# K073573: Wavesense Keynote Codeless Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Agamatrix
- Decided: Jan 30, 2008 after 41 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 its predicate without a number.
- (no number) WaveSense Jazz Blood Glucose Monitoring System (Codeless): named in the summary without a submission number

## Indications for use
AgaMatrix WaveSense KeyNote Codeless 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.

Source page: https://510kreport.com/device/K073573
Methodology: https://510kreport.com/methodology