# K052762: Liberty Blood Glucose Monitoring System, Model 8000-0067

- Pathway: 510(k) (Traditional)
- Applicant: Agamatrix, Inc.
- Decided: Jan 23, 2006 after 115 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
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K023657: Ascensia Contour Blood Glucose Monitoring System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K063855: Liberty Normal Glucose Control Solution, Model 2120045/ High Glucose Control Solution, Model 2120047 (2007), 1 descendant of its own
- K112356: Glucose Meter-Check Control Solution for Agamatrix Wavesense (2011), 0 descendants of its own
- K090943: Abt Glucose Control Solution, Model: 2120089 (2009), 0 descendants of its own
- K063409: Liberty Blood Glucose Monitoring System, Model 8000-0067 (2007), 0 descendants of its own

## Indications for use
AgaMatrix Liberty TM 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 and palm of the hand. 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 TM Blood Glucose Meter: AgaMatrix Liberty TM Blood Glucose Meter is intended for use with AgaMatrix Liberty TM Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip and palm of the hand. 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 M Blood Glucose Test Strips: AgaMatrix Liberty Blood Glucose Test Strips are intended for use with AgaMatrix Liberty TM Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip and palm of the hand. 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 M Control Solutions (Normal level and High level): AgaMatrix Liberty M Control Solutions are intended for use with the AgaMatrix Liberty TM 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/K052762
Methodology: https://510kreport.com/methodology