# K101633: Nova Max Plus Glocose and B-Ketone Control Solution-Mid, High

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: Aug 27, 2010 after 78 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K945887 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has 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 1.
- K070255: Nova Max Blood Glucose Monitor System, 90001,90002, Nova Biomedical Corp. (2007) Summary page 2.

## Indications for use
Nova Max Plus Glucose and β-Ketone Control Solutions are intended for use with the Nova Max Family of Monitors (Nova Max, Nova Max Plus, and Nova Max Link), BD Logic and Paradigm Link Monitors, Nova Max Glucose Test Strips, and Nova Max Plus Ketone Test Strips as a quality control check to verify the accuracy of blood Glucose and β-Ketone test results. There are two levels of Nova Max Plus Glucose and β-Ketone Control Solutions (Mid and High). Nova Max Plus Glucose and β-Ketone Control Solutions are for in vitro diagnostic use ONLY (for testing outside the body).

Source page: https://510kreport.com/device/K101633
Methodology: https://510kreport.com/methodology