# K072413: Modification to: Jazz Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Agamatrix
- Decided: Sep 27, 2007 after 30 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K241304: WaveSense Jazz Blood Glucose Monitoring System (2024), 0 descendants of its own

## Indications for use
AgaMatrix JAZZTM Blood Glucose Monitoring System: AgaMatrix JAZZTM Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/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. AgaMatrix JAZZTM Blood Glucose Meter: AgaMatrix JAZZ TM Blood Glucose Meter is intended for use with AgaMatrix JAZZTM Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/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. AgaMatrix JAZZTM Blood Glucose Test Strips: AgaMatrix JAZZTM Blood Glucose Test Strips are intended for use with AgaMatrix JAZZTM Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/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. AgaMatrix JAZZTM Control Solutions (Normal level and High level): AgaMatrix JAZZTM Control Solutions are intended for use with the AgaMatrix JAZZTM Meter and AgaMatrix JAZZ TM Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K072413
Methodology: https://510kreport.com/methodology