# K122435: Nova One Blood Glucose Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Dec 20, 2012 after 132 days
- Product code: LFR (Glucose Dehydrogenase, 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: 10 generations back to K945887 (1995). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 34 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112638: Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips, Nova Biomedical Corporation (2012) Summary page 2.
- K080641: Trueresult Blood Glucose System E4H01-81, Home Diagnostics, Inc. (2008) Summary page 3.

## Most influential descendants
- K131013: Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System (2013), 0 descendants of its own

## Indications for use
The Nova One Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous, arterial and fresh capillary whole blood from the finger and forearm. It is intended for testing outside the body (invitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use, auto-disabling lancets. The Nova One Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on neonates. Alternative site testing on the forearm should be used only during steady-state blood glucose conditions. Nova One Blood Glucose Test Strips are for use with the Nova One Blood Glucose Monitors for quantitatively measuring glucose in venous, arterial and fresh capillary whole blood from the finger and forearm. The Glucose Monitor is calibrated to provide plasma equivalent results to laboratory methods. Nova One Glucose Test Strips are for testing outside the body (in vitro diagnostic use only). The Nova One Blood Glucose Monitor should only be used as directed. They are not intended for the diagnosis of or screening for diabetes, and are not intended for use on newborns. Nova Max Control Solutions are intended for use with the Nova Max, Nova Max One and Nova One Blood Glucose Monitoring Systems as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Levels 1, 2, 3).

Source page: https://510kreport.com/device/K122435
Methodology: https://510kreport.com/methodology