# K132821: Agamatrix Health Manager

- Pathway: 510(k) (Special)
- Applicant: Agamatrix, Inc.
- Decided: Nov 20, 2013 after 72 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: 4 generations back to K952279 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101597: Wavesense Diabetes Manager Model Version 1.3.4, Agamatrix (2010) Summary page 1.

## Indications for use
The AgaMatrix Health Manager is intended for single patent use. It is an accessory to blood glucose monitoring systems to assist in the review, analysis and evaluation of glucose results to aid in diabetes and health management. The AgaMatrix Health Manager collects data from AgaMatrix manufactured glucose meters and allows adding, editing, and viewing additional health data. The AgaMatrix Health Manager is not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare advice.

Source page: https://510kreport.com/device/K132821
Methodology: https://510kreport.com/methodology