# K120989: True Metrix Self-Monitoring Blood Glucose System, True Metrix Professional Monitoring Blood Glucose System

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Diagnostics, Inc.
- Decided: Apr 24, 2013 after 387 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
The TRUE METRIXTM Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. The TRUE N4ETRDO"m Self Monitoring Blood Glucose System is intended to be used by a single person and not be shared. The TRUE ME 'TRXThI Self Monitoring Blood Glucose System is intended for self-testing outside the body (in vito diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIXTM Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The TRUE METRIX Test Strips are for use with the TRUE METRIXrM Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. The TRUE METRIX Control Solution is for use with the TRUE METRIX Self Monitoring Meter and TRUE N4ETRIX Test Strips to check that the meter and the test strip are working together properly and that the test is performing correctly. The TRUE METRIX PRO0 Professional Monitoring Blood Glucose System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood. The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended for multiple-patient use in professional healthcare settings. Testing is performed outside the body (in vitro diagnostic use) as an aid for monitoring the effectiveness of diabetes control. TRUE METRIX PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not to be used on neonates or for the diagnosis or screening of diabetes mellitus. Alternative site testing can only be performed during steady-state blood glucose conditions. The TRUE METRIX PRO Test Strips are for use with the TRUE METRIX PRO Professional Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood. The TRUE METRIX Control Solution is for use with the TRUE METRIX PRO Professional Monitoring Meter and TRUE METRIX PRO Test Strips to check that the meter and test strip are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K120989
Methodology: https://510kreport.com/methodology