# K103329: Diatrue Plus Blood Glucose Monitoring System; Diatrue Plus Blood Glucose Test Strip; Diatrue Glucose Control Solution

- Pathway: 510(k) (Traditional)
- Applicant: Delbio Incorporation
- Decided: Mar 13, 2012 after 487 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
DiaTrue Plus Blood Glucose Monitoring System: The DiaTrue Plus Blood Glucose Monitoring System is an in vitro diagnostic medical device intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control and should not be shared. The device should not be used for screening or diagnosis of diabetes or for testing neonates. DiaTrue Plus Blood Glucose Meter: The DiaTrue Plus Blood Glucose Meter is intended to use for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body. It is indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control. DiaTrue Plus Blood Glucose Test Strips: The DiaTrue Plus Blood Glucose Test Strips are intended to use for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The Blood Glucose Test Strips must be used with the DiaTrue Plus Blood Glucose Meter. Testing is done outside the body. They ate indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control. DiaTrue Glucose Control solution: For use with DiaTrue Blood Glucose Meter and DiaTrue Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Three levels of control solution are provided: Level 1, Level 11 and Level 1I1.

Source page: https://510kreport.com/device/K103329
Methodology: https://510kreport.com/methodology