucose Monitoring System, Model 8000-0067, Agamatrix, Inc. (2006) Summary page 1.

## Indications for use
AgaMatrix Liberria' Blood Glucose Monitoring System: AgaMatrix Liberty Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, palm, or forearm. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It isliotijitended for use With neonates. AgaMatrix LibertrM Blood Glucose Meter: AgaMatrix Liberty Blood Glucose Meter is intended for use with AgaMatrix Liberty" Blood Glucose Test Strips for thequantitative 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 (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. AgaMatrix Liberty T M Blood Glucose Test Strips: AgaMatrix Liberty' Blood Glucose Test Strips are intended for use with AgaMatrix LibertyTm Blood Glucose Meter 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 (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. AgaMatrix LibertyT h Control Solutions (Normal level and High level): AgaMatrix Liberty mControl Solutions are intended for use with the AgaMatrix LibertyT m Meter and AgaMatrix Liberty TM Test Strips as a quality control check to verify the accuracy of blood glucose test results,

Source page: https://510kreport.com/device/K063409
Methodology: https://510kreport.com/methodology