# K033433: Nova Glucose Control Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: Jan 2, 2004 after 66 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Nova Glucose Control Solution assayed quality control material is used to verify the performance of BD Glucose Monitoring Systems and the BD/Medtronic MiniMed Blood Glucose Monitoring Systems. This control is an OTC product intended for use in the home setting. The Nova Glucose Control Solutions are for in vitro diagnostic use ONLY.

Source page: https://510kreport.com/device/K033433
Methodology: https://510kreport.com/methodology