# K112638: Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Mar 9, 2012 after 182 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
Longest line of descent: 9 generations back to K945887 (1995). 30 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K070255: Nova Max Blood Glucose Monitor System, 90001,90002, Nova Biomedical Corp. (2007) Summary page 2.
- K051839: Free-Style Freedom Blood Glucose Monitoring System, Model 11001, Abbott Diabetes Care, Inc. (2006) Summary page 1.
- K092638: Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23, Abbott Diabetes Care, Inc. (2010) Summary page 1.

## Most influential descendants
- K122435: Nova One Blood Glucose Monitor (2012), 1 descendant of its own
- K131013: Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System (2013), 0 descendants of its own
- K122688: Nova Max Mini Blood Glucose and B-Ketone Monitor (2013), 0 descendants of its own

## Indications for use
The Nova Max One Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. Itis intended for single-patient home use and should not be used for testing multiple patients. It is intended for self testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes contmol. The Nova Max One Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in fresh whore blood capillary samples obtained from the fingertip or alternative site testing (AST) on the forearm. AST on the forearm can be used only during steady-state blood glucose conditions. It is not intended for the diagnosis of or screening for diabetes. and it is not intended for use on newborns. Nova Max One Glucose Test Strips are intended for use only with the Nova Max One Blood Glucose Monitor for quantitative tests. The Glucose Monitor isintended to quantitatively measure glucose (sugar) in fresh capillary whole blood obtained from the finger tip or alternative site testing (AST) on the forearm. AST can be used only during steady-state blood glucose conditions. The Glucose Monitor is calibrated to provide plasma equivalent results to laboratory methods. Nova Max One Glucose Test Strips are for testing outside the body (invitro diagnostic use only). The Monitor should only be used by a single user in the home and should not be shared by users. It is not intended for the diagnosis of or screening for diabetes, and it is not. intended for use on newborns. Nova Max Control Solutions are intended for use with the Nova Max 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/K112638
Methodology: https://510kreport.com/methodology