# K122688: Nova Max Mini Blood Glucose and B-Ketone Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Apr 4, 2013 after 212 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). 36 ancestors in all.
No later device cites it as a predicate yet.
2 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091547: Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max Blood Glucos, Nova Biomedical Corp. (2010) Summary page 2.
- K112638: Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips, Nova Biomedical Corporation (2012) Summary page 2.

## Indications for use
The Nova Max Mini Blood Glucose and 1-Ketone Monitor System is intended to be used for the quantitative measurement of glucose or 3-hydroxybutyrate (j3-ketone) in fresh capillary whole blood. It is 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 control. The Nova Max Mini Blood Glucose and j3-Ketone Monitor System is specifically indicated for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip or alternative site testing on the forearm, or 03-ketone in whole blood capillary samples obtained from the fingertip only. Glucose AST on the forearm can be used only during steady-state blood glucose conditions. The Nova Max Mini is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on neonates. The Nova Max Mini Blood Glucose Test Strips are intended for use only with the Nova Max Mini Blood Glucose Monitor System to quantitatively measure capillary blood glucose from the finger and forearm. The Nova Max Mini Ketone Test Strips are intended for use only on the Nova Max Mini Blood Glucose and P-Ketone Monitor System to quantitatively measure capillary j3-hydroxybutyrate from the finger. Nova Max Mini Glucose/Ketone Control Solutions are intended for use with the Max Mini Glucose or P-Ketone Test Strips as a quality control check to verify the accuracy of test results. There are two levels of controls, (Level 2 and Level 3).

Source page: https://510kreport.com/device/K122688
Methodology: https://510kreport.com/methodology