# K062434: Zero-Click Data Management System, Model 8000-01528

- Pathway: 510(k) (Special)
- Applicant: Agamatrix
- Decided: Nov 13, 2006 after 84 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 K952279 (1995). 2 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994433: Connect Data Management System, Abbott Diabetes Care, Inc. (2000) Summary page 2.

## Most influential descendants
- K101597: Wavesense Diabetes Manager Model Version 1.3.4 (2010), 11 descendants of its own
- K103544: Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev D (2011), 9 descendants of its own
- K131230: Gmate Smart Blood Glucose Monitoring System, Gmate Smart Application (2014), 4 descendants of its own
- K150817: Dario Blood Glucose Monitoring System (2015), 2 descendants of its own
- K152365: AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (2016), 1 descendant of its own

## Indications for use
AgaMatrix Liberty™ Blood Glucose Monitoring 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 (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™ Blood Glucose Meter is intended for use with AgaMatrix Liberty Blood Glucose Test 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 (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™ Blood Glucose Test Strips are intended for use with AgaMatrix Liberty™ 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 Liberty™ Control Solution is intended for use with the AgaMatrix Liberty Meter and AgaMatrix Liberty Test Strips as a quality control check to verify the accuracy of blood glucose test results. AgaMatrix Zero-Click™ Blood Glucose Data Management System is intended for use in the home and professional settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the AgaMatrix Liberty™ Blood Glucose Monitoring System. The Zero-Click™ Blood Glucose Data Management System allows users to download Blood glucose reading automatically from the meter to the PC without clicking a button.

Source page: https://510kreport.com/device/K062434
Methodology: https://510kreport.com/methodology