# K093475: Basesens Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Hygeia, Inc.
- Decided: Feb 24, 2010 after 110 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: 3 generations back to K024194 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080923: Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C; Caresens Pop Meter, Model GM505EA or GM505EB, I-Sens, Inc. (2008) Summary page 2.
- K083468: Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color), I-Sens, Inc. (2009) Summary page 2.

## Indications for use
The BaseSens I Blood Glucose Monitoring System is used for the quantitative measurement of glucose levels in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. The BaseSens I Blood Glucose Monitoring System should be used only for testing outside the body (in vitro diagnostic use only). The BaseSens I Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions. BaseSens I Test Strip is used with the BaseSens I Blood Glucose Meter for quantitatively measuring glucose in capillary whole blood. The BaseSens I Test Strip is intended for self-testing outside the body (in vitro diagnostic use only). The BaseSens I Test Strips are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions. BaseSens I Control A&B Solutions are a red liquid to check that both the meters and test strips are working together properly. It contains a known range of glucose as written on the bottle.

Source page: https://510kreport.com/device/K093475
Methodology: https://510kreport.com/methodology