# K083265: Jazz Wireless Blood Glucose Monitoring System, Model 8000-03381

- Pathway: 510(k) (Special)
- Applicant: Agamatrix, Inc.
- Decided: Feb 3, 2009 after 90 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
AgaMatrix AgaMatrix JAZZ Wireless TM 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 JAZZ Wireless TM Blood Glucose Meter is intended for use with AgaMatrix JAZZ 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 JAZZ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ Wireless TM 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 WaveSense TM Control Solution is intended for use with the AgaMatrix JAZZ Wireless TM Meter and AgaMatrix JAZZ Wireless TM Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K083265
Methodology: https://510kreport.com/methodology