# K103278: Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter; Acura Control Solution

- Pathway: 510(k) (Special)
- Applicant: I-Sens, Inc.
- Decided: Oct 28, 2011 after 357 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083468: Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color), I-Sens, Inc. (2009) Summary page 3.

## Most influential descendants
- K131419: Acura Plus Multi Blood Glucose Monitoring System (2013), 1 descendant of its own
- K151164: Assure Prism multi Blood Glucose Monitoring System (2015), 0 descendants of its own

## Indications for use
The ACURA PLUS Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The ACURA PLUS Blood Glucose Meter is intended for use with the ACURA PLUS Blood Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip and the alternate sites such as forearm, palm, thigh and calf. The alternate site testing should be used only during steady-state blood glucose conditions. The ACURA PLUS Control Solutions are for use with the ACURA PLUS Meter and ACURA PLUS Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. The ACURA PLUS Blood Glucose Monitoring System is intended for self testing outside the body by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis of or screening for diabetes.

Source page: https://510kreport.com/device/K103278
Methodology: https://510kreport.com/methodology