# K050224: 3TEST Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Neuero Engineering, Inc.
- Decided: Jul 13, 2005 after 163 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 K964630 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964630: Glucometer Elite Blood Glucose Meter, Bayer Corp. (1997) Summary page 1.

## Most influential descendants
- K072905: 3TEST Supreme Glucose Monitoring System (2008), 0 descendants of its own

## Indications for use
The 3test® Glucose test strip is intended to measure the glucose in whole blood with the 3test® Glucose Monitoring System. It is suitable for a person with diabetes to monitor their blood glucose at home by themselves. The 3test®Glucose Monitoring System can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood. NOTE: a. the 3test is to be used with capillary whole blood from the fingertip b. the Ntest is not for use with neonates c. the 3test meter is to be used with the 3test Blood Glucose Test Strip, and the 3test High and Low Glucose Control Solutions

Source page: https://510kreport.com/device/K050224
Methodology: https://510kreport.com/methodology