# K091547: Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max Blood Glucos

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: Jan 15, 2010 after 233 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 10 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945887 (1995). 13 ancestors in all.
10 later devices descend from it; 7 cite it directly.
1 of 24 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 1.
- K040814: Modification to Precision Xtra Advanced Diabetes Management System, Abbott Laboratories (2004) Summary page 2.

## Most influential descendants
- K161738: FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems (2016), 2 descendants of its own
- K170463: KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System (2018), 1 descendant of its own
- K201037: FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System (2022), 0 descendants of its own
- K202534: MTM301 Blood Glucose and Ketone Monitoring System (2022), 0 descendants of its own
- K201880: MultiSure GK Link Blood Glucose and Ketone Monitoring System (2021), 0 descendants of its own

## Recalls of this device
- Jul 15, 2013 · Class I · Z-1901-2013: Reports of false abnormally high glucose readings from test strips
- Jul 15, 2013 · Class I · Z-1905-2013: Reports of false abnormally high glucose readings from test strips
- Jul 15, 2013 · Class I · Z-1897-2013: Reports of false abnormally high glucose readings from test strips
- Jul 15, 2013 · Class I · Z-1902-2013: Reports of false abnormally high glucose readings from test strips
- Jul 15, 2013 · Class I · Z-1903-2013: Reports of false abnormally high glucose readings from test strips
- Jul 15, 2013 · Class I · Z-1899-2013: Reports of false abnormally high glucose readings from test strips
- Jul 15, 2013 · Class I · Z-1898-2013: Reports of false abnormally high glucose readings from test strips
- Jul 15, 2013 · Class I · Z-1906-2013: Reports of false abnormally high glucose readings from test strips
- Jul 15, 2013 · Class I · Z-1900-2013: Reports of false abnormally high glucose readings from test strips
- Jul 15, 2013 · Class I · Z-1904-2013: Reports of false abnormally high glucose readings from test strips

## Indications for use
The Nova Max Plus Blood Glucose and β-Ketone Monitoring System Monitor is intended to be used for the quantitative measurement of glucose or β-hydroxybutyrate (β-ketone) in fresh capillary whole blood. It is intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The Nova Max Blood Glucose and β-Ketone Monitor is specifically indicated for the quantitative measurement of glucose in fresh capillary whole blood samples obtained from the fingertip, forearm and palm or β-hydroxybutyrate (β-ketone) in fresh capillary whole blood obtained from the fingertip only. Nova Max Glucose Test Strips are intended for use only with the Nova Max Blood Glucose Monitor and the Nova Max Plus Blood Glucose and β-Ketone Monitor. The Glucose Monitor is calibrated to provide plasma equivalent glucose results to laboratory methods. Nova Max Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use only). The Nova Max Plus Ketone Test Strips are intended for use only on the Nova Max Plus Blood Glucose and β-Ketone Monitor. Nova Max Glucose Control Solutions are intended for use with the Nova Max Blood Glucose Monitor and the Nova Max Plus Blood Glucose and β-Ketone Monitor and Nova Max Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. There are three levels of glucose controls, (Normal, Low, High). Nova Max Plus Ketone Control Solutions are intended for use with the Nova Max Plus Blood Glucose and β-Ketone Monitor and the Nova Max Plus Ketone Test Strips as a quality control check to verify the accuracy of blood ketone test results. There are three levels of ketone controls, (Levels 1, 2 and 3).

Source page: https://510kreport.com/device/K091547
Methodology: https://510kreport.com/methodology