# K241304: WaveSense Jazz Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Agamatrix
- Decided: Jun 6, 2024 after 28 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 K072413 (2007). 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)
- K072413: Modification to: Jazz Blood Glucose Monitoring System, Agamatrix (2007) Summary page 4.

## Indications for use
The WaveSense Jazz 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 of the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.

Source page: https://510kreport.com/device/K241304
Methodology: https://510kreport.com/methodology