# K130244: Diatrue Plus Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Delbio Incorporation
- Decided: Aug 23, 2013 after 204 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
DieTrue Plus Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample from the fingertip and the palm. The alternate site testing can be only used during steady-state blood glucose monitoring. The DiaTrue Plus Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates. The Dialrue Plus Blood Glucose Test Strips are used with the DieTrue Plus Glucose meter to quantitativeiy measure glucose in fresh capillary whole blood samples drawn from the fingertip and the palm. The DieTrue Glucose Control Solutions are for use with the DieTrue Plus Blood Glucose Test Strips and the DiaTrue Plus Glucose meter as a quality control check that the meter and test strip are working together properly, and that the test is performing correctly. The DieL-ife Mini Blood Glucose Management Software is designed for use in the home with the DieTrue Plus Blood Glucose Monitoring System to allow users to transmit data from meter to their computer. It is an optional data management software accessory for use with the DieTrue Plus Blood Glucose Monitoring System.

Source page: https://510kreport.com/device/K130244
Methodology: https://510kreport.com/methodology